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Antioxidant

CoQ10 + Glutathione for Preventing Kidney Failure After Heart Surgery

Phase 2

Recruiting

Led By Yoosif Abdalla, MD

Research Sponsored by George Washington University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adult 18-70 years of age

Undergoing elective CPB (Cardiopulmonary Bypass) surgery

Must not have

Solitary kidney

Status post-kidney transplant

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 28 days

Summary

This trial is testing a new treatment for preventing kidney injury after heart surgery. 242 patients will be randomly assigned to receive either a placebo or a combination of Co enzyme Q10 and Glutathione

Who is the study for?

This trial is for patients with kidney failure and coronary artery disease who are scheduled for elective heart surgery using cardiopulmonary bypass. Participants must be able to take oral medication and provide blood and urine samples.

What is being tested?

The study compares the effects of CoQ10 (1200 mg) plus Glutathione (1000 mg) against placebos in preventing acute kidney injury after cardiac surgery. Patients will receive their assigned treatment from the day before surgery up to one week while hospitalized.

What are the potential side effects?

Potential side effects may include allergic reactions, gastrointestinal issues like upset stomach or diarrhea, and possible interactions with other medications. Close monitoring will identify any adverse events related to CoQ10 or Glutathione.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 70 years old.

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I am scheduled for elective heart-lung machine surgery.

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My kidney function is normal or only mildly reduced.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have only one kidney.

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I have had a kidney transplant.

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My kidney function is reduced with a GFR less than 45 ml/min.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 28 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~28 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

AKI incidence reduction

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Group A: CoQ10 1200 mg orally with Glutathione 1000 mg orallyActive Control1 Intervention

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

Group II: Group B: Placebo CoQ10 orally and Placebo Glutathione orallyPlacebo Group1 Intervention

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.

0 / 6Eligibility criteria met