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

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Terminated

CT.gov ID

NCT03731117

Collaborator

(none)

Enrollment

Locations

Arm

16.8

Actual Duration (Months)

3.7

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Kidney Injury	Drug: Furosemide	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

11 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Prospective, non-comparative, multicenter, studyProspective, non-comparative, multicenter, study

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 15, 2019

Actual Primary Completion Date :

Dec 7, 2020

Actual Study Completion Date :

Dec 7, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: FST FUROSEMIDE STRESS TEST	Drug: Furosemide 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 Other Names: furosemide stress test

Arm

Intervention/Treatment

Experimental: FST

FUROSEMIDE STRESS TEST

Drug: Furosemide

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

Other Names:

furosemide stress test

Outcome Measures

Primary Outcome Measures

Need for renal replacement therapy or death [Before day 7]
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 [3 hour after FST]
FST will be positive if patient is non responder : 2-hour urine output < 200mL

Secondary Outcome Measures

6 hour urine output [6 hour after FST]
measurement of urine out
percentage of effective renal replacement therapy [daily up to day 7]
Initiation of RRT
death [daily up to day 7]
hemodynamic safety: noradrenaline dose [6 hour after FST]
noradrenaline dose
clinical safety: arterial pressure [6 hour after FST]
modification of systolic, diastolic or mean arterial blood pressure

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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