Intraoperative Dexmedetomidine and Coronary Artery Bypass Graft Surgery

NCT06378827 | Recruiting Phase 2

• 1 other identifier: 418-1/2
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Kidney Injury

Outcome Measures

Primary Outcomes (3)

• Indicator of renal function

  The primary objective of the study will be to monitor serum creatinine (µmol/L) and compare between groups. The changes of all these values in relation to the basal values will be monitored in order to determine when the greatest changes in the serum creatinine values occur.

  5 days

• An early biomarker of kidney injury

  The primary objective of the study will be to monitor serum cystatin C (mg/L) and compare between groups. The changes of all these values in relation to the basal values will be monitored in order to determine when the greatest changes in the serum cystatin C values occur.

  2 days

• The change of inflammatory markers

  The change of inflammatory marker IL-6 (pg/mL) in relation to basal values is also one of the primary goals of the research. IL-6 will be checked on the first postoperative day, when the inflammatory response is most pronounced.

  24 hours

Secondary Outcomes (2)

• Length of postoperative mechanical ventilation

  24 hours

• Length of stay in the intensive care unit

  3 days

Study Arms (2)

Experimental

EXPERIMENTAL

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.

Drug: Dexmedetomidine

Control

PLACEBO COMPARATOR

Patients in the control group will receive the same volume of saline solution.

Drug: Dexmedetomidine

Interventions

Dexmedetomidine DRUG

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.

Control; Experimental

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• Emergency coronary artery bypass graft surgery
• Chronic renal failure with eGFR \<60 ml/min/1.73m2
• Left ventricular ejection fraction \<30%
• nd 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

Sponsors & Collaborators

• University of Novi Sad: lead

Study Sites (1)

University of Novi Sad, Faculty of Medicine

Novi Sad, 21000, Serbia

RECRUITING

Related Publications (1)

• Zdravkovic R, Vickovic S, Preveden M, Drobnjak V, Lukic-Sarkanovic M, Miljevic IB, Tatic M, Tubic T, Videnovic N, Mladenovic N, Komazec N, Dracina N, Jerkovic M, Djokovic A, Jakovljevic A, Kostic A, Mehmedi E, Redzek A. Effect of Continuous Intraoperative Dexmedetomidine on Interleukin-6 and Other Inflammatory Markers After Coronary Artery Bypass Graft Surgery: A Randomized Controlled Trial. Medicina (Kaunas). 2025 Apr 24;61(5):787. doi: 10.3390/medicina61050787.

  PMID: 40428745 DERIVED

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Dexmedetomidine

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 Study Contacts

Ranko Zdravkovic

CONTACT

+381654674620; ranko.zdravkovic@mf.uns.ac.rs

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 13, 2024
• First Posted: April 23, 2024
• Study Start: April 3, 2024
• Primary Completion: July 1, 2024
• Study Completion: October 1, 2024
• Last Updated: April 23, 2024

Record last verified: 2024-04

Locations

SE (1)