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Completed

NCT Number: NCT05939245

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rumah Sakit Cipto Mangunkusumo

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. pNGAL concentration

    Time frame: 2 days

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

Secondary outcomes

  1. Mechanical Ventilation Duration

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

    Measuring hours usage of mechanical ventilation

  2. Length of stay in ICU

    Time frame: 28 days

    length of stay in days during and after deresuscitation until the patient meets the ICU discharge criteria

  3. Renal Replacement Therapy

    Time frame: 28 days

    Necessity of renal replacement therapy within 28 days in ICU: needed/ not

  4. Fluid Balance (Daily)

    Time frame: 28 days

    Data extracted from medical record

  5. Lactate Concentration

    Time frame: 2 days

    Lactate measurement from blood sample at baseline level (before intervention) and 48 hours after deresuscitation

  6. Central Venous Pressure

    Time frame: 2 days

    Central venous pressure measurement using central vein catheter every 6 hours during deresuscitation

  7. 28 days mortality

    Time frame: 28 days

    mortality within 28 days admission to ICU: deceased or survived

  8. Cumulative fluid balance (BIA)

    Time frame: 2 days

    Cumulative fluid balance measured using Bioelectrical Impedance Analysis. Measurements are conducted at baseline (before intervention) and 48 hr after intervention.

  9. Total Body Water (TBW)

    Time frame: 2 days

    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.

  10. Extracellular-to-intracellular water ratio

    Time frame: 2 days

    Extracellular-to-intracellular water ratio measured using Bioelectrical Impedance Analysis. Measurements are conducted at baseline (before intervention) and 48 hr after intervention.

  11. Intracellular Water (ICW)

    Time frame: 2 days

    ICW measured using Bioelectrical Impedance Analysis. Measurements are conducted at baseline (before intervention) and 48 hr after intervention.

  12. Extracellular Water (ECW)

    Time frame: 2 days

    Extracellular Water (ECW) using Bioelectrical Impedance Analysis. Measurements are conducted at baseline (before intervention) and 48 hr after intervention.

  13. Intravascular fluid

    Time frame: 2 days

    Intravascular fluid using Bioelectrical Impedance Analysis. Measurements are conducted at baseline (before intervention) and 48 hr after intervention.

  14. Phase angle

    Time frame: 2 days

    Phase angle using Bioelectrical Impedance Analysis. Measurements are conducted at baseline (before intervention) and 48 hr after intervention.

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Jul 11, 2023
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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