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FURosemide Stress Test to Predict Need of Renal Replacement THERapy in Ischemic Acute Tubular Necrosis in ICU (FURTHER)

Primary Purpose

Acute Kidney Injury

Status
Terminated
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Furosemide
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Kidney Injury focused on measuring Ischemic Acute Kidney Injury, Intensive care units, AKI, ICU, FST, FUROSEMIDE STRESS TEST, RRT, Renal Replacement Therapy, sepsis, Cardio-pulmonary bypass

Eligibility Criteria

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

Inclusion Criteria:

  • Age over 18 years old
  • Hospitalized in ICU at day of inclusion
  • Diagnosis of sepsis defined as proven or suspected infection and increase of the SOFA (Sequential Organ Failure Assessment) score by 2 points or more compared to basal OR Cardiothoracic surgery with CBP (Cardiopulmonary bypass) within 72 hours before inclusion
  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • CH Cote Basque
  • Hopital Saint Louis
  • Hopital Bichat

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FST

Arm Description

FUROSEMIDE STRESS TEST

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

6 hour urine output
measurement of urine out
percentage of effective renal replacement therapy
Initiation of RRT
death
hemodynamic safety: noradrenaline dose
noradrenaline dose
clinical safety: arterial pressure
modification of systolic, diastolic or mean arterial blood pressure

Full Information

First Posted
October 10, 2018
Last Updated
December 11, 2020
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT03731117
Brief Title
FURosemide Stress Test to Predict Need of Renal Replacement THERapy in Ischemic Acute Tubular Necrosis in ICU
Acronym
FURTHER
Official Title
FURosemide Stress Test to Predict Need of Renal Replacement THERapy in Ischemic Acute Tubular Necrosis in ICU
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Terminated
Why Stopped
Study end date exceeded and insufficient number of subjects needed for analysis. 11 patients included / 70 theoretical patients
Study Start Date
July 15, 2019 (Actual)
Primary Completion Date
December 7, 2020 (Actual)
Study Completion Date
December 7, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

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
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.
Detailed Description
FURTHER will enroll consecutive patients with AKI KDIGO stage 1 or 2 associated with a sepsis or following a cardiac surgery with CPB within 72h. Patients must have achieved a hemodynamic stabilization confirmed by clinical (no need for intravenous fluids, no significant variation of noradrenaline) and non-clinical (trans-thoracic echocardiography, passive leg rise or other validated tool) assessment. Included patients will receive 1 to 1.5 mg/kg of FUROSEMIDE. Urine output will be measured for 6 hours and compensated by the same volume of intravenous crystalloids. Need for RRT will be assess at 2-hour, 6-hour and daily up to day 7, following the AKIKI-study delayed initiation arm criteria. FURTHER aim to evaluate FST in a well-defined prospective cohort of ischemic ATN-related AKI as predictor of need for RRT within a week.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury
Keywords
Ischemic Acute Kidney Injury, Intensive care units, AKI, ICU, FST, FUROSEMIDE STRESS TEST, RRT, Renal Replacement Therapy, sepsis, Cardio-pulmonary bypass

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
Prospective, non-comparative, multicenter, study
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FST
Arm Type
Experimental
Arm Description
FUROSEMIDE STRESS TEST
Intervention Type
Drug
Intervention Name(s)
Furosemide
Other Intervention Name(s)
furosemide stress test
Intervention Description
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
Primary Outcome Measure Information:
Title
Need for renal replacement therapy or death
Description
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.
Time Frame
Before day 7
Title
sensitivity
Description
FST will be positive if patient is non responder : 2-hour urine output < 200mL
Time Frame
3 hour after FST
Secondary Outcome Measure Information:
Title
6 hour urine output
Description
measurement of urine out
Time Frame
6 hour after FST
Title
percentage of effective renal replacement therapy
Description
Initiation of RRT
Time Frame
daily up to day 7
Title
death
Time Frame
daily up to day 7
Title
hemodynamic safety: noradrenaline dose
Description
noradrenaline dose
Time Frame
6 hour after FST
Title
clinical safety: arterial pressure
Description
modification of systolic, diastolic or mean arterial blood pressure
Time Frame
6 hour after FST

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age over 18 years old Hospitalized in ICU at day of inclusion Diagnosis of sepsis defined as proven or suspected infection and increase of the SOFA (Sequential Organ Failure Assessment) score by 2 points or more compared to basal OR Cardiothoracic surgery with CBP (Cardiopulmonary bypass) within 72 hours before inclusion 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 Exclusion Criteria: 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
Facility Information:
Facility Name
CH Cote Basque
City
Bayonne
Country
France
Facility Name
Hopital Saint Louis
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Hopital Bichat
City
Paris
ZIP/Postal Code
75018
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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FURosemide Stress Test to Predict Need of Renal Replacement THERapy in Ischemic Acute Tubular Necrosis in ICU

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