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Research Article | DOI: https://doi.org/10.31579/2637-8892/235
1 Affiliation: Imam Khomeini hospital complex, Tehran University of Medical Sciences, Tehran, Iran.
2 Affiliation: Imam Khomeini Medical and Research Centre, Tehran University of Medical Sciences, Tehran, Iran.
3 Affiliation: Islamic azad university, school of food industrial engineering, Tehran, Iran.
4 Affiliation: PhD of Medical Education, National Nutrition and Food Technology Research Institute, Shahid Beheshti University of medical sciences.
5 Affiliation: Iran university of medical sciences, School of medicine, Tehran, Iran.
*Corresponding Author: Kianoush Saberi, Affiliation: Imam Khomeini hospital complex, Tehran University of Medical Sciences, Tehran, Iran.
Citation: Kianoush Saberi, Mehrdad Salehi, Hasti Saberi, Shahnaz Sharifi, Hosein Saberi. (2023), Effect of Perioperative Administration of Dexmedetomidine in Cardiac Surgeries: A Double-Blind, Placebo-Controlled Trial, Psychology and Mental Health Care, 7(7): DOI:10.31579/2637-8892/235
Copyright: © 2023, Surya S. Singh. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Received: 25 September 2023 | Accepted: 10 October 2023 | Published: 17 October 2023
Keywords: dexmedetomidine; cardiac-surgery; atrial-fibrillation
Introduction: Despite many developments in the health care of cardiac surgery patients, yet 5-30% of them may become challenged due to renal dysfunction, delirium, and arrhythmia. Eliminating or reducing these unwanted outcomes is likely to improve the prognosis of them. Several studies suggested that dexmedetomidine (DEX), a highly selective short-acting α-2 adrenergic agonist predominantly used for anti-delirium and sedative characteristics, may be useful for reducing the adverse effect of cardiac surgeries. The purpose of the current study was to investigate the outcome of the administration of dexmedetomidine in patients undergoing cardiac surgeries.
Method: We included the data from patents who underwent CABG without a valve, CABG with valve surgery, and valve-only surgery from August 2018 to November 2018. A total of 51 patients were eligible for our study after extraction. For the DEX group, the infusion of DEX was started 10 minutes before anesthesia induction in a 0.2-0.6 µg/Kg/h rate. And the same amount of normal saline 0.9% was infused for the control group. The infusion was continued postoperatively until extubation (maximum for 24 hours). The patients were compared primarily for Acute Kidney Injury (AKI), delirium, new-onset atrial fibrillation (AF) rhythm.
Results: We had a total of 51 patients which 33(64.70%) received DEX, and 18(35.29%) received a placebo. There was no significant difference between groups for demographic data. One patient (16.7%) from the DEX group and 5 patients (83.3%) from the control group revealed an AF rhythm after surgery (p=0.009). No patient faced delirium. 7 patients seemed to be AKI, of which 5(71.4%) were in the DEX group, and 2(28.6%) were in the control group (p>0.05).
Conclusion: there might be a meaningful reduction of new-onset AF rhythm in adult patients who use DEX after cardiac surgeries.
Before introduction of coronary artery bypass grafting (CABG), a reliable method for healing coronary stenosis, most of the patients must undergo cardiac arrest using a cardiopulmonary pump (CPB); the traditional approach of using CPB gave its place to the newer off-pump coronary artery bypass grafting with respect to fixation technology
[1]. Despite these and many other developments, yet 5-30% of patients undergoing cardiac surgeries may become challenged due to renal dysfunction[2], delirium[3,4], pathological changes in electrocardiogram (EKG) rhythms[5]. Eliminating or reducing these unwanted outcomes is likely to improve the prognosis in patients who have undergone cardiac surgery. Therefore, various approaches, tools, and drugs have been clinically applied to reduce the incidence of postoperative issues. Several studies, consisting of laboratory and clinical researches, suggested that dexmedetomidine (DEX) may be useful for reducing the adverse effect of cardiac surgeries [6,7]. Studies indicated that dexmedetomidine is associated with fewer incidences of postoperative complications in patients undergoing cardiac surgery. Current guidelines suggest using either propofol or dexmedetomidine instead of benzodiazepines to improve clinical outcomes [3]. Dexmedetomidine is a highly selective, short-acting α-2 adrenergic agonist that initially has been used as an intravenous anti-delirium drug in ICU and then approved as a sedative [8]. Besides safe and effective sedation, it may significantly reduce the use of analgesics, β-blockers, antiemetics, epinephrine, and diuretics. Recent studies also found that DEX has a protective effect on the kidney [7]. Kidney injury can lead to renal insufficiency, hyperkalemia, water intoxication, fatal arrhythmia, and cerebral edema, which are often life-threatening. Dexmedetomidine decreases the norepinephrine level in the blood, and thus it induces renal artery vasodilatation and increases renal blood flow and urine output[9]. The purpose of the current study was to investigate the outcome of administration of dexmedetomidine in patients undergoing cardiac surgeries from different aspects such as hemodynamic stability, EKG rhythm pathologic changes, delirium occurrence, kidney function, sedation-agitation status, pain feeling in ICU, time of mechanical ventilation, etc.
