CoQ10 + Glutathione for Preventing Kidney Failure After Heart Surgery

Recruiting at 1 trial location

Overseen By Yoosif Abdalla, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: George Washington University

Disqualifiers: Low GFR, Solitary kidney, Kidney transplant, Pregnancy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 1 week

242 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if Coenzyme Q10 and Glutathione, both dietary supplements, can prevent kidney damage after heart surgery. Researchers are focusing on patients undergoing planned heart surgery involving a heart-lung machine. Participants will receive either the actual supplements or a placebo, a pill that looks the same but contains no active ingredients, to compare effects. Individuals scheduled for this type of surgery with normal kidney function might be suitable for this study. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that Coenzyme Q10 and Glutathione are likely to be safe for humans?

Research has shown that Coenzyme Q10 (CoQ10) and Glutathione are generally safe for people. In previous studies, patients who underwent heart surgery took CoQ10 without experiencing negative effects, indicating that the treatment is usually well-tolerated, even in larger amounts.

CoQ10 has also been found to protect kidneys from damage caused by certain medications, further supporting its safety and effectiveness. Overall, current research suggests that using CoQ10 and Glutathione together is safe. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about using Coenzyme Q10 (CoQ10) and Glutathione to prevent kidney failure after heart surgery because these substances offer a fresh approach to protecting the kidneys. Unlike current treatments, which often focus on managing symptoms or complications after they arise, CoQ10 and Glutathione are antioxidants that work to prevent damage at a cellular level by reducing oxidative stress. This proactive method could potentially safeguard the kidneys before significant harm occurs, offering a new avenue of protection compared to traditional care. Additionally, the use of natural compounds like CoQ10 and Glutathione is appealing due to their potential for fewer side effects, making them a promising alternative to conventional medications.

What evidence suggests that CoQ10 and Glutathione might be an effective treatment for preventing kidney failure after heart surgery?

Research has shown that Coenzyme Q10 (CoQ10) and Glutathione might protect kidneys during heart surgery. One study found that CoQ10 improved cellular energy production and helped the body manage surgical stress. Another study discovered that CoQ10 reduced kidney damage by lowering harmful oxidative stress. This trial will test the combination of CoQ10 and Glutathione, which might offer additional protection against kidney damage during and after heart surgery. Participants in this trial will receive either the active combination of CoQ10 and Glutathione or a placebo. ^{1 2 5 6 7}

Who Is on the Research Team?

Yoosif Abdalla, MD

Principal Investigator

George Washington University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am scheduled for elective heart-lung machine surgery.

My kidney function is normal or only mildly reduced.

Exclusion Criteria

Pregnant women

Allergy to CoQ10

Allergy to Glutathione

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either placebo or daily 1200 mg of CoQ10 and 1000 mg of Glutathione starting the day before surgery and continuing while admitted up to 1 week.

1 week

Daily visits while admitted

Follow-up

Participants are monitored for safety and effectiveness after treatment, with blood and urine samples collected.

90 days

What Are the Treatments Tested in This Trial?

Interventions

• Coenzyme Q10 and Glutathione

Trial Overview

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.

How Is the Trial Designed?

Group I: Group A: CoQ10 1200 mg orally with Glutathione 1000 mg orally Active Control 1 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 orally Placebo Group 1 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.

Who Is Running the Clinical Trial?

George Washington University

Lead Sponsor

Trials

263

Recruited

476,000+

Published Research Related to This Trial

Coenzyme Q10 (CoQ10) significantly reduces the need for inotropic drugs and the incidence of ventricular arrhythmias in patients undergoing cardiac surgery with cardiopulmonary bypass, based on a systematic review of 8 clinical trials.

CoQ10 treatment was found to be safe, with no reported adverse effects, suggesting it could be a beneficial prophylactic treatment for preventing complications during cardiac surgery, although further high-quality studies are needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prophylactic treatment with coenzyme Q10 in patients undergoing cardiac surgery: could an antioxidant reduce complications? A systematic review and meta-analysis. de Frutos, F., Gea, A., Hernandez-Estefania, R., et al.[2018]

In a study of 40 patients undergoing coronary artery bypass surgery, those who received coenzyme Q10 (150 mg/day for 7 days) showed significantly lower levels of harmful substances like malondialdehyde and creatine kinase, indicating reduced oxidative stress and cardiac damage.

