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Clinical trial

The Effect of Intraoperative Dexmedetomidine on Renal Function After Coronary Artery Bypass Graft Surgery

ID
Name
418-1/2
Description
This is a prospective randomized clinical trial designed to determine the effect of intraoperative dexmedetomidine administration on renal function after coronary artery bypass graft surgery.
Trial arms
Trial start
2024-04-03
Estimated PCD
2024-07-01
Trial end
2024-10-01
Status
Recruiting
Phase
Early phase I
Treatment
Dexmedetomidine
Dexmedetomidine solution will be prepared by diluting one ampoule of dexmedetomidine (200µg/2ml) with 48 ml of saline solution to obtain a dexmedetomidine solution of 4µg/ml. Patients from the experimental group will receive a continuous infusion of dexmedetomidine at a dose of 0.5 µg/kg/h, until the end of the operation.
Arms:
Control, Experimental
Size
100
Primary endpoint
Indicator of renal function
5 days
An early biomarker of kidney injury
2 days
The change of inflammatory markers
24 hours
Eligibility criteria
Inclusion Criteria: * Elective coronary artery bypass graft surgery * Age over 18 years * ASA score 3 or 4 * Voluntary consent of the patient to participate in the research Exclusion Criteria: * Emergency coronary artery bypass graft surgery * Chronic renal failure with eGFR \<60 ml/min/1.73m2 * Left ventricular ejection fraction \<30% * 2nd or 3rd degree atrioventricular block * Use of nephrotoxic agents such as aminoglycoside antibiotics or contrast agents within the last 48 hours * Previous heart surgery or kidney surgery * Allergy to dexmedetomidine
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}
Updated at
2024-04-23

1 organization

1 product

1 indication

Organization
University of Novi Sad
Product
Dexmedetomidine
Indication
Acute Kidney Injury