CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 90 enrolled
Drug / intervention
Furosemide in 0.9 % NaCl 100 Mg/100 mL (1 mg/mL) +1 moredrug
Likely dose
Furosemide in 0.9 % NaCl 100 Mg/100 mL (1 mg/mL)from record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04919564
NCT04919564Phase 2Completed

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

National Cardiovascular Center Harapan Kita Hospital Indonesia·interventional·Posted Jun 9, 2021·Updated Jan 5, 2024

In Brief

A Phase 2 clinical trial evaluating Furosemide in 0.9 % NaCl 100 Mg/100 mL (1 mg/mL) and NaCl 0.9% for Chronic Kidney Disease and Cardiac Disease. Completed, enrolled 90 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesIndonesia
Collaborators--

Timeline

Phase 2CompletedFinished
20222023202420252026
First PostedJun 9, 2021
Enrollment StartMay 27, 2021
Primary CompletionDec 31, 2021
Study CompletionFeb 28, 2022
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 5.1 years ago

Interventions

Furosemide in 0.9 % NaCl 100 Mg/100 mL (1 mg/mL)drug

Furosemide 2 mg/hour infusion for 12 hours since induction

NaCl 0.9%drug

NaCl 0.9% 2 cc/hour for a period of 12 hours since anesthetic induction