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

NCT04919564 | Completed Phase 2 Results DMC

• 2 other identifiers: LB.02.01/VII/533/KEP024/2021NationalCCHK
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Kidney Disease; Cardiac Disease

Keywords

Furosemide; Kidney Dysfunction; Glomerular Filtration Rate

Outcome Measures

Primary Outcomes (7)

• Glomerular Filtration Rate at Baseline

  Glomerular Filtration Rate measured at baseline

  baseline / before induction to anesthesia

• Glomerular Filtration Rate at 12 Hours From Drug Infusion

  Glomerular Filtration Rate measured at 12 hours from the initiation of drug infusion

  12 hours from drug infusion

• Glomerular Filtration Rate at 24 Hours From Drug Infusion

  Glomerular Filtration Rate measured at 24 hours from the initiation of drug infusion

  24 hours after from infusion

• Glomerular Filtration Rate at 48 Hours From Drug Infusion

  Glomerular Filtration Rate measured at 48 hours from the initiation of drug infusion

  48 hours from drug infusion

• Glomerular Filtration Rate at 120 Hours From Drug Infusion

  Glomerular Filtration Rate measured at 120 hours from the initiation of drug infusion

  120 hours from drug infusion

• Therapeutic Dose of Continuous Diuretic Infusion

  number of participants with Therapeutic Dose of Continuous Diuretic Infusion

  28 days (or until hospital discharge)

• Renal Replacement Therapy

  number of participant with Renal Replacement Therapy

  28 days (or until hospital discharge)

Secondary Outcomes (2)

• ICU Length of Stay

  28 days (or until hospital discharge)

• In Hospital Mortality

  28 days (or until hospital discharge)

Study Arms (2)

Furosemide group

EXPERIMENTAL

Continuous furosemide 2 mg/hour for a period of 12 hours begins since anesthetic induction

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

Placebo group

PLACEBO COMPARATOR

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

Drug: NaCl 0.9%

Interventions

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

Furosemide 2 mg/hour infusion for 12 hours since induction

Also known as: Lasix injection

Furosemide group

NaCl 0.9% DRUG

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

Placebo group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cardiovascular Center Harapan Kita Hospital Indonesia: lead

Study Sites (1)

National Cardiovascular Center Harapan Kita Jakarta

Jakarta, 11420, Indonesia

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Heart Diseases

Interventions

Furosemide; Sodium Chloride

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Sulfanilamides; Sulfonamides; Amides; Organic Chemicals; Aniline Compounds; Amines; Sulfones; Sulfur Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Limitations and Caveats

Technical problems with measurement leading to unreliable or uninterpretable data; others attendings decision leading to termination of subject

Results Point of Contact

• Title: Prieta Adriane, MD
• Organization: National Cardiovascular Center Harapan Kita Jakarta

prietaadriane@gmail.com

+62 852-2004-0006

Study Officials

• Bambang Widyantoro, PhD

  National Cardiovascular Center Harapan Kita

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Allocation group was blinded for participants, care provider, and investigators
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 27, 2021
• First Posted: June 9, 2021
• Study Start: May 27, 2021
• Primary Completion: December 31, 2021
• Study Completion: February 28, 2022
• Last Updated: January 5, 2024
• Results First Posted: January 5, 2024

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)