To Evaluate if Dexmedetomidine Infusion Provides Renal Protection in Patients Undergoing Coronary Artery Bypass Graft

• Status: Completed
• Trial end date: 2022-01-31
• Target enrollment: 0
• Participant gender: All

Summary

OBJECTIVE: Aim of this study is to follow and compare the changes in serum creatinine and urine output up to 48 hours of surgery in patients receiving dexmedetomidine infusion in addition to standard protocol (Experimental Group) as compared to the patients receiving standard protocol alone. (Control Group) in patients undergoing isolated coronary artery bypass grafting surgery (CABG) at a tertiary care cardiac center of Karachi, Pakistan.

STUDY DESIGN: Randomized control trial

PLACE & DURATION OF STUDY: The research will be conducted in the Department of Anesthesia & Intensive Care, National Institute of Cardiovascular Diseases (NICVD), Karachi. 6 months (01/08/2021 to 31/1/2022).

DATA COLLECTION PROCEDURE: This study was conducted among 60 patients allocated randomly into two groups. In the study group (group D), dexmedetomidine was given as an infusion of 0.4 μg/kg/h from induction of anesthesia for 24 hours. In the control group (group C), the patients were receiving an equal volume of normal saline.

PRIMARY OUTCOME: The primary outcome of the study was Serum Creatinine (mg/dl) which was measured before the surgery at baseline and then 48 hours after surgery.

SECONDARY OUTCOMES: The secondary outcomes were incidence of urine output per hour for up to 48 hours after surgery, operative time from induction of anesthesia till skin closure, aortic cross-clamp time from application of aortic cross-clamping till aortic declamping, CPB time from connecting the patient to extracorporeal circulation till termination of CPB, duration of ICU stay from transferring the patient from the operating room to the ICU till patient discharge to the ward, episodes of bradycardia and hypotension, dosage of inotropics and hemoglobin levels at baseline and up to 48 hours.

KEYWORDS: cardiac surgery-associated acute kidney injury, dexmedetomidine, serum creatinine.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Cardiovascular Diseases, Karachi
• Treatments: Dexmedetomidine

Criteria

Inclusion Criteria:

Ages ranged between 18 and 65 years.

• Patients undergoing isolated coronary artery bypass grafting.

• Class II and III ASA physical status.

Exclusion Criteria:

• Patients with preoperative renal impairment (elevated creatinine and blood urea nitrogen levels) and diuretic use.

• Preexisting hepatic or pulmonary disease, peripheral vascular disease, previous cardiac surgery, emergency surgery, reopening surgeries, surgeries requiring a deep hypothermic circulatory arrest.

• Preoperative use of inotropes or vasopressors.

• Perioperative use of diuretics.

• Perioperative episode of CPR.

• Diabetic patients.

• Preoperative hemoglobin level less than 12 mg/dl.

• Hematological disorders.

• Morbidly obese patients.