Chronic Kidney DiseasePhase 2NCT04919564

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

A Phase 2 study testing Furosemide in 0.9 % NaCl 100 Mg/100 mL (1 mg/mL) and NaCl 0.9% in people with Chronic Kidney Disease and Cardiac Disease, run by National Cardiovascular Center Harapan Kita Hospital Indonesia at 1 site in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Chronic Kidney Disease, Cardiac Disease
What is being tested?: Furosemide in 0.9 % NaCl 100 Mg/100 mL (1 mg/mL) and NaCl 0.9%
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 90 participants
Where: 1 siteIndonesia
Study dates: 27 May 2021to 28 Feb 2022
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Indonesia1 site

National Cardiovascular Center Harapan Kita Jakarta
Jakarta, 11420

Other trials in Indonesia

About this study

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.

Read the 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).

Conditions: Chronic Kidney Disease, Cardiac Disease
Being tested: Furosemide in 0.9 % NaCl 100 Mg/100 mL (1 mg/mL), NaCl 0.9%
Keywords: Furosemide, Kidney Dysfunction, Glomerular Filtration Rate
Medical subject headings: Renal Insufficiency, Chronic, Heart Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Furosemide in 0.9 % NaCl 100 Mg/100 mL (1 mg/mL)Drug
Also called Lasix injection
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

Study groups in NCT04919564
Study group	Role	What they receive
Furosemide group	Experimental	Continuous furosemide 2 mg/hour for a period of 12 hours begins since anesthetic induction Receives: 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 Receives: Drug: NaCl 0.9%

What is being measured

The primary outcome is the main question the study is designed to answer.

Glomerular Filtration Rate at Baseline
Glomerular Filtration Rate measured at baseline
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 120 hours from drug infusion
Therapeutic Dose of Continuous Diuretic Infusion
number of participants with Therapeutic Dose of Continuous Diuretic Infusion
Measured: 28 days (or until hospital discharge)
Renal Replacement Therapy
number of participant with Renal Replacement Therapy
Measured: 28 days (or until hospital discharge)

Secondary outcomes (2)

ICU Length of Stay
The length of stay in ICU
Measured: 28 days (or until hospital discharge)
In Hospital Mortality
number of In Hospital mortality
Measured: 28 days (or until hospital discharge)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 May 202128 Feb 2022

First posted9 Jun 2021
Study start27 May 2021
Primary completion31 Dec 2021
Study completion28 Feb 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 90 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04919564
Sponsor's protocol ID: LB.02.01/VII/533/KEP024/2021
Other IDs: NationalCCHK
Status last verified: Mar 2023
First submitted: 27 May 2021
Last updated: 5 Jan 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Low Dose Continuous Furosemide Effect on Cardiac Surgery Patients With Kidney Dysfunction
ClinicalTrials.gov ID: NCT04919564
Acronym / sponsor ID: LB.02.01/VII/533/KEP024/2021
Conditions: Chronic Kidney Disease, Cardiac Disease
Keywords: Furosemide, Kidney Dysfunction, Glomerular Filtration Rate
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 90 participants (actual)
Lead sponsor: National Cardiovascular Center Harapan Kita Hospital IndonesiaUniversity, hospital or other
Study start: 27 May 2021 (actual)
Primary completion: 31 Dec 2021 (actual)
Study completion: 28 Feb 2022 (actual)
First posted: 9 Jun 2021 (actual)
Results: Posted 5 Jan 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Furosemide group	Experimental	Drug: Furosemide in 0.9 % NaCl 100 Mg/100 mL (1 mg/mL)Continuous furosemide 2 mg/hour for a period of 12 hours begins since anesthetic induction
Placebo group	Placebo comparator	Drug: NaCl 0.9%Continuous NaCl 0.9% 2 cc/hour for a period of 12 hours begins since anesthetic induction

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (8 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Furosemide in 0.9 % NaCl 100 Mg/100 mL (1 mg/mL)Also: Lasix injectionFurosemide 2 mg/hour infusion for 12 hours since induction	Drug	Furosemide group
NaCl 0.9%NaCl 0.9% 2 cc/hour for a period of 12 hours since anesthetic induction	Drug	Placebo group

Primary outcome

Glomerular Filtration Rate at Baseline
Time frame: baseline / before induction to anesthesia
Glomerular Filtration Rate measured at baseline
Glomerular Filtration Rate at 12 Hours From Drug Infusion
Time frame: 12 hours from drug infusion
Glomerular Filtration Rate measured at 12 hours from the initiation of drug infusion
Glomerular Filtration Rate at 24 Hours From Drug Infusion
Time frame: 24 hours after from infusion
Glomerular Filtration Rate measured at 24 hours from the initiation of drug infusion
Glomerular Filtration Rate at 48 Hours From Drug Infusion
Time frame: 48 hours from drug infusion
Glomerular Filtration Rate measured at 48 hours from the initiation of drug infusion
Glomerular Filtration Rate at 120 Hours From Drug Infusion
Time frame: 120 hours from drug infusion
Glomerular Filtration Rate measured at 120 hours from the initiation of drug infusion
Therapeutic Dose of Continuous Diuretic Infusion
Time frame: 28 days (or until hospital discharge)
number of participants with Therapeutic Dose of Continuous Diuretic Infusion
Renal Replacement Therapy
Time frame: 28 days (or until hospital discharge)
number of participant with Renal Replacement Therapy

2 secondary outcomes

ICU Length of Stay
Time frame: 28 days (or until hospital discharge)
In Hospital Mortality
Time frame: 28 days (or until hospital discharge)

Results and safety

Results posted to the registry on 5 Jan 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Furosemide	45	43
Control	45	44

Primary outcome: Glomerular Filtration Rate at Baseline

Time frame: baseline / before induction to anesthesia. Median (Full Range). Unit: mL/mnt/1.73 m^2

Measure	Furosemide n = 45	Control n = 45
Value	56 (30 to 88)	67 (35 to 89)

Primary outcome: Glomerular Filtration Rate at 12 Hours From Drug Infusion

Time frame: 12 hours from drug infusion. Median (Full Range). Unit: mL/mnt/1.73 m^2

Measure	Furosemide n = 43	Control n = 44
Value	45 (14 to 84)	46 (19 to 99)

Primary outcome: Glomerular Filtration Rate at 24 Hours From Drug Infusion

Time frame: 24 hours after from infusion. Median (Full Range). Unit: mL/mnt/1.73 m^2

Measure	Furosemide n = 43	Control n = 44
Value	39.5 (21 to 87)	38 (10 to 73)

Primary outcome: Glomerular Filtration Rate at 48 Hours From Drug Infusion

Time frame: 48 hours from drug infusion. Median (Full Range). Unit: mL/mnt/1.73 m^2

Measure	Furosemide n = 43	Control n = 44
Value	41 (15 to 89)	41.5 (9 to 84)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 30 days since administration of Furosemide or control. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Furosemide	0 of 43 (0%)	0 of 43 (0%)	1 of 43
Control	0 of 44 (0%)	0 of 44 (0%)	1 of 44

Limitations and caveats (from the sponsor): Technical problems with measurement leading to unreliable or uninterpretable data; others attendings decision leading to termination of subject

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bambang Widyantoro, PhD study director

National Cardiovascular Center Harapan Kita

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Glomerular Filtration Rate at Baseline (time frame: baseline / before induction to anesthesia). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04919564.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2024.