Patients treated with coenzyme Q10 experienced fewer ventricular arrhythmias during recovery and required a lower mean dosage of dopamine to maintain stable heart function, suggesting that coenzyme Q10 may provide protective benefits during cardiac surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protection by coenzyme Q10 from myocardial reperfusion injury during coronary artery bypass grafting. Chello, M., Mastroroberto, P., Romano, R., et al.[2019]

A randomized trial showed that pre-treatment with coenzyme Q(10) in elective cardiac surgery patients improved mitochondrial function and increased tolerance to oxidative stress, which is crucial for older, sicker patients undergoing surgery.

Combining coenzyme Q(10) with omega-3 fatty acids, alpha-lipoic acid, selenium, and magnesium orotate led to better post-operative recovery, reducing myocardial damage, atrial fibrillation rates, and hospital stay length, indicating a comprehensive approach to enhance surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeting oxidative stress in surgery: effects of ageing and therapy. Pepe, S., Leong, JY., Merwe, JV., et al.[2021]

Coenzyme Q10 (CoQ10) supplementation in chronic kidney disease (CKD) patients showed significant reductions in markers of oxidative stress and inflammation, specifically lowering malonaldehyde and high-sensitivity C-reactive protein levels.

CoQ10 supplementation also improved glucose metabolism, evidenced by reductions in HbA1c and increases in QUICKI scores, although it did not affect lipid profiles such as total cholesterol or triglycerides.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review for the efficacy of coenzyme Q10 in patients with chronic kidney disease. Xu, Y., Yang, G., Zuo, X., et al.[2022]

In a study of 50 patients undergoing valve replacement surgery, preoperative administration of coenzyme Q10 significantly reduced the incidence of postoperative low cardiac output state compared to a control group, indicating its potential efficacy in improving heart tolerance during surgery.

The treatment group, which received 30 to 60 mg of coenzyme Q10 for six days before surgery, experienced a lower need for inotropic agents postoperatively, suggesting that coenzyme Q10 may enhance cardiac function during recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coenzyme Q10: the prophylactic effect on low cardiac output following cardiac valve replacement. Tanaka, J., Tominaga, R., Yoshitoshi, M., et al.[2019]

In a study involving male Sprague-Dawley rats, the antioxidant N-acetylcysteine was found to significantly preserve renal function after cardiopulmonary bypass, with improvements observed in kidney health and function at doses of 200 and 500 mg/kg.

N-acetylcysteine treatment reduced oxidative stress and systemic inflammation markers, such as malondialdehyde and tumor necrosis factor alpha, indicating its potential as a protective agent against acute renal injury post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

N-acetylcysteine to ameliorate acute renal injury in a rat cardiopulmonary bypass model. Zhu, J., Yin, R., Shao, H., et al.[2013]

In a study of 10 patients undergoing coronary artery bypass surgery, perioperative administration of glutathione significantly preserved renal function compared to a placebo, as indicated by better urine volume and creatinine clearance.

Glutathione treatment resulted in improved renal hemodynamics, evidenced by lower mean arterial pressure and systemic vascular resistance, suggesting it may help protect against renal dysfunction during and after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Salutary effect of reduced glutathione on renal function in coronary artery bypass operation. Amano, J., Suzuki, A., Sunamori, M.[2013]

A systematic review of seven randomized controlled trials involving 1000 patients found that N-acetylcysteine (NAC) did not improve kidney function or reduce mortality and other serious complications after cardiac surgery.

Patients treated with NAC experienced a small but significant increase in postoperative blood loss, suggesting that NAC may not be a safe option for renal protection in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

N-acetylcysteine to reduce renal failure after cardiac surgery: a systematic review and meta-analysis. Naughton, F., Wijeysundera, D., Karkouti, K., et al.[2018]

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Is High-Dose Ubiquinone Therapy Before Cardiac Surgery ...

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