Acute Kidney Injury Due to SepsisNCT05939245
Comparison of Plasma Neutrophil Gelatinase-Associated Lipocalin (pNGAL) Level in De-resuscitation With Furosemide Group and Control Group
A study testing Furosemide Injection in people with Acute Kidney Injury Due to Sepsis, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
The impact of early de-resuscitation with furosemide on patients with sepsis-related acute kidney injury using pNGAL as the parameter of acute kidney injury. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury Due to Sepsis
- What is being tested?
- Furosemide Injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteIndonesia
- Study dates
- 24 Jul 2023to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sepsis patients with a cumulative balance of >1500 mL/day and urine output <0.8 cc/kg/hour.
Who cannot join
- Has undergone a kidney transplant procedure.
- End-stage chronic kidney failure.
- History of heart valve abnormalities.
- Congenital heart disease.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Rumah Sakit Cipto Mangunkusumo
Jakarta Pusat, DKI Jakarta, 10430
About this study
Official title: Comparison of Plasma Neutrophil Gelatinase-Associated Lipocalin (pNGAL) Level in De-Resuscitation With Furosemide Group and Control Group as a Predictor of Sepsis in Acute Kidney Injury Patients in the ICU Within 48 Hours of Treatment
The impact of early de-resuscitation with furosemide on patients with sepsis-related acute kidney injury using pNGAL as the parameter of acute kidney injury.
Read the detailed description
Sepsis-related acute kidney injury (SAKI) is a complication leading to morbidity and mortality in septic patients. Some 50% of AKI patients in the Intensive Care Unit (ICU) are sepsis patients, which is the highest cause of death in the ICU. In sepsis, there is systemic inflammation that causes endothelial damage, which manifests in capillary leakage. Fluid accumulation that has occurred since the patient came to the hospital due to a capillary leak in sepsis and is exacerbated by fluid resuscitation has a negative impact on the kidneys. Therefore, the aim of this study was to assess the effectiveness of early de-resuscitation using furosemide on the incidence of AKI in septic patients using pNGAL as a parameter of AKI.
This study used a double-blind, randomized clinical trial design. This study was conducted on septic patients with a cumulative balance of >1500 mL/day and urine output of 0.8 cc/kg/hour in the ICU of Dr. Cipto Mangunkusumo National Central Public Hospital in the July-December 2023 period. pNGAL levels were checked at the 0th and 48th hours of ICU care. A total of 48 subjects were divided into 2 groups: 24 patients in the treatment group were given a continuous injection of furosemide at 2 mg/hour, and 24 patients in the control group were given a placebo injection at 2 mg/hour. The patient's condition will be followed after the ICU stay for up to 28 days to record the need for renal replacement therapy and death.
- Conditions
- Acute Kidney Injury Due to Sepsis
- Being tested
- Furosemide Injection, Placebo Injection
- Keywords
- De-resuscitation, Furosemide, pNGAL, SAKI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Furosemide InjectionProcedure or surgery
Continuous infusion of furosemide is administered starting at 2 mg/hour and can be titrated until the target urine output of 1-2 cc/kg/hour is achieved for 48 hours. In case of hypotension (MAP <65 mmHg), norepinephrine is administered with titration starting at a dose of 0.05 mcg/kg/minute, along with a fluid loading of 4 cc/kg body weight or 300 cc within 5-10 minutes, until the target MAP of ≥65 mmHg is reached for 48 hours.
