Health TrialsbyHealthPanel

Prevent Cardiac Surgery Associated AKI Trial

ConditionsRenal FailureCoronary Artery DiseaseSurgerySurgery-Complications
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorGeorge Washington University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult 18-70 years of age

Undergoing elective CPB (Cardiopulmonary Bypass) surgery

Baseline GFR (Glomerular Filtration Rate) ≥45 ml/min

Disqualifiers

GFR (Glomerular Filtration Rate) <45 ml/min

Solitary kidney

Status post-kidney transplant

Pregnant women

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

242 Participants
are divided into 2 treatment groups
Group A: Group A: CoQ10 1200 mg orally with Glutathione 1000 mg orallyActive comparator 1 intervention
Group B: Group B: Placebo CoQ10 orally and Placebo Glutathione orallyPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

AKI incidence reduction

Reduction of cardiac surgery associated acute kidney injury

Time frame
28 days
2

AKI incidence reduction

Reduction of cardiac surgery associated acute kidney injury

Time frame
90 days

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

George Washington University

Lead sponsor

Source ClinicalTrials.gov
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