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Prevent Cardiac Surgery Associated AKI Trial

NCT06620523 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 242

Last updated 2025-10-08

No results posted yet for this study

Summary

Prevent CSA-AKI (Cardiac Surgery Associated Acute Kidney Injury) trial is a double blinded randomized controlled trial, 242 patients undergoing elective cardiopulmonary bypass surgery (CPB)will either receive a placebo or daily 1200 mg of Co enzyme Q10 (CoQ10) and 1000 mg of Glutathione (GSH), the first dose will be given the day before surgery and continues while admitted up to 1 week. Blood and urine samples will be collected. Adverse events related to the study drugs will be collected.

Conditions

Interventions

DRUG

CoQ10 1200 mg orally with Glutathione 1000 mg orally

This is the intervention to assess efficacy of CoQ10 and Glutathione in prevention of cardiac surgery associated acute kidney injury

DRUG

Group B: Placebo CoQ10 orally and Placebo Glutathione orally

A placebo to exactly match the CoQ10 will be made with white gelatin empty capsules containing cellulose AND a placebo to exactly match the L-Glutathione will be made with white gelatin empty capsules containing cellulose.

Sponsors & Collaborators

  • George Washington University

    lead OTHER

Principal Investigators

  • Yoosif Abdalla, MD · George Washington University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-18
Primary Completion
2027-06-17
Completion
2028-06-17
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06620523 on ClinicalTrials.gov