Method:
After obtaining the confirmation of the Tehran University of medical sciences ethics committee, all patients who meet our criteria at Imam Khomeini hospital, a university-based 1100 bed center, from August 2018 to November 2018 entered our study. Our inclusion criteria were anyone who is a candidate for CABG without a valve, CABG with valve surgery, and valve-only surgery during this period. We did not enter the patients with any aorta complication or any surgery that needed deep hypothermic circulatory arrest. A total of 72 patients entered the study, in which 21 cases were excluded from the study concerning our exclusion criteria. Our exclusion criteria were any urologic or nephrological problem consist of: a base creatinine more than 2, history of permanent or temporary dialysis, hydronephrosis or kidney infection, history of contrast administration for MRI or CT-scan, urine retention and using diapers or foley catheter and any renal surgery such as nephrectomy or transplant; Also, we excluded the patients with history of long-term sedative drugs (such as oxazepam, diazepam, clonazepam, alprazolam, gabapentin, etc.), history of antidepressant use ( such as sertraline, fluoxetine, fluvoxamine, etc.), any drug abuse, exciter drugs usage (like crystal, Ritalin, cocaine, etc.), any sleep disorder detected in tests and Non-Invasive ventilator extended usage. A total of 51 patients entered our study who 31(%) of them were in the dexmedetomidine (DEX) group, and 18(%) were in control group who double blindly received whether dexmedetomidine infusion of normal saline 0.9% and then data were extracted retrospectively according to patients’ file; neither the clinical staffs (consist of anesthesia crew, surgical crew and nursing group), nor data analyzer was aware of the groups until the end of analyze. We infused dexmedetomidine, 10 min. Before anesthesia induction in a 0.2-0.6 µg/Kg/h. An arterial-line was then fixed in the radial or brachial site. After standard monitoring (consist of a 5-lead EKG, pulse oximetry, and non-invasive blood pressure) The induction of anesthesia was performed using propofol, fentanyl, midazolam, atracurium. Anesthesia was then maintained using an infusion of midazolam and propofol. A routine ABG was sent before induction, 5 min. after induction, before cross-clamp, during the pump as needed and after disconnecting from the pump and before transferring to ICU. ABG was assessed, and improvement of ventilator tidal volume and respiratory rate was adjusted as needed along with drug administration if needed. An end-tidal CO2 of 35-45 was considered as normal. DEX infusion was continued postoperatively until weaning from the ventilator. If the patient was not extubated after 24 hours, it was discontinued due to FDA recommendations on safe administration of DEX. If any drug needed infusion during and after the surgery, the data was documented. The data for hemodynamic (HR, systolic, and diastolic pressure) was documented during and after the surgery, according to the standard sheet. Mean arterial pressure (MAP) was then calculated using the formula and compared before induction and average of postoperative data. Richmond agitation-sedation scale (RASS)
[Table1]
| Richmond Agitation-Sedation Scale | ||
| Score | Term | Description |
| +4 | Combative | Overtly combative, violent, danger to staff |
| +3 | Very agitated | Pulls or removes tubes or catheters; aggressive |
| +2 | Agitated | Frequent no purposeful movement, fights ventilator |
| +1 | Restless | Anxious, but movements not aggressive or vigorous |
| 0 | Alert and calm | ... |
| −1 | Drowsy | Not fully alert, but has sustained awakening (eye opening/eye contact) to voice (> 10 s) |
| −2 | Light sedation | Briefly awakens with eye contact to voice (< 10> |
| −3 | Moderate sedation | Movement or eye opening to voice (but no eye contact) |
| −4 | Deep sedation | No response to voice, but movement or eye opening to physical stimulation |
| −5 | Unable to rouse | No response to voice or physical stimulus |
and critical-care pain observation tool (CPOT) [Table2]
| The Critical-Care Pain Observation Tool (CPOT) | ||
| Indicator | Score | Description |
| Facial expression | Relaxed, neutral 0 | No muscle tension observed |
| Tense 1 | Presence of frowning, brow lowering, orbit tightening and levator contraction or any other change (e.g. opening eyes or tearing during nociceptive procedures) | |
| Grimacing 2 | All previous facial movements plus eyelid tightly closed (the patient may present with mouth open or biting the endotracheal tube) | |
| Body movements | Absence of movements 0 or normal position | Does not move at all (doesn’t necessarily mean absence of pain) or normal position (movements not aimed toward the pain site or not made for the purpose of protection) |