Placebo InjectionProcedure or surgery
Continuous infusion of placebo fluid is administered at a rate of 2 mL/hour. In case of hypotension (MAP <65 mmHg), norepinephrine is administered with titration starting at a dose of 0.05 mcg/kg/minute, along with a fluid loading of 4 cc/kg body weight or 300 cc within 5-10 minutes, until the target MAP of ≥65 mmHg is reached for 48 hours.
| Study group | Role | What they receive |
|---|---|---|
| Administration of continuous furosemide intravenous | Experimental | Not described Receives: Procedure: Furosemide Injection |
| Administration of continuous placebo intravenous | Placebo comparator | Not described Receives: Procedure: Placebo Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
pNGAL concentration
pNGAL measurement using ELISA at baseline (before intervention) and 48 hr after intervention
Measured: 2 days
Secondary outcomes (14)
Mechanical Ventilation Duration
Measuring hours usage of mechanical ventilation
Measured: from the first day mechanical ventilation usage until weaned to T-piece, assessed up to 28 days
Length of stay in ICU
length of stay in days during and after deresuscitation until the patient meets the ICU discharge criteria
Measured: 28 days
Renal Replacement Therapy
Necessity of renal replacement therapy within 28 days in ICU: needed/ not
Measured: 28 days
Fluid Balance (Daily)
Data extracted from medical record
Measured: 28 days
Lactate Concentration
Lactate measurement from blood sample at baseline level (before intervention) and 48 hours after deresuscitation
Measured: 2 days
Central Venous Pressure
Central venous pressure measurement using central vein catheter every 6 hours during deresuscitation
Measured: 2 days
28 days mortality
mortality within 28 days admission to ICU: deceased or survived
Measured: 28 days
Cumulative fluid balance (BIA)
Cumulative fluid balance measured using Bioelectrical Impedance Analysis. Measurements are conducted at baseline (before intervention) and 48 hr after intervention.
Measured: 2 days
Total Body Water (TBW)
Total Body Water measured using Bioelectrical Impedance Analysis. The total body water consists of Extracellular Water (ECW) and Intracellular Water (ICW). Measurements are conducted at baseline (before intervention) and 48 hr after intervention.
Measured: 2 days
Extracellular-to-intracellular water ratio
Extracellular-to-intracellular water ratio measured using Bioelectrical Impedance Analysis. Measurements are conducted at baseline (before intervention) and 48 hr after intervention.
Measured: 2 days
Intracellular Water (ICW)
ICW measured using Bioelectrical Impedance Analysis. Measurements are conducted at baseline (before intervention) and 48 hr after intervention.
Measured: 2 days
Extracellular Water (ECW)
Extracellular Water (ECW) using Bioelectrical Impedance Analysis. Measurements are conducted at baseline (before intervention) and 48 hr after intervention.
Measured: 2 days
Intravascular fluid
Intravascular fluid using Bioelectrical Impedance Analysis. Measurements are conducted at baseline (before intervention) and 48 hr after intervention.
Measured: 2 days
Phase angle
Phase angle using Bioelectrical Impedance Analysis. Measurements are conducted at baseline (before intervention) and 48 hr after intervention.
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start24 Jul 2023
- Primary completion31 Dec 2023
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney Injury Due to SepsisStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dita Aditianingsih, Universitas Indonesia
- Investigators
- Dita Aditianingsih, M.D, Ph.D, Principal investigator, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05939245
- Sponsor's protocol ID
- IndonesiaUAnes042
- Status last verified
- May 2025
- First submitted
- 25 Jun 2023
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Plasma Neutrophil Gelatinase-Associated Lipocalin (pNGAL) Level in De-Resuscitation With Furosemide Group and Control Group as a Predictor of Sepsis in Acute Kidney Injury Patients in the ICU Within 48 Hours of Treatment
- ClinicalTrials.gov ID
- NCT05939245
- Acronym / sponsor ID
- IndonesiaUAnes042
- Conditions
- Acute Kidney Injury Due to Sepsis
- Keywords
- De-resuscitation, Furosemide, pNGAL, SAKI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 24 Jul 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 11 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The impact of early de-resuscitation with furosemide on patients with sepsis-related acute kidney injury using pNGAL as the parameter of acute kidney injury.
