Clinical trial NCT05939245: Comparison of Plasma Neutrophil Gelatinase-Associated Lipocalin (pNGAL) Level in De-resuscitation With Furosemide Group and Control Group
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Kidney Injury Due to Sepsis
Keywords: De-resuscitation
Furosemide
pNGAL
SAKI
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2023-07-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: pNGAL concentration
timeFrame: 2 days
Secondary outcomes:
measure: Mechanical Ventilation Duration
timeFrame: from the first day mechanical ventilation usage until weaned to T-piece, assessed up to 28 days
measure: Length of stay in ICU
timeFrame: 28 days
measure: Renal Replacement Therapy
timeFrame: 28 days
measure: Fluid Balance (Daily)
timeFrame: 28 days
measure: Lactate Concentration
timeFrame: 2 days
measure: Central Venous Pressure
timeFrame: 2 days
measure: 28 days mortality
timeFrame: 28 days
measure: Total Body Water (TBW)
timeFrame: 2 days
measure: Extracellular Water (ECW)
timeFrame: 2 days
measure: Intracellular Water (ICW)
timeFrame: 2 days
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Rumah Sakit Cipto Mangunkusumo
state: DKI Jakarta
Study officials:
affiliation: Indonesia University
name: Dita Aditianingsih, M.D, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: