RightFit
RecruitingPhase 2

Prevent Cardiac Surgery Associated AKI Trial

Efficacy of Mitochondrial Directed Therapy in Prevention of Cardiac Surgery Associated AKI Prevent Cardiac Surgery Associated AKI Trial (Prevent CSA-AKI Trial)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 70 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 1 week
  • Procedures mentioned: Urine samples

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether coenzyme Q10 (CoQ10) and glutathione help prevent sudden kidney injury after planned heart surgery using a heart-lung machine. It is for adults ages 18–70 who meet a kidney function requirement. Patients receive either the study drugs or a placebo (no active drug), starting the day before surgery and continuing during their hospital stay for up to one week.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18–70 years old.
  • You are having planned heart surgery using a heart-lung machine.
  • Your GFR, a measure of how well your kidneys filter blood, is at least 45 ml/min.

Who can't join

  • Your GFR, a measure of kidney function, is below 45 ml/min.
  • You have only one kidney.
  • You have had a kidney transplant.
  • You are pregnant.
  • You are allergic to CoQ10.
  • You are allergic to glutathione.
  • You are allergic to cellulose.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (1)

DC