Skip to content

Evaluating the prescription of short-term and medium-term effects of coenzyme Q?? on the inflammatory system and renal function in patients undergoing open heart surgery

Evaluating the prescription of short-term and medium-term effects of coenzyme Q?? on the inflammatory system and renal function in patients undergoing open heart surgery

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20230218057444N1
Enrollment
41
Registered
2023-03-06
Start date
2023-03-25
Completion date
Unknown
Last updated
2023-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Evaluating the prescription of short-term and medium-term effects of coenzyme Q10 on the inflammatory system and renal function in patients undergoing openheart surgery.

Interventions

Intervention 1: Intervention group: Patients will be divided into two control and intervention groups based on random sampling (permutation blocks). Patients in the intervention group will receive CoQ
until the active coagulation time (ACT) is higher than 480 seconds. . Crystalloid (2000 cc Ringer) and colloid (50 cc albumin) are used to prime the oxygenator in both groups. During CPB, additional h
to reach the ACT target of 80-120. In order to measure and evaluate inflammatory factors, 2 ml of arterial blood samples are taken in three time periods at the beginning of the operation, after cardio

Sponsors

Ghoum University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: The inclusion criteria for all patients over 18 years of age, suffering from coronary artery disease undergoing CABG surgery, is the glomerular filtration rate (GFR) greater than 45ml/min.

Exclusion criteria

Exclusion criteria: current coenzyme Q10 therapy, which has high-risk features that warrant urgent coronary angiography (within 4 hours); the existence of sensitivity to CoQ10, people with kidney failure who need dialysis; Exposure to contrast media in the past 7 days, left ventricular ejection fraction (LVEF) <30, administration of N-acetylcysteine within 48 hours postoperatively, and refusal of consent.

Design outcomes

Primary

MeasureTime frame
Measurement of interleukin-10 and interleukin-6 factorsIn order to evaluate the performance of all three parameters, creatinine level, blood urea nitrogen and glomerular filtration rate (GFR) are checked. Timepoint: Patients in the intervention group will receive CoQ10 tablets, 300 mg, twice a day every 12 hours, in the period of two days before the operation until the time of discharge from the ICU department and sending to the POST ICU department. Patients in the control group will receive the placebo in the same way, that is, from two days before the operation until the time of discharge from the ICU. Anesthesia induction will be done for all patients with sufentanil 2 µg/kg, nesdonal 3 mg/kg and pancuronium 0.1 mg/kg, and anesthesia will be maintained with 0.5-1% isoflurane and during cardiopulmonary bypass with Pancranium 0.1 mg/kg/h, fentanyl 1-2 µg/kg, and midazolam 0.5-1-1 kg/mg are maintained, and all patients will receive heparin 300 u/kg before cardiopulmonary bypass; until the active coagulation time (ACT) is higher than 480 seconds. . Crystalloid (2000 cc Ringer) and colloid (50 cc albumin) are used to prime the oxygenator in both groups. During CPB, additional heparin will be prescribed to reach the target ACT. After completing CPB and disconnecting from the heparin pump, it is neutralized with protamine sulfate 1 mg per 100 units of heparin; to reach the ACT target of 80-120. In order to measure and evaluate inflammatory factors, 2 ml of arterial blood samples are taken in three time periods at the beginning of the operation, after cardio-pulmonary bypass and 24 hours after entering the ICU. Then, the sample is immediately sent to the relevant laboratories to measure interleukin-10 and interleukin-6 factors, and serology tests are measured by the ELISA kit of MabTag GmbH - Germany.In order to evaluate the performance of all three parameters, creatinine level, blood urea nitrogen and glomerular filtration rate (GFR) are checked. In this way, 2 ml of ve

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMotahareh Ghodrati

Ghoum University of Medical Sciences

m.ghodrati87@gmail.com+98 25 3664 1601

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026