Prevent Cardiac Surgery Associated AKI Trial

What Was Tested

The trial (phase 2) is built around Glutathione.

Blood and urine samples will be collected.

Adverse events related to the study drugs will be collected.

It had two arms (groups): one (active comparator) and Group B: Placebo CoQ10 orally and Placebo Glutathione orally (placebo comparator).

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.

The registry classes the interventions as drug.

More on the Plan

UmtDNA level correlated with renal function recovery but not with AKI severity following cardiac surgery.

Co Q10 levels were found to be low in critically ill patients, lower levels found in post cardiac arrest with correlation poor neurological outcome and higher mortality.

Despite the accumulating evidence on the relevance of mitochondrial dysfunction in AKI initiation and progression and the crucial role mitochondrial therapies such as Co Q10 \& Glutathione would play in renal protection and recovery, human data in this field are very limited.

Glutathione S-transferases (GST) are a diverse group of phase II detoxification enzymes that works as a scavenger through conjugation of glutathione to a wide variety of electrophiles and reactive oxygen species.

Who Took Part

The registry lists 242 planned participants were the target.

It was open to people of any sex aged from 18 years up to 70 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Adult 18-70 years of age. Undergoing elective CPB (Cardiopulmonary Bypass) surgery.

The full record lists 3 inclusion and 7 exclusion criteria; among the exclusions: solitary kidney; status post-kidney transplant; pregnant women.

How the Study Was Run

Design: randomized, parallel-group and triple-blind.

The participants were allocated by chance, so the Glutathione group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received Glutathione.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2024-07-18 with completion listed for 2027-06-17.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Glutathione in 242 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Glutathione compound page, all human trials.