NCT06620523

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
242

participants targeted

Target at P75+ for phase_2

Timeline
26mo left

Started Jul 2024

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress46%
Jul 2024Jun 2028

Study Start

First participant enrolled

July 18, 2024

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

July 30, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 1, 2024

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 17, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 17, 2028

Last Updated

October 8, 2025

Status Verified

October 1, 2025

Enrollment Period

2.9 years

First QC Date

July 30, 2024

Last Update Submit

October 3, 2025

Conditions

Renal FailureCoronary Artery DiseaseSurgerySurgery-Complications

Keywords

cardiac surgerycritical care medicineanesthesiologynephrologycardiopulmonary bypassrenal failureakisupplement

Outcome Measures

Primary Outcomes (2)

  • AKI incidence reduction

    Reduction of cardiac surgery associated acute kidney injury

    28 days

  • AKI incidence reduction

    Reduction of cardiac surgery associated acute kidney injury

    90 days

Study Arms (2)

Group A: CoQ10 1200 mg orally with Glutathione 1000 mg orally

ACTIVE COMPARATOR

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

Drug: CoQ10 1200 mg orally with Glutathione 1000 mg orally

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.

Drug: Group B: Placebo CoQ10 orally and Placebo Glutathione orally

Interventions

CoQ10 1200 mg orally with Glutathione 1000 mg orallyDRUG

This is the intervention to assess efficacy of CoQ10 and Glutathione in prevention of cardiac surgery associated acute kidney injury

Group A: CoQ10 1200 mg orally with Glutathione 1000 mg orally
Group B: Placebo CoQ10 orally and Placebo Glutathione orallyDRUG

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.

Group B: Placebo CoQ10 orally and Placebo Glutathione orally

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult 18-70 years of age
  • Undergoing elective CPB (Cardiopulmonary Bypass) surgery
  • Baseline GFR (Glomerular Filtration Rate) ≥45 ml/min

You may not qualify if:

  • GFR (Glomerular Filtration Rate) \<45 ml/min
  • Solitary kidney
  • Status post-kidney transplant
  • Pregnant women
  • Allergy to CoQ10
  • Allergy to Glutathione
  • Allergy to Cellulose

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

George Washington University Hospital

Washington D.C., District of Columbia, 20037, United States

RECRUITING

MeSH Terms

Conditions

Renal InsufficiencyCoronary Artery Disease

Interventions

coenzyme Q10Glutathione

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesCoronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

OligopeptidesPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Yoosif Abdalla, MD

    George Washington University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eduard Shaykhinurov, MS

CONTACT

2028234259eshaykhinurov@mfa.gwu.edu

Yoosif Abdalla, MD

CONTACT

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
Blinded: study team, including principal investigator, sub-investigators, study coordinators, hospital pharmacy and medical students. Patient is also blinded. Unblinded: investigational drug pharmacists, investigational drug pharmacy technicians, nurses administering medication
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 30, 2024

First Posted

October 1, 2024

Study Start

July 18, 2024

Primary Completion (Estimated)

June 17, 2027

Study Completion (Estimated)

June 17, 2028

Last Updated

October 8, 2025

Record last verified: 2025-10

Locations

US(1)