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

NCT05375188 | Completed Phase 2 FDA Drug

• 1 other identifier: ERC- 66/2021
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

• Post CABG Acute Kidney Injury at 48 hours

  Serum Creatinine (milligram/decilitre) as Kidney Disease Improving Global Outcomes criteria

  up to 48 hours post operatively

Secondary Outcomes (5)

• Aortic Cross Clamp Time

  within 2 hours

• CPB Time

  within 4 hours

• Time of Surgery

  within 8 hours

• ICU stay

  up to 48 hours

• Amount of Urine

  up to 48 hours

Study Arms (2)

Group D

EXPERIMENTAL

Dexmedetomidine was given as an infusion of 0.4 μg/kg/h from induction of anesthesia for 24 hours.

Drug: Dexmedetomidine

Group C

PLACEBO COMPARATOR

Equal volume of normal saline.

Drug: Normal Saline

Interventions

Dexmedetomidine DRUG

DOSAGE FORM: IV Infusion DOSAGE: 0.4 mcg/kg/hr

Also known as: sedatives (Precedex)

Group D

Normal Saline DRUG

DOSAGE FORM: IV Infusion DOSAGE: Equal Volume

Also known as: crystalloid fluid

Group C

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ages ranged between 18 and 65 years.
• Patients undergoing isolated coronary artery bypass grafting.
• Class II and III ASA physical status.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Cardiovascular Diseases, Pakistan: lead

Study Sites (1)

NICVD Karachi

Karachi, Sindh, 75100, Pakistan

Location

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Dexmedetomidine; Hypnotics and Sedatives; Saline Solution

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Haris T Chohan

  NICVD Karachi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post Fellow

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

Study Record Dates

• First Submitted: April 30, 2022
• First Posted: May 16, 2022
• Study Start: August 1, 2021
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: May 16, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)