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

Primary Purpose

Acute Kidney Injury Due to Sepsis

Status
Recruiting
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
Furosemide Injection
Placebo Injection
Sponsored by
Indonesia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Kidney Injury Due to Sepsis focused on measuring De-resuscitation, Furosemide, pNGAL, SAKI

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Rumah Sakit Cipto MangunkusumoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Administration of continuous furosemide intravenous

Administration of continuous placebo intravenous

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Mechanical Ventilation Duration
Measuring hours usage of mechanical ventilation
Length of stay in ICU
length of stay in days during and after deresuscitation until the patient meets the ICU discharge criteria
Renal Replacement Therapy
Necessity of renal replacement therapy within 28 days in ICU: needed/ not
Fluid Balance (Daily)
Data extracted from medical record
Lactate Concentration
Lactate measurement from blood sample at baseline level (before intervention) and 48 hours after deresuscitation
Central Venous Pressure
Central venous pressure measurement using central vein catheter every 6 hours during deresuscitation
28 days mortality
mortality within 28 days admission to ICU: deceased or survived
Total Body Water (TBW)
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.
Extracellular Water (ECW)
Extracellular Water (ECW) using Bioelectrical Impedance Analysis. Measurements are conducted at baseline (before intervention) and 48 hr after intervention.
Intracellular Water (ICW)
ICW measured using Bioelectrical Impedance Analysis. Measurements are conducted at baseline (before intervention) and 48 hr after intervention.

Full Information

First Posted
June 25, 2023
Last Updated
July 26, 2023
Sponsor
Indonesia University
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1. Study Identification

Unique Protocol Identification Number
NCT05939245
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 24, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indonesia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury Due to Sepsis
Keywords
De-resuscitation, Furosemide, pNGAL, SAKI

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Administration of continuous furosemide intravenous
Arm Type
Experimental
Arm Title
Administration of continuous placebo intravenous
Arm Type
Placebo Comparator
Intervention Type
Procedure
Intervention Name(s)
Furosemide Injection
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Placebo Injection
Intervention Description
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 Outcome Measure Information:
Title
pNGAL concentration
Description
pNGAL measurement using ELISA at baseline (before intervention) and 48 hr after intervention
Time Frame
2 days
Secondary Outcome Measure Information:
Title
Mechanical Ventilation Duration
Description
Measuring hours usage of mechanical ventilation
Time Frame
from the first day mechanical ventilation usage until weaned to T-piece, assessed up to 28 days
Title
Length of stay in ICU
Description
length of stay in days during and after deresuscitation until the patient meets the ICU discharge criteria
Time Frame
28 days
Title
Renal Replacement Therapy
Description
Necessity of renal replacement therapy within 28 days in ICU: needed/ not
Time Frame
28 days
Title
Fluid Balance (Daily)
Description
Data extracted from medical record
Time Frame
28 days
Title
Lactate Concentration
Description
Lactate measurement from blood sample at baseline level (before intervention) and 48 hours after deresuscitation
Time Frame
2 days
Title
Central Venous Pressure
Description
Central venous pressure measurement using central vein catheter every 6 hours during deresuscitation
Time Frame
2 days
Title
28 days mortality
Description
mortality within 28 days admission to ICU: deceased or survived
Time Frame
28 days
Title
Total Body Water (TBW)
Description
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.
Time Frame
2 days
Title
Extracellular Water (ECW)
Description
Extracellular Water (ECW) using Bioelectrical Impedance Analysis. Measurements are conducted at baseline (before intervention) and 48 hr after intervention.
Time Frame
2 days
Title
Intracellular Water (ICW)
Description
ICW measured using Bioelectrical Impedance Analysis. Measurements are conducted at baseline (before intervention) and 48 hr after intervention.
Time Frame
2 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dita Aditianingsih, M.D, Ph.D
Phone
+618151819244
Email
ditaaditiaa@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dita Aditianingsih, M.D, Ph.D
Organizational Affiliation
Indonesia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rumah Sakit Cipto Mangunkusumo
City
Jakarta Pusat
State/Province
DKI Jakarta
ZIP/Postal Code
10430
Country
Indonesia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dita Aditianingsih, M.D., Ph.D

12. IPD Sharing Statement

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

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