Prevent Cardiac Surgery Associated AKI Trial

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
George Washington University
Study ID
NCT06620523
Phase
PHASE2
Status
Recruiting
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Conditions

  • Coronary Artery Disease
  • Renal Failure
  • Surgery
  • Surgery-Complications

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • CoQ10 1200 mg orally with Glutathione 1000 mg orally — DRUG
    This is the intervention to assess efficacy of CoQ10 and Glutathione in prevention of cardiac surgery associated acute kidney injury
  • Group B: Placebo CoQ10 orally and Placebo Glutathione orally — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jul 18, 2024
Status verified
Oct 2025
Primary completion
Jun 17, 2027
Completion
Jun 17, 2028

Study Design

Enrollment
242 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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 Outcome Measure

AKI incidence reduction [ Time Frame: 28 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
George Washington University HospitalWashington D.C.District of Columbia20037
Eduard Shaykhinurov
[email protected]
202-823-4259
Yoosif Abdalla, MD (PRINCIPAL_INVESTIGATOR)

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George Washington University Hospital· Washington D.C., DC

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