| Protection 1 | Slow, cautious movements, touching or rubbing the pain site, seeking attention through movements | |
| Restlessness/Agitation 2 | Pulling tube, attempting to sit up, moving limbs/thrashing, not following commands, striking at staff, trying to climb out of bed | |
Compliance with the ventilator (intubated patients)
OR
Vocalization (extubated patients) | Tolerating ventilator or movement 0 | Alarms not activated, easy ventilation |
| Coughing but tolerating 1 | Coughing, alarms may be activated but stop spontaneously | |
| Fighting ventilator 2 | Asynchrony: blocking ventilation, alarms frequently activated | |
Talking in normal tone or no sound 0 | Talking in normal tone or no sound | |
| Sighing, moaning 1 | Sighing, moaning | |
| Crying out, sobbing 2 | Crying out, sobbing | |
Muscle tension Evaluation by passive flexion or extension of upper limbs when patient is at rest or evaluation when patient is being turned | Relaxed 0 | No resistance to passive movements |
| Tense, rigid | Resistance to passive movements | |
| Very tense or rigid 2 | Strong resistance to passive movements or incapacity to complete them | |
| Total CPOT Score | ……/8 | |
was assessed according to Table1. Daily routine experiments for all the patients were BUN, Creatinine, Hematocrit, Hemoglobin, Platelets count, and WBC. The initial goal of the study was to detect AF rhythm from EKG interpretation, AKI, according to the latest KDIGO guidelines, delirium assessed by the Confusion Assessment Method for Intensive Care Unit (CAM-ICU) [Table3],
| The Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) |
| Features and descriptions |
| a. Acute onset or fluctuating course |
A. Is there evidence of an acute change in mental status from the baseline? B. Or, did the (abnormal) behavior fluctuate during the past 24 hours, that is, tend to come and go or increase and decrease in severity as evidenced by fluctuations on the Richmond Agitation Sedation Scale (RASS) or the Glasgow Coma Scale? |
| b. Inattention |
| Did the patient have difficulty focusing attention as evidenced by a score of less than 8 correct answers on either the visual or auditory components of the Attention Screening Examination (ASE)? |
| c. Disorganized thinking |
Is there evidence of disorganized or incoherent thinking as evidenced by incorrect answers to three or more of the 4 questions and inability to follow the commands? Questions 1. Will a stone float on water? 2. Are there fish in the sea? 3. Does 1-pound weigh more than 2 pounds? 4. Can you use a hammer to pound a nail? Commands 1. Are you having unclear thinking? 2. Hold up this many finger. (Examiner holds 2 fingers in front of the patient.) 3. Now do the same thing with the other hand (without holding the 2 fingers in front of the patient). (If the patient is already extubated from the ventilator, determine whether the patient’s thinking is disorganized or incoherent, such as rambling or irrelevant conversation, unclear or illogical flow of ideas, or unpredictable switching from subject to subject.) |
| d. Altered level of consciousness |
Is the patient’s level of consciousness anything other than alert, such as being vigilant or lethargic or in a stupor or coma? alert: spontaneously fully aware of environment and interacts appropriately vigilant: hyperalert lethargic: drowsy but easily aroused, unaware of some elements in the environment or not spontaneously interacting with the interviewer; becomes fully aware and appropriately interactive when prodded minimally stupor: difficult to arouse, unaware of some or all elements in the environment or not spontaneously interacting with the interviewer; becomes incompletely aware when prodded strongly; can be aroused only by vigorous and repeated stimuli and as soon as the stimulus ceases, sporous subject lapses back into unresponsive state coma: unarousable, unaware of all elements in the environment with no spontaneous interaction or awareness of the interviewer so that the interview is impossible even with maximal prodding |
| Is delirium available? |
mechanical ventilation by minutes and days of ICU stay after surgery. The sample size was estimated using IBM SPSS sample power (release 3.0.1);17 patients were sufficient for each group to achieve a power of 80% considering type one error of less than 5%. Data were analyzed using IBM SPSS Statistics (version 25) and expressed as Mean (lower bond-upper bond confidence interval95%) for continuous variables and Number(percentage) for categorical variables. Data then were analyzed using one-way ANOVA for continuous data and Chi-square for categorical data. A p-value of less than 0.05 considered significant.
