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

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ClinicalTrials.gov Identifier: NCT03731117
Recruitment Status : Not yet recruiting
First Posted : November 6, 2018
Last Update Posted : May 29, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date  ICMJE October 10, 2018
First Posted Date  ICMJE November 6, 2018
Last Update Posted Date May 29, 2019
Estimated Study Start Date  ICMJE June 15, 2019
Estimated Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 2, 2018)
  • Need for renal replacement therapy or death [ Time Frame: 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 [ Time Frame: 3 hour after FST ]
    FST will be positive if patient is non responder : 2-hour urine output < 200mL
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03731117 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 2, 2018)
  • 6 hour urine output [ Time Frame: 6 hour after FST ]
    measurement of urine out
  • percentage of effective renal replacement therapy [ Time Frame: daily up to day 7 ]
    Initiation of RRT
  • death [ Time Frame: daily up to day 7 ]
  • hemodynamic safety: noradrenaline dose [ Time Frame: 6 hour after FST ]
    noradrenaline dose
  • clinical safety: arterial pressure [ Time Frame: 6 hour after FST ]
    modification of systolic, diastolic or mean arterial blood pressure
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE FURosemide Stress Test to Predict Need of Renal Replacement THERapy in Ischemic Acute Tubular Necrosis in ICU
Official Title  ICMJE FURosemide Stress Test to Predict Need of Renal Replacement THERapy in Ischemic Acute Tubular Necrosis in ICU
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
Prospective, non-comparative, multicenter, study
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute Kidney Injury
Intervention  ICMJE 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 Name: furosemide stress test
Study Arms  ICMJE Experimental: FST
FUROSEMIDE STRESS TEST
Intervention: Drug: Furosemide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: November 2, 2018)
70
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 15, 2020
Estimated Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: BOUADMA Lila, MD 01 40 25 77 03 ext 33 lila.bouadma@aphp.fr
Contact: VINCLAIR Camille, MD cvinclair@ch-cotebasque.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03731117
Other Study ID Numbers  ICMJE P170404J
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP