CoQ10 + Glutathione for Preventing Kidney Failure After Heart Surgery
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: George Washington University
Prior Safety Data
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.
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.
13578How 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.
23578What 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.
23456Will 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.
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 between 18 and 70 years old.
I am scheduled for elective heart-lung machine surgery.
My kidney function is normal or only mildly reduced.
Exclusion Criteria
I have only one kidney.
I have had a kidney transplant.
My kidney function is reduced with a GFR less than 45 ml/min.
Participant Groups
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.
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.
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
George Washington University HospitalWashington, United States
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Who is running the clinical trial?
George Washington UniversityLead Sponsor
References
Coenzyme Q10: the prophylactic effect on low cardiac output following cardiac valve replacement. [2019]A randomized, prospective study of the effectiveness of preoperative administration of coenzyme Q10 on the prophylaxis of postoperative low cardiac output state was performed in 50 patients with acquired valvular diseases necessitating valve replacement. There were 25 patients in the treatment group and 25 in the control group. Patients in the treatment group received 30 to 60 mg of coenzyme Q10 orally for six days before operation. Preoperative clinical variables, operative procedures, total cardiopulmonary bypass time, and aortic cross-clamping time were similar for the two groups. Postoperatively, mild to severe low cardiac output state developed in 28 of 50 patients (56%) and necessitated the administration of considerable amounts of inotropic agent. The treatment group showed a significantly lower incidence of low cardiac output state during the recovery period than the control group (p less than 0.05). These results suggest that preoperative administration of coenzyme Q10 will increase the tolerance of human hearts to ischemia during aortic cross-clamping.
Salutary effect of reduced glutathione on renal function in coronary artery bypass operation. [2013]Renal dysfunction and acute renal failure are serious complications of open heart operations. Previous reports have suggested beneficial effects of exogenous glutathione for preservation of renal function after ischemic renal injury. We prospectively studied the effect of perioperative administration of glutathione on renal function in patients who underwent coronary artery bypass operation.
Protection by coenzyme Q10 from myocardial reperfusion injury during coronary artery bypass grafting. [2019]To evaluate the effect of coenzyme Q10 in reducing postoperative cardiac complications after ischemia and reperfusion, we randomly divided 40 patients undergoing elective coronary artery bypass into two groups: patients in group 1 received coenzyme Q10 (150 mg/day) for 7 days before operation, and those in group 2 were the control group. Concentrations of thiobarbituric acid-reactive substances (malondialdehyde), conjugated dienes, and cardiac isoenzymes of creatine kinase were measured in samples from both arterial and coronary sinus sites. Serial sampling was performed 5 minutes after heparin administration, at 10 and 30 minutes during cardiopulmonary bypass, 15 and 30 minutes after aortic cross-clamp removal, and 5 minutes after protamine administration. The concentrations of malondialdehyde, conjugated dienes, and creatine kinase in group 1 were significantly lower than those in group 2. The decrease in plasma malondialdehyde concentrations correlated positively with the decrease in creatine kinase levels in the coronary sinus. The treatment group showed a significantly lower incidence of ventricular arrhythmias during the recovery period than did the control group (p
N-acetylcysteine to ameliorate acute renal injury in a rat cardiopulmonary bypass model. [2013]Oxidative stress and systemic inflammation response contribute to acute renal injury post cardiac surgery. We hypothesized that administration of the antioxidant N-acetylcysteine would be beneficial to renal function after cardiopulmonary bypass in a rat model.
Targeting oxidative stress in surgery: effects of ageing and therapy. [2021]In the current era cardiac surgeons are being called upon to operate upon older, sicker patients. The effect is to augment oxidative stress and increase the rate of post-operative complications and ultimately mortality. We have developed antioxidant-based pre-treatment regimes initially based on coenzyme Q(10). A randomised trial of coenzyme Q(10) in elective cardiac surgery patients demonstrated augmented plasma and cardiac mitochondrial membrane coenzyme Q(10) content, improved mitochondrial respiration and increased myocardial tolerance of oxidative stress. The addition of omega-3 polyunsaturated fatty acids, alpha-lipoic acid, selenium and magnesium orotate in a second clinical trial, improved post-operative recovery with demonstrable reductions in myocardial damage, rate of atrial fibrillation and length of hospital stay. Finally we performed a pilot study of this combined metabolic therapy regimen to which we added preoperative physical exercise and mental stress reduction with indications of further improvements in post-operative recovery. We conclude that simultaneously targeting a number of key deficiencies with a metabolic formulation prior to surgery results in peri- and post-operative clinical and economic benefits.
N-acetylcysteine to reduce renal failure after cardiac surgery: a systematic review and meta-analysis. [2018]To assess the effect of N-acetylcysteine (NAC) on acute renal failure and important clinical outcomes after cardiac surgery.
Prophylactic treatment with coenzyme Q10 in patients undergoing cardiac surgery: could an antioxidant reduce complications? A systematic review and meta-analysis. [2018]Coenzyme Q10 (CoQ10) is a lipid-soluble antioxidant that could have beneficial effects in patients undergoing cardiac surgery with cardiopulmonary bypass. There is no clear evidence about its clinical effects or a systematic review published yet. We aimed to conduct a systematic review and meta-analysis of the literature to elucidate the role of coenzyme Q10 in preventing complications in patients undergoing cardiac surgery with cardiopulmonary bypass. We searched the PubMed Database using the following keywords: Coenzyme Q10, ubiquinone, ubiquinol, CoQ10, Heart Surgery, Cardiac surgery. Articles were systematically retrieved, selected, assessed and summarized for this review. We performed separate meta-analyses for different outcomes (inotropic drug requirements after surgery, incidence of ventricular arrhythmias and atrial fibrillation, cardiac index 24 h after surgery and hospital stay), estimating pooled odds ratios (ORs) or mean differences of the association of CoQ10 administration with the risk of these outcomes. Eight clinical trials met our inclusion criteria. Patients with CoQ10 treatment were significantly less likely to require inotropic drugs after surgery {OR [95% confidence interval (CI) 0.47 (0.27-0.81)]}, and to develop ventricular arrhythmias after surgery [OR (95% CI) 0.05 (0.01-0.31)]. However, CoQ10 treatment was not associated with Cardiac index 24 h after surgery [mean difference (95% CI) 0.06 (-0.30 to 0.43)], hospital stay (days) [mean difference (95% CI) -0.61 (-4.61 to 3.39)] and incidence of atrial fibrillation [OR (95% CI) 1.06 (0.19-6.04)]. Since none of the clinical trials included in this review report any adverse effects associated to CoQ10 administration, and coenzyme Q10 has been demonstrated to be safe even at much higher doses in other studies, we conclude that CoQ10 should be considered as a prophylactic treatment for preventing complications in patients undergoing cardiac surgery with cardiopulmonary bypass. However, better quality randomized, controlled trials are needed to clarify the role of CoQ10 in patients undergoing cardiac surgery with cardiopulmonary bypass.
A systematic review for the efficacy of coenzyme Q10 in patients with chronic kidney disease. [2022]The effects of coenzyme Q10 (CoQ10) supplementation in chronic kidney disease (CKD) patients remain controversial.