CompletedPhase 2

Low Dose Continuous Furosemide Effect on Cardiac Surgery Patients With Kidney Dysfunction

Indonesia90 participantsStarted 2021-05-27

Plain-language summary

Chronic kidney disease is an independent risk factor for cardiovascular disease associated with increased mortality rate during cardiac surgery in proportion to the kidney function. Chronic kidney disease is defined by decreased glomerular filtration rate (GFR) as classified by Kidney Disease: Improving Global Outcome (KDIGO). Deterioration of kidney function has a complex and multifactorial pathophysiologic derangement. In order to counter kidney injury associated with cardiac surgery, several pharmacologic and non-pharmacologic interventions have been studied to prevent perioperative deterioration of kidney function. Diuretics as pharmacologic measure are often used post-cardiac surgery to treat fluid overload and managing patient with acute kidney injury by preventing anuria. Loop diuretics (furosemide) may improve renal blood flow, decrease reabsorption in renal tubules, decrease oxygen demand and energy consumption (blocking potassium/sodium/2cloride co-transport in loop of Henle), and prevent hypoxic injury of renal medulla. Low dose continuous furosemide hypothetically has a protective effect on cardiac surgery patients with kidney dysfunction, measured improved glomerular filtration rate, decreased indication for therapeutic furosemide infusion, and decreased need of renal replacement therapy. On the other hand, administration of furosemide is rather harmful in severe kidney dysfunction. Therefore, the objective of this study is to determine the protective effect of low-dose continuous furosemide perioperative in cardiac surgery patients with mild to moderate kidney dysfunction.

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age 18 to 65 years old. * Patient planned with elective cardiac surgery such as CABG, one cardiac valve replacement, one cardiac valve repair or two valves, CABG and replacement/repair one cardiac valve. * Cardiac surgery performed using cardiopulmonary bypass machine. * Patient with mild to moderate kidney dysfunction (GFR 30-89 mL/min/1.73m2) and never got renal replacement therapy before. Exclusion Criteria: * Cardiac ejection fraction \<40%. * Patient with new preoperative acute renal failure by any cause. * Sudden shift in cardiac surgery timing (emergency cardiac surgery or repeated procedure). * Complex cardiac disease associated with intra aortic balloon pump use, replacement of more than two cardiac valves, coronary artery disease with severe valve disease, and patient with pulmonary hypertension, and cardiac surgery procedures for congenital heart disease. * Patient with aortic abnormality, and/or has direct effect on renal artery. * Patients concurrently enrolled in other study with other drugs being studied. * Patient with hemodynamic disturbance caused by hemorrhage, sepsis, anaphylactic, or cardiogenic shock. * Patient refuses to participate in the study.

What they're measuring

Glomerular Filtration Rate at Baseline

Timeframe: baseline / before induction to anesthesia

Glomerular Filtration Rate at 12 Hours From Drug Infusion

Timeframe: 12 hours from drug infusion

Glomerular Filtration Rate at 24 Hours From Drug Infusion

Timeframe: 24 hours after from infusion

Glomerular Filtration Rate at 48 Hours From Drug Infusion

Timeframe: 48 hours from drug infusion

Glomerular Filtration Rate at 120 Hours From Drug Infusion

Timeframe: 120 hours from drug infusion

Therapeutic Dose of Continuous Diuretic Infusion

Timeframe: 28 days (or until hospital discharge)

Renal Replacement Therapy

Timeframe: 28 days (or until hospital discharge)

Trial details

NCT IDNCT04919564

SponsorNational Cardiovascular Center Harapan Kita Hospital Indonesia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-12-31

Results submitted2022-03-09

View on ClinicalTrials.gov More Chronic Kidney Disease trials

Plain-language summary

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Glomerular Filtration Rate at Baseline

Timeframe: baseline / before induction to anesthesia

Glomerular Filtration Rate at 12 Hours From Drug Infusion

Timeframe: 12 hours from drug infusion

Glomerular Filtration Rate at 24 Hours From Drug Infusion

Timeframe: 24 hours after from infusion

Glomerular Filtration Rate at 48 Hours From Drug Infusion

Timeframe: 48 hours from drug infusion

Glomerular Filtration Rate at 120 Hours From Drug Infusion

Timeframe: 120 hours from drug infusion

Therapeutic Dose of Continuous Diuretic Infusion

Timeframe: 28 days (or until hospital discharge)

Renal Replacement Therapy

Timeframe: 28 days (or until hospital discharge)