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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 : Recruiting
First Posted : November 6, 2018
Last Update Posted : September 18, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective, 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 : July 15, 2019
Estimated Primary Completion Date : July 30, 2020
Estimated Study Completion Date : November 15, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Furosemide

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 Name: furosemide stress test




Primary Outcome Measures :
  1. 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.


  2. sensitivity [ Time Frame: 3 hour after FST ]
    FST will be positive if patient is non responder : 2-hour urine output < 200mL


Secondary Outcome Measures :
  1. 6 hour urine output [ Time Frame: 6 hour after FST ]
    measurement of urine out

  2. percentage of effective renal replacement therapy [ Time Frame: daily up to day 7 ]
    Initiation of RRT

  3. death [ Time Frame: daily up to day 7 ]
  4. hemodynamic safety: noradrenaline dose [ Time Frame: 6 hour after FST ]
    noradrenaline dose

  5. clinical safety: arterial pressure [ Time Frame: 6 hour after FST ]
    modification of systolic, diastolic or mean arterial blood pressure



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03731117


Contacts
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Contact: BOUADMA Lila, MD 01 40 25 77 03 ext 33 lila.bouadma@aphp.fr
Contact: VINCLAIR Camille, MD cvinclair@ch-cotebasque.fr

Locations
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France
CH Cote Basque Recruiting
Bayonne, France
Contact: Camille VINCLAIR, MD         
Hopital Saint Louis Not yet recruiting
Paris, France, 75010
Contact: Matthieu LEGRAND, MD    0631439665    matthieu.legrand@aphp.fr   
Hopital Bichat Recruiting
Paris, France, 75018
Contact: Lila BOUADMA, MD       lila.bouadma@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03731117     History of Changes
Other Study ID Numbers: P170404J
First Posted: November 6, 2018    Key Record Dates
Last Update Posted: September 18, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Ischemic Acute Kidney Injury
Intensive care units
AKI
ICU
FST
FUROSEMIDE STRESS TEST
RRT
Renal Replacement Therapy
sepsis
Cardio-pulmonary bypass
Additional relevant MeSH terms:
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Furosemide
Acute Kidney Injury
Kidney Tubular Necrosis, Acute
Necrosis
Pathologic Processes
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action