- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04919564
Low Dose Continuous Furosemide Effect on Cardiac Surgery Patients With Kidney Dysfunction
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study was a double-blind randomized controlled trial to determine the protective effect of low-dose continuous furosemide perioperative in cardiac surgery patients with mild to moderate kidney dysfunction. Ethical clearance for the study was approved by Institutional Review Board of National Cardiovascular Center Harapan Kita. Patients eligible for the study was recruited and written informed consent was obtained after clear explanation of the study. Allocation of furosemide and control group was done using simple computer randomization by staff who was not involved in the study. Furosemide infusion and normal saline was prepared by independent pharmacist blinded to the study. Furosemide solution was prepared to contain 40 mg of furosemide diluted with normal saline to a total volume of 40 cc (1 mg / 1 cc) and control solution was prepared to contain only 40 cc of normal saline. Both solution was packaged in 50-cc syringe and prepared in similar fashion. The solution was administered after induction of anesthesia with rate of 2 cc per hour for 12 hours.
Baseline participant were collected before surgery. All cardiac surgery procedure was done in concordance to hospital standard operating procedure. The primary outcomes of the study were glomerular filtration rate, need of diuretic infusion dose after intervention, need of renal replacement therapy and the secondary outcomes were ICU length of stay and in hospital mortality. The calculated sample size estimated was 41 participants per group, accounting for drop-out rate, expected sample size was 45 participants per group (90 participants in total).
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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-
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Jakarta, Indonesia, 11420
- National Cardiovascular Center Harapan Kita Jakarta
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Furosemide group
Continuous furosemide 2 mg/hour for a period of 12 hours begins since anesthetic induction
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Furosemide 2 mg/hour infusion for 12 hours since induction
Other Names:
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Placebo Comparator: Placebo group
Continuous NaCl 0.9% 2 cc/hour for a period of 12 hours begins since anesthetic induction
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NaCl 0.9% 2 cc/hour for a period of 12 hours since anesthetic induction
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Glomerular Filtration Rate at Baseline
Time Frame: baseline / before induction to anesthesia
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Glomerular Filtration Rate measured at baseline
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baseline / before induction to anesthesia
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Glomerular Filtration Rate at 12 Hours From Drug Infusion
Time Frame: 12 hours from drug infusion
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Glomerular Filtration Rate measured at 12 hours from the initiation of drug infusion
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12 hours from drug infusion
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Glomerular Filtration Rate at 24 Hours From Drug Infusion
Time Frame: 24 hours after from infusion
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Glomerular Filtration Rate measured at 24 hours from the initiation of drug infusion
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24 hours after from infusion
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Glomerular Filtration Rate at 48 Hours From Drug Infusion
Time Frame: 48 hours from drug infusion
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Glomerular Filtration Rate measured at 48 hours from the initiation of drug infusion
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48 hours from drug infusion
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Glomerular Filtration Rate at 120 Hours From Drug Infusion
Time Frame: 120 hours from drug infusion
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Glomerular Filtration Rate measured at 120 hours from the initiation of drug infusion
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120 hours from drug infusion
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Therapeutic Dose of Continuous Diuretic Infusion
Time Frame: 28 days (or until hospital discharge)
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number of participants with Therapeutic Dose of Continuous Diuretic Infusion
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28 days (or until hospital discharge)
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Renal Replacement Therapy
Time Frame: 28 days (or until hospital discharge)
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number of participant with Renal Replacement Therapy
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28 days (or until hospital discharge)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ICU Length of Stay
Time Frame: 28 days (or until hospital discharge)
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The length of stay in ICU
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28 days (or until hospital discharge)
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In Hospital Mortality
Time Frame: 28 days (or until hospital discharge)
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number of In Hospital mortality
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28 days (or until hospital discharge)
|
Collaborators and Investigators
Investigators
- Study Director: Bambang Widyantoro, PhD, National Cardiovascular Center Harapan Kita
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Urologic Diseases
- Disease Attributes
- Renal Insufficiency
- Chronic Disease
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Heart Diseases
- Kidney Diseases
- Renal Insufficiency, Chronic
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Natriuretic Agents
- Membrane Transport Modulators
- Diuretics
- Sodium Potassium Chloride Symporter Inhibitors
- Furosemide
Other Study ID Numbers
- LB.02.01/VII/533/KEP024/2021
- NationalCCHK (Other Identifier: National Cardiac Center Harapan Kita)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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