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

NCT05939245 | Completed

• 1 other identifier: IndonesiaUAnes042
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Kidney Injury Due to Sepsis

Keywords

De-resuscitation; Furosemide; pNGAL; SAKI

Outcome Measures

Primary Outcomes (1)

• pNGAL concentration

  pNGAL measurement using ELISA at baseline (before intervention) and 48 hr after intervention

  2 days

Secondary Outcomes (14)

• Mechanical Ventilation Duration

  from the first day mechanical ventilation usage until weaned to T-piece, assessed up to 28 days

• Length of stay in ICU

  28 days

• Renal Replacement Therapy

  28 days

• Fluid Balance (Daily)

  28 days

• Lactate Concentration

  2 days

Study Arms (2)

Administration of continuous furosemide intravenous

EXPERIMENTAL

Procedure: Furosemide Injection

Administration of continuous placebo intravenous

PLACEBO COMPARATOR

Procedure: Placebo Injection

Interventions

Furosemide Injection PROCEDURE

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.

Administration of continuous furosemide intravenous

Placebo Injection PROCEDURE

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.

Administration of continuous placebo intravenous

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Rumah Sakit Cipto Mangunkusumo

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

MeSH Terms

Interventions

Furosemide

Intervention Hierarchy (Ancestors)

Sulfanilamides; Sulfonamides; Amides; Organic Chemicals; Aniline Compounds; Amines; Sulfones; Sulfur Compounds

Study Officials

• Dita Aditianingsih, M.D, Ph.D

  Indonesia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, Anesthesiologist Consultant

Study Record Dates

• First Submitted: June 25, 2023
• First Posted: July 11, 2023
• Study Start: July 24, 2023
• Primary Completion: December 31, 2023
• Study Completion: June 30, 2024
• Last Updated: February 27, 2026

Record last verified: 2025-05

Locations

ID (1)