We had a total of 51 persons;33(64.70%) in the DEX group and 18(35.29%) in the control group. 30(58.8%). Patients characteristics before surgery are defined in [Table 4].
| Variables | DEX group (n = 33) | Control group (n =18) | P value |
| Age (years) | 51.18±16.18 | 53.72±19.89 | 0.623 |
| Weight (kilograms) | 71.36±17.46 | 76.11±15.52 | 0.339 |
| Height (Centimeters) | 168.30±20.25 | 170.50±7.57 | 0.660 |
| Female gender | 20(60.60%) | 10(55.55%) | 0.476 |
| HTN | 14(63.63%) | 8(36.36%) | 0.673 |
| Thyroid disease | 3(9.09%) | 0(0.00%) | 0.543 |
| Cigarette smoking | 7(21.21%) | 2(11.11%) | 0.464 |
| EF | 40.60±16.16 | 34.00±15.80 | 0.166 |
| MAP | 91.38±29.70 | 92.44±14.09 | 0.887 |
| HR | 73.27±27.98 | 69.77±29.08 | 0.676 |
| Systolic BP | 132.21±45.69 | 133.33±20.95 | 0.922 |
| Diastolic BP | 70.96±22.88 | 72.00±13.21 | 0.861 |
| Creatinine base | 1.05±0.42 | 1.41±0.79 | 0.038 |
| Hemoglobin base | 10.26±3.94 | 11.40±3.43 | 0.309 |
Abbreviations: HTN = Hypertension; EF = Ejection Fraction; MAP = Mean Arterial Pressure; HR = Heart Rates; BP = Blood Pressure.
Table 4: patients’ characteristics
From the interpretation of the 12 lead EKG of the patients before the surgery, 3(5.9%) had an AF rhythm which 2(66.7%) were in the DEX group, and 1(33.3%) were in the control group (p>0.05). No bradycardia was reported. Only one (3%) of the DEX patients had more than 140 beats per minute tachycardia, and no one in the control group had presented with tachycardia (p>0.05). Neither PAC nor PVC rhythm was detected in this research. Also, EKGs indicated no flutter, myocardial infarction, and ischemic heart disease. 28(63.6%) of the patients with normal cardiac rhythm were in the DEX group, and 16(36.4%) of them were in our control group (p>0.05).
A total of 27(52.9%) of the patients had only done CABG surgery, 18(54.5%) from the DEX group and 9(50.0%) from the control group (p>0.05). Data from perioperative time and surgery details are summarized in [Table 5].
