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

Acute Kidney Injury Clinical Trial

— FURTHER  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03731117
• Other study ID #: P170404J
• Status: Terminated
• Phase: Phase 4
• Start date: July 15, 2019
• Est. completion date: December 7, 2020

Study information

• Verified date: December 2020
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: December 7, 2020
• Est. primary completion date: December 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 ?PP
• 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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Kidney Tubular Necrosis, Acute
• Necrosis

Intervention

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

Locations

Country	Name	City	State
France	CH Cote Basque	Bayonne
France	Hopital Bichat	Paris
France	Hopital Saint Louis	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	sensitivity	FST will be positive if patient is non responder : 2-hour urine output < 200mL	3 hour after FST
Secondary	6 hour urine output	measurement of urine out	6 hour after FST
Secondary	percentage of effective renal replacement therapy	Initiation of RRT	daily up to day 7
Secondary	death		daily up to day 7
Secondary	hemodynamic safety: noradrenaline dose	noradrenaline dose	6 hour after FST
Secondary	clinical safety: arterial pressure	modification of systolic, diastolic or mean arterial blood pressure	6 hour after FST