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Trial · Interventional

RecruitingPhase 2Registry data

Prevent Cardiac Surgery Associated AKI Trial

NCTNCT06620523 (opens ClinicalTrials.gov in a new tab)Other idNCR224635
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Overview

Status
Recruiting
Phase
Phase 2
Enrollment
242 participants (estimated)
Sponsor
George Washington University · Other
Design
Randomized · Triple masking
Countries
1 country

United States

Start
18 Jul 2024
Primary completion
17 Jun 2027 (estimated)
Completion
17 Jun 2028 (estimated)
First posted
1 Oct 2024
Last update posted
8 Oct 2025
Conditions
Renal Failure · Coronary Artery Disease · Surgery · Surgery-Complications

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202420252026202720282029
  1. Ph 2

    Prevent Cardiac Surgery Associated AKI Trial

    NCT06620523

    18 Jul 2024 to est. 17 Jun 2028

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • CoQ10 1200 mg orally with Glutathione 1000 mg orallyDrug
  • Group B: Placebo CoQ10 orally and Placebo Glutathione orallyDrug

Arms2

  • Active comparator

    Group A: CoQ10 1200 mg orally with Glutathione 1000 mg orally

    White-colored CoQ10 400 mg capsules will be dispensed AND White colored L-Glutathione 500 mg capsules will be dispensed.

  • Placebo comparator

    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.

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. AKI incidence reduction

    Time frame · 28 days

    Registry description

    Reduction of cardiac surgery associated acute kidney injury

  2. AKI incidence reduction

    Time frame · 90 days

    Registry description

    Reduction of cardiac surgery associated acute kidney injury

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 70 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Adult 18-70 years of age * Undergoing elective CPB (Cardiopulmonary Bypass) surgery * Baseline GFR (Glomerular Filtration Rate) ≥45 ml/min Exclusion Criteria: * GFR (Glomerular Filtration Rate) \<45 ml/min * Solitary kidney * Status post-kidney transplant * Pregnant women * Allergy to CoQ10 * Allergy to Glutathione * Allergy to Cellulose

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