Comparison of Plasma Neutrophil Gelatinase-Associated Lipocalin (pNGAL) Level in De-resuscitation With Furosemide Group and Control Group

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.

Study Overview

• Status: Completed
• Conditions: Acute Kidney Injury Due to Sepsis
• Intervention / Treatment: Procedure: Furosemide Injection; Procedure: Placebo Injection

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • DKI Jakarta
    • Jakarta Pusat, DKI Jakarta, Indonesia, 10430
      • Rumah Sakit Cipto Mangunkusumo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Sepsis patients with a cumulative balance of >1500 mL/day and urine output <0.8 cc/kg/hour.

Exclusion Criteria:

• Has undergone a kidney transplant procedure.
• End-stage chronic kidney failure.
• History of heart valve abnormalities.
• Congenital heart disease.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Administration of continuous furosemide intravenous	Procedure: Furosemide Injection; 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 Comparator: Administration of continuous placebo intravenous	Procedure: Placebo Injection; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pNGAL concentration	pNGAL measurement using ELISA at baseline (before intervention) and 48 hr after intervention	2 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mechanical Ventilation Duration	Measuring hours usage of mechanical ventilation	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	28 days
Renal Replacement Therapy	Necessity of renal replacement therapy within 28 days in ICU: needed/ not	28 days
Fluid Balance (Daily)	Data extracted from medical record	28 days
Lactate Concentration	Lactate measurement from blood sample at baseline level (before intervention) and 48 hours after deresuscitation	2 days
Central Venous Pressure	Central venous pressure measurement using central vein catheter every 6 hours during deresuscitation	2 days
28 days mortality	mortality within 28 days admission to ICU: deceased or survived	28 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.	2 days
Extracellular Water (ECW)	Extracellular Water (ECW) using Bioelectrical Impedance Analysis. Measurements are conducted at baseline (before intervention) and 48 hr after intervention.	2 days
Intracellular Water (ICW)	ICW measured using Bioelectrical Impedance Analysis. Measurements are conducted at baseline (before intervention) and 48 hr after intervention.	2 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.	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.	2 days
Intravascular fluid	Intravascular fluid using Bioelectrical Impedance Analysis. Measurements are conducted at baseline (before intervention) and 48 hr after intervention.	2 days
Phase angle	Phase angle using Bioelectrical Impedance Analysis. Measurements are conducted at baseline (before intervention) and 48 hr after intervention.	2 days

Collaborators and Investigators

• Sponsor: Indonesia University
• Investigators: Principal Investigator: Dita Aditianingsih, M.D, Ph.D, Indonesia University

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2023
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): June 30, 2024

Study Registration Dates

• First Submitted: June 25, 2023
• First Submitted That Met QC Criteria: July 2, 2023
• First Posted (Actual): July 11, 2023

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 24, 2026
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Furosemide; De-resuscitation; pNGAL; SAKI
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Renal Insufficiency; Acute Kidney Injury; Sepsis; Sulfur Compounds; Organic Chemicals; Amides; Aniline Compounds; Amines; Sulfonamides; Sulfanilamides; Sulfones; Furosemide
• Other Study ID Numbers: IndonesiaUAnes042

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No