| variables | DEX group (n = 33) | Control group (n = 18) | P value |
| Surgery type | |||
| CABG | 18(66.66%) | 9(33.33%) | 0.492 |
| Valve(s) | 10(76.92%) | 3(23.07%) | 0.235 |
| CABG + Valve(s) | 4(50.00%) | 4(50.00%) | 0.287 |
| Pump time (Min.) | 75.27±66.18 | 88.88±47.22 | 0.621 |
| Cross-clamp time (Min.) | 48.00±47.22 | 43.05±43.09 | 0.714 |
| Off-pump surgery | 4(12.12%) | 2(11.11%) | 0.646 |
| Total surgery time (Minutes) | 373.27±129.71 | 256.55±112.62 | 0.819 |
| Serum intake (cc) | 4606.06±1303.58 | 4066.66±1429.10 | 0.178 |
| Blood and blood products intake | 14(42.42%) | 6(33.33%) | 0.371 |
| Diuresis (cc) | 1043.93±681.19 | 758.33±645.85 | 0.151 |
Data are described as Mean ± Standard deviation or Number (percentage within group)
Table 5: Perioperative data
During the surgery, a total of 20(39.2%) patients required blood products (packed cell, fresh frozen plasma, platelets); 14(42.4%) of the DEX patients and 6(33.3%) of the control group (p>0.05). 8(24.2%) of the DEX group and 3(16.7%) of the control group needed electroshock due to surgeons’ demand (p>0.05). In the routine ABGs, we detected 2(6.1%) acidosis in the DEX group and 1(5.6%) in the control group (p>0.05) from which all three of them needed improvement with Sodium bicarbonate (p>0.05) and all of them solved (p>0.05).
A total of 25(49.0%) of the patients needed an infusion of epinephrine, which consists of 14(42.4%) of the DEX group and 11(61.1%) of the control group (p>0.05). Also, one patient from each group (3.0% of DEX and 5.6% of the control group) needed norepinephrine (p>0.05). 28(84.8%) of the DEX group and 17(94.4%) of the control group received midazolam infusion (p>0.05). Also, 28(84.8%) of the DEX patients and 16(88.9%) of the control group sedated with fentanyl drip (p>0.05). Only 2(6.1%) of the DEX patients needed dopamine, and none of the control group needed, such (p>0.05). No patient received milrinone. 16 (48.5%) of the DEX group and 11(40.7%) of the control group required TNG due to hypertension (p>0.05). One of the DEX (3.0%) and one of the control group (5.6%) received furosemide infusion (p>0.05). Mean MAP before surgery for the DEX group was 91.38(80.84-101.91 CI95%), and for the control group was 92.44(85.43-99.45 CI 95%) (p>0.05). After the surgery, during the stay in ICU, the mean MAP was 61.12(55.43-66.81 CI 95%) in the DEX group and 65.50(56.23-74.77 CI95%) in control group (p>0.05).
The mean total mechanical ventilation time was 589.36(527.66-651.06 CI 95%) minutes in the DEX group and 521.11(409.50-632.71 CI 95%) minutes in the control group(p>0.05). Total ICU stays in the day had a mean of 2.36 days in the DEX group and 2.77 days in the control group (p>0.05). From our endpoints, 6 patients came front with AF Rhythm, which only 1(16.7%) of them were from the DEX group and the other 5(83.3%) were from the control group(p=0.009). No patient required dialysis after the surgery. No patient underwent redo surgery, and no one faced delirium. 7 patients seemed to be AKI, which 5(71.4%) were in the DEX group, and 2(28.6%) were in the control group (p>0.05).
