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Artificial Kidney Initiation in Kidney Injury (AKIKI)

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ClinicalTrials.gov Identifier: NCT01932190
Recruitment Status : Completed
First Posted : August 30, 2013
Last Update Posted : June 24, 2016
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:

The best timing for renal replacement therapy (RRT) in intensive care unit (ICU) patients with acute kidney injury (AKI) is unknown. The investigators will conduct a multicenter prospective randomized open-label trial to compare two strategies in ICU patients (mechanically ventilated and/or receiving catecholamine infusion) with severe AKI defined as RIFLE F classification. These patients will be randomly allocated to one of the following strategies:

  1. an "early" strategy where RRT is started immediately when a RIFLE F status is documented
  2. a "delayed" strategy where RRT (in patients who also present RIFLE F renal failure) is started only in case of occurrence of one or more of the following events ("Alert Criteria"): oliguria or anuria lasting for more than 72 hours after randomization, serum urea concentration > 40 mmol /L, serum potassium concentration > 6 mmol /L, serum potassium concentration > 5.5 mmol /L that persists despite well-conducted medical treatment with at least sodium bicarbonate and / or glucose-insulin infusion, arterial pH < 7.15 in the context of pure metabolic acidosis (PaCO2 <35 mmHg) or in the context of mixed acidosis with PaCO2> 50 mmHg without possibility of lowering this PaCO2 value, acute overload pulmonary edema generating severe hypoxemia requiring oxygen flow> 5L/min in spontaneously breathing patients or FiO2> 50% in mechanically (invasive or noninvasive) ventilated to maintain SpO2> 95%, despite diuretic therapy.

The primary endpoint is overall survival, measured from the date of randomization to the date of death, regardless of the cause. The minimum duration of each patient's follow-up will be 60 days.


Condition or disease Intervention/treatment Phase
Renal Replacement Therapy for Acute Kidney Injury in Intensive Care Unit Procedure: Early RRT strategy Procedure: Delayed RRT strategy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 620 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Artificial Kidney Initiation in Kidney Injury, a Multicenter Randomised Trial
Study Start Date : September 2013
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Arm Intervention/treatment
Experimental: Early RRT strategy
the "early" strategy : RRT is started immediately when a RIFLE F status is documented
Procedure: Early RRT strategy
the "early" strategy : RRT is started immediately when a RIFLE F status is documented

Experimental: Delayed RRT strategy
The "delayed" strategy : RRT (in patients who also present RIFLE F renal failure) is started only in case of occurrence of one or more of the "Alert Criteria"
Procedure: Delayed RRT strategy
The "delayed" strategy : RRT (in patients who also present RIFLE F renal failure) is started only in case of occurrence of one or more of the "Alert Criteria": see summary




Primary Outcome Measures :
  1. Overall survival [ Time Frame: 60 days ]
    The primary endpoint is overall survival, measured from the date of randomization to the date of death, regardless of the cause. The minimum duration of each patient's follow-up will be 60 days.


Secondary Outcome Measures :
  1. Survival rate [ Time Frame: 28 days ]
    Survival rate at day 28

  2. percentage of patients requiring at least a RRT in the "waiting" strategy [ Time Frame: 28 days ]
  3. time to withdrawal RRT [ Time Frame: 28 days ]
  4. rate of adverse events potentially related to the AKI or RRT [ Time Frame: 28 days ]
  5. rate of nosocomial infections [ Time Frame: 28 days ]
  6. rate of ventilator free days [ Time Frame: 28 days ]
  7. rate of RRT free days [ Time Frame: 28 days ]
  8. rate of vasopressors free days [ Time Frame: 28 days ]
  9. length of stay in ICU and hospital [ Time Frame: 60 days ]
  10. rate of limitations of treatment [ Time Frame: 28 days ]
  11. total cost of consumables related to RRT [ Time Frame: 28 days ]
    total cost of consumables related to RRT between day 1 and day 28



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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 The following five criteria are required for inclusion

  1. Hospitalized in intensive care unit
  2. Age ≥ 18 years
  3. Acute kidney injury compatible with the diagnosis of acute tubular necrosis defined by a clinical ischemic or toxic insult context
  4. Have an AKI classified as RIFLE F, that is to say, with at least one of the following three criteria:

    • creatinine> 354 mmol / l or > 3 times the baseline creatinine
    • anuria for more than 12 hours
    • oliguria defined as urine output < 0.3 ml / kg / h or < 500ml/d for more than 24 hours
  5. Mechanical ventilation and/or catecholamines infusion (noