NCT03731117

Brief Summary

Ischemic acute tubular necrosis (ATN) is one of the main cause of acute kidney injury (AKI) in intensive care units (ICU). Sepsis and cardio-pulmonary bypass (CPB) are major providers. There is no validated tool to predict the evolution of AKI is ICU. Furosemide Stress Test (FST) may predict evolution of ATN-related AKI outside ICU in terms of progressive AKI, need for renal replacement therapy (RRT) or inpatient mortality with improved performance comparing to biomarkers. FST has not been validated in a prospective cohort in ICU in the settings of ischemic ATN. FURTHER aim to determine whether FST would be a useful tool to identify patients with slight to moderate AKI (KDIGO stage 1 and 2) who will evolve towards need for RRT following AKIKI (The Artificial Kidney Initiation in Kidney Injury ) delayed initiation criteria.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jul 2019

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 10, 2018

Completed
27 days until next milestone

First Posted

Study publicly available on registry

November 6, 2018

Completed
8 months until next milestone

Study Start

First participant enrolled

July 15, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 7, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 7, 2020

Completed
Last Updated

December 16, 2020

Status Verified

December 1, 2020

Enrollment Period

1.4 years

First QC Date

October 10, 2018

Last Update Submit

December 11, 2020

Conditions

Acute Kidney Injury

Keywords

Ischemic Acute Kidney InjuryIntensive care unitsAKIICUFSTFUROSEMIDE STRESS TESTRRTRenal Replacement TherapysepsisCardio-pulmonary bypass

Outcome Measures

Primary Outcomes (2)

  • Need for renal replacement therapy or death

    Need for renal replacement therapy will be define according to the AKIKI study (Gaudry S, Hajage D, Schortgen F, Martin-Lefevre L, Pons B, Boulet E, et al. Initiation Strategies for Renal-Replacement Therapy in the Intensive Care Unit. N Engl J Med. 2016 Jul 14;375(2):122-33). Need for RRT following AKIKI delayed initiation criteria. FST performance will be compared to the need of RRT or death.

    Before day 7

  • sensitivity

    FST will be positive if patient is non responder : 2-hour urine output \< 200mL

    3 hour after FST

Secondary Outcomes (5)

  • 6 hour urine output

    6 hour after FST

  • percentage of effective renal replacement therapy

    daily up to day 7

  • death

    daily up to day 7

  • hemodynamic safety: noradrenaline dose

    6 hour after FST

  • clinical safety: arterial pressure

    6 hour after FST

Study Arms (1)

FST

EXPERIMENTAL

FUROSEMIDE STRESS TEST

Drug: Furosemide

Interventions

FurosemideDRUG

Furosemide (FUROSEMIDE®) 20 mg / 2ml, ampoule for injection 1 mg / kg slow intravenous injection 1.5 mg / kg if chronic exposure to diuretics in the week prior to inclusion Measurement of urine output after two and six hours. Compensation of diuresis by same volume of crystalloids over a 6-hour period

Also known as: furosemide stress test
FST

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age over 18 years old
  • Adequate cardiac output and volemia assessed by cardiac ultrasound, venous saturation in Oxygen (ScVO2) or ΔPP
  • Hemodynamic stabilization : stable norepinephrine dosage (or \<20% variations) with no vascular filling during the last 3 hours
  • AKI stage I or II in KDIGO classification

You may not qualify if:

  • Chronic Kidney Disease with glomerular filtration rate ≤ 30 ml/mn/1,73m2
  • Obstructive AKI
  • AKI stage III in KDIGO classification
  • Known allergy to loop diuretics
  • Contraindications to Furosemide
  • FST not feasible within 12 hours of eligibility
  • Previous AKI during the same hospitalization
  • Pregnancy or breastfeeding women
  • Subject under a legal protective measure
  • No affiliation to a social regime or CMU

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

CH Cote Basque

Bayonne, France

Location

Hopital Saint Louis

Paris, 75010, France

Location

Hopital Bichat

Paris, 75018, France

Location

MeSH Terms

Conditions

Acute Kidney InjurySepsis

Interventions

Furosemide

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SulfanilamidesSulfonamidesAmidesOrganic ChemicalsAniline CompoundsAminesSulfonesSulfur Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Prospective, non-comparative, multicenter, study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2018

First Posted

November 6, 2018

Study Start

July 15, 2019

Primary Completion

December 7, 2020

Study Completion

December 7, 2020

Last Updated

December 16, 2020

Record last verified: 2020-12

Locations

FR(3)