NCT05375188

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

Completed Phase 2, PHASE3 Last updated 16 May 2022

What this trial tests

Phase 2, PHASE3 trial testing Dexmedetomidine in Acute Kidney Injury in 60 participants. Completed in 31 January 2022.

Timeline

1 August 2021

Primary endpoint
31 January 2022

31 January 2022

Quick facts

Lead sponsor	National Institute of Cardiovascular Diseases, Pakistan
Phase	Phase 2, PHASE3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	60
Start date	1 August 2021
Primary completion	31 January 2022
Estimated completion	31 January 2022
Sites	1 location across Pakistan

Drugs / interventions tested

• Dexmedetomidine (dexmedetomidine) — full drug profile →
• Normal Saline

Conditions studied

• Acute Kidney Injury — all drugs for Acute Kidney Injury →

Sponsor

National Institute of Cardiovascular Diseases, Pakistan

Who can join

Adults 18 to 65, any sex, with Acute Kidney Injury. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.