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临床试验/NCT05939245
NCT05939245已完成不适用

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

Indonesia University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年7月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
pNGAL concentration

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

pNGAL concentration

时间窗: 2 days

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

次要结局

  • Mechanical Ventilation Duration(from the first day mechanical ventilation usage until weaned to T-piece, assessed up to 28 days)
  • 28 days mortality(28 days)
  • Intracellular Water (ICW)(2 days)
  • Total Body Water (TBW)(2 days)
  • Renal Replacement Therapy(28 days)
  • Length of stay in ICU(28 days)
  • Fluid Balance (Daily)(28 days)
  • Lactate Concentration(2 days)
  • Central Venous Pressure(2 days)
  • Extracellular Water (ECW)(2 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dita Aditianingsih

Principal investigator, Anesthesiologist Consultant

Indonesia University

研究点 (2)

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