CoQ10 + Glutathione for Preventing Kidney Failure After Heart Surgery

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

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the treatment CoQ10 and Glutathione for preventing kidney failure after heart surgery?

Research shows that Coenzyme Q10 can improve heart function and reduce complications after heart surgery, while Glutathione has been suggested to help protect kidney function during similar procedures. ^{1 2 3 4 5}

Is CoQ10 safe for use in humans?

CoQ10 has been shown to be safe in humans, even at higher doses, with no adverse effects reported in clinical trials for cardiac surgery patients. ^{1 2 6 7 8}

How does the treatment with CoQ10 and Glutathione differ from other treatments for preventing kidney failure after heart surgery?

This treatment is unique because it combines Coenzyme Q10, an antioxidant that may reduce heart complications, with Glutathione, which has shown potential in preserving kidney function after heart surgery. Unlike standard treatments, this combination targets oxidative stress, a key factor in surgery-related complications, potentially offering a novel approach to protect both heart and kidney functions. ^{1 2 5 6 7}

Research Team

Yoosif Abdalla, MD

Principal Investigator

George Washington University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Targeting oxidative stress in surgery: effects of ageing and therapy. [2021]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Protection by coenzyme Q10 from myocardial reperfusion injury during coronary artery bypass grafting. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

N-acetylcysteine to ameliorate acute renal injury in a rat cardiopulmonary bypass model. [2013]

4. United States pubmed.ncbi.nlm.nih.gov

N-acetylcysteine to reduce renal failure after cardiac surgery: a systematic review and meta-analysis. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Salutary effect of reduced glutathione on renal function in coronary artery bypass operation. [2013]

6. England 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. [2018]

7. Netherlands pubmed.ncbi.nlm.nih.gov

A systematic review for the efficacy of coenzyme Q10 in patients with chronic kidney disease. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Coenzyme Q10: the prophylactic effect on low cardiac output following cardiac valve replacement. [2019]