Detailed description
Sepsis-related acute kidney injury (SAKI) is a complication leading to morbidity and mortality in septic patients. Some 50% of AKI patients in the Intensive Care Unit (ICU) are sepsis patients, which is the highest cause of death in the ICU. In sepsis, there is systemic inflammation that causes endothelial damage, which manifests in capillary leakage. Fluid accumulation that has occurred since the patient came to the hospital due to a capillary leak in sepsis and is exacerbated by fluid resuscitation has a negative impact on the kidneys. Therefore, the aim of this study was to assess the effectiveness of early de-resuscitation using furosemide on the incidence of AKI in septic patients using pNGAL as a parameter of AKI.
This study used a double-blind, randomized clinical trial design. This study was conducted on septic patients with a cumulative balance of >1500 mL/day and urine output of 0.8 cc/kg/hour in the ICU of Dr. Cipto Mangunkusumo National Central Public Hospital in the July-December 2023 period. pNGAL levels were checked at the 0th and 48th hours of ICU care. A total of 48 subjects were divided into 2 groups: 24 patients in the treatment group were given a continuous injection of furosemide at 2 mg/hour, and 24 patients in the control group were given a placebo injection at 2 mg/hour. The patient's condition will be followed after the ICU stay for up to 28 days to record the need for renal replacement therapy and death.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Administration of continuous furosemide intravenous | Experimental | Procedure: Furosemide Injection |
| Administration of continuous placebo intravenous | Placebo comparator | Procedure: Placebo Injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Sepsis patients with a cumulative balance of >1500 mL/day and urine output <0.8 cc/kg/hour.
Key exclusion criteria (4 listed)
- Has undergone a kidney transplant procedure.
- End-stage chronic kidney failure.
- History of heart valve abnormalities.
- Congenital heart disease.
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 InjectionContinuous infusion of furosemide is administered starting at 2 mg/hour and can be titrated until the target urine output of 1-2 cc/kg/hour is achieved for 48 hours. In case of hypotension (MAP <65 mmHg), norepinephrine is administered with titration starting at a dose of 0.05 mcg/kg/minute, along with a fluid loading of 4 cc/kg body weight or 300 cc within 5-10 minutes, until the target MAP of ≥65 mmHg is reached for 48 hours. | Procedure or surgery | Administration of continuous furosemide intravenous |
| Placebo InjectionContinuous infusion of placebo fluid is administered at a rate of 2 mL/hour. In case of hypotension (MAP <65 mmHg), norepinephrine is administered with titration starting at a dose of 0.05 mcg/kg/minute, along with a fluid loading of 4 cc/kg body weight or 300 cc within 5-10 minutes, until the target MAP of ≥65 mmHg is reached for 48 hours. | Procedure or surgery | Administration of continuous placebo intravenous |
Primary outcome
pNGAL concentration
Time frame: 2 days
pNGAL measurement using ELISA at baseline (before intervention) and 48 hr after intervention
14 secondary outcomes
Mechanical Ventilation Duration
Time frame: from the first day mechanical ventilation usage until weaned to T-piece, assessed up to 28 days
Length of stay in ICU
Time frame: 28 days
Renal Replacement Therapy
Time frame: 28 days
Fluid Balance (Daily)
Time frame: 28 days
Lactate Concentration
Time frame: 2 days
Central Venous Pressure
Time frame: 2 days
28 days mortality
Time frame: 28 days
Cumulative fluid balance (BIA)
Time frame: 2 days
Total Body Water (TBW)
Time frame: 2 days
Extracellular-to-intracellular water ratio
Time frame: 2 days
Intracellular Water (ICW)
Time frame: 2 days
Extracellular Water (ECW)
Time frame: 2 days
Intravascular fluid
Time frame: 2 days
Phase angle
Time frame: 2 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
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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.
Dita Aditianingsih, M.D, Ph.D principal investigator
Universitas Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Furosemide Injection in people with Acute Kidney Injury Due to Sepsis, run by Universitas Indonesia at 1 site in Indonesia.
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 1 inclusion and 4 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 27 Feb 2026. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
pNGAL concentration (time frame: 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Feb 2026.