This research was designed to investigate the effect of dexmedetomidine on patients undergoing cardiac surgery. Our primary endpoint was to compare the AKI occurrence between the DEX group and the placebo group. The results did not show any significant difference between the group who received DEX and the control group for AKI; indeed, we had a total of 7 AKI patients, which according to KDIGO classification, 2 of them were stage 2 and no patient from current study became stage3 AKI. There is a different possibility for this result; first that in our study, we used different drugs, especially midazolam and fentanyl, along with DEX which may affect the renoprotective characteristic of DEX(7). In a study from Ammar et al., creatinine increased significantly higher in the DEX group on day1. Also, they reported DEX might provide cardiac and renal protection during cardiac surgery though it had no impact on postoperative outcomes(1, 8, 10). However, some studies suggested that it may have a favorable impact on outcomes in patients with preexisting cardiac and/or renal dysfunction(11). In our study, we had excluded patients with any renal complication, and more studies on those patients are recommended. The results contradicted that of Liu et al. whereas they concluded perioperative administration of DEX in adult patients undergoing cardiac surgery might reduce the incidence of postoperative AKI(12). Future trials are needed to reduce the contradiction in nephrological effects of DEX in cardiac surgery patients. Another reason that increases the rate of AKI is low blood pressure and/or unstable hemodynamics. The etiology of renal injury is due mainly to the elevation of renin levels as a result of sympathetic overactivity in addition to nephrotoxic, inflammatory, and hemodynamic components. The patients in our study had a mean MAP of 91.38 for the DEX group and 92.44 for the control group before surgery and 61.12 for the DEX group and 65.50 for the control group after surgery. The results were not statistically significant, which was in line with Chang et. Al. study(13); Despite this fact, we see a lower MAP in the DEX group, which may explain why we had more AKI in the DEX group than in the control group. Despite diminution in blood pressure, the pain-relieving characteristics of DEX are questionable. In a study about fast-track management in off-pump CABG from Zientara et al., the DEX group needed less use of pain medication in the initial phase at ICU(8). In the current research, 84.8% of the DEX group and 88.9% of the control group required fentanyl infusion. These results revealed that most of the patients with or without DEX might need another pain-reliever. In our study, we chose to use an infusion of fentanyl instead of any drug stat administration, because the strategy in controlling pain is to prevent it beforehand, instead of healing it. In contrary to DEX low-potency in relieving pain, it can significantly increase the time of weaning. Mean mechanical ventilation time for the DEX group was 68 minutes higher compare to the control group; this was contrary to some other studies(8, 14) whereas they used propofol infusion for their control group. Although we used a placebo instead of propofol or any other drugs, for reaching a RASS about -1 to -2, we need to perfused more of midazolam and fentanyl in the control group. This might explain why, in some cases, DEX group wanted more time for weaning from ventilator. Although dexmedetomidine has effects on the brain locus coeruleus and the a2-adrenergic receptors of the spinal cord to result in sedation, sympatholytic, analgesia, and antinociception, both groups had the same CPOT and RASS in our study. This was in line with some other studies(15). Besides, DEX did not show any benefit in deep sedation(16) , and because of that, we should only consider it as an adjuvant to other drugs. The current research did not show any difference between groups for pain. This was contrary to some studies; among them a meta-analysis from Wang et al. reported that DEX could effectively relieve the pain intensity, extend the pain-free period, and decrease the consumption of opioids during postoperative recovery of adults in general anesthesia(17); however, their study extracted the data only from one cardiac surgery article. Further, another study in non-cardiac ICU suggests the advantage of DEX in analgesia(18). Indeed, we recommend a study explicitly designed for assessment of DEX capability to relieve pain in cardiac surgery patients; because the power of sample of our study was according to AKI-occurrence, the results cannot be trusted alone. All the patients experienced a mean ICU stay of about 2 days, and there was no difference between groups from that aspect of view. The results indicated a meaningful difference between groups for a new-onset AF rhythm after the surgery. This was in line with some other studies(5, 8) and explain the antiarrhythmic characteristic of DEX(19). However, a meta-analysis by zhu et al.(20) revealed that DEX could not reduce the incidence of AF compared to control medicines following cardiac surgery. DEX might have an increased influence on AF occurrence if patients had a history of AF. We had 3 patients in our study, which had AF rhythm before surgery, but none of them had AF rhythm after surgery. Most studies suggest that the postoperative administration of dexmedetomidine may reduce delirium in patients, particularly following cardiac surgery(2-4, 6, 21). We used the CAM-ICU tool to screen for delirium based on four features: (a) a fluctuating mental status, (b) inattention, (c) disorganized thinking, and; (d) altered level of consciousness. For the determination of delirium, a patient must display features (a) and (b), with either (c) or (d). In the current study, patients had not delirium. This may be a result of having a mean RASS of -2, which indicated a good and deep sleep. Although DEX known to improve the quality of sleep in critically ill patients(3, 22),reduces agitation(23) and reduce pain after cardiothoracic surgery(24, 25), we did not see any difference of RASS and CPOT between groups. This is probably due to the fact that patients from both groups received midazolam and fentanyl as needed.
The results from current research indicated that there might be a meaningful reduction of new-onset AF rhythm in adult patients who use DEX after cardiac surgeries. Further studies for achieving a more reliable result on DEX antiarrhythmic effects is suggested.
None.
Because current study was a retrograde research, the need for clinical trial registration was waved by the ethics committee of Tehran University of Medical sciences due to lack of clinical intervention.
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