The Effect of High Single Dose of Dexamethasone in Prevention of Post-operative Acute Kidney Injury in Cardiac Surgeries Requiring Cardiopulmonary Bypass

NCT06783634 | Recruiting Phase 1 DMC

• 1 other identifier: FMASU MS117/2024
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the current study is to assess the effect of intra operative single high dose dexamethasone (1 mg/kg) in decreasing the incidence of post-operative acute kidney injury after cardiac surgeries with cardiopulmonary bypass

Conditions

Acute Kidney Injury After Adult Cardiac Surgery

Outcome Measures

Primary Outcomes (1)

• postoperative acute kidney injury

  Measure the incidence of occurrence of postoperative acute kidney injury in each group of the patients included in the study.

  7 days

Study Arms (2)

Control group :

PLACEBO COMPARATOR

Group 1 (Control group) will receive normal saline as a placebo.

Drug: Placebo

dexamethasone group

ACTIVE COMPARATOR

Group 2 (dexamethasone group) single intra venous high dose of dexamethasone 1mg/kg with maximum dose of 100 mg.

Drug: Dexamethasone

Interventions

Dexamethasone DRUG

Group 2 (dexamethasone group) single intra venous high dose of dexamethasone 1mg/kg with maximum dose of 100 mg.

dexamethasone group

Placebo DRUG

Group 1 (Control group) will receive normal saline as a placebo.

Control group :

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 30-65 years.
• Sex: Both sex.
• Patients with American Society of Anesthesiologists (ASA) score III - IV.
• Patients who were scheduled for any type of elective cardiac surgical procedure requiring cardiopulmonary bypass

You may not qualify if:

• Declining to give written informed consent.
• History of allergy to the medications used in the study.
• Emergent or planned off-pump procedure
• Diabetic patients.
• Patients with recent history of AKI, or have any renal deterioration as GFR \< 80 ml/min./1.73/m2
• Patients scheduled for urgent cardiac surgery.
• Patients scheduled for ascending aortic surgery inducing deep hypothermic total circulatory arrest.
• Patients on high doses of inotropes and/or vasopressors.
• Patients with high drain(s) in the first 6 hours postoperatively.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, 11111, Egypt

RECRUITING

MeSH Terms

Interventions

Dexamethasone

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Nourhan E Abdellatif, MBBCH

  Anesthesia resident Ain Shams University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

nourhan E Abdellatif, MBBCH

CONTACT

+01145544757; noura.elsawy961@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2025
• First Posted: January 20, 2025
• Study Start: February 1, 2025
• Primary Completion: March 25, 2025
• Study Completion: May 30, 2025
• Last Updated: January 20, 2025

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

EG (1)