NCT05939245

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Indonesia University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2023-07-24
• Primary completion: 2023-12-31
• Completion: 2024-06-30
• First posted: 2023-07-11
• Last updated: 2026-02-27

Locations

1 site across 1 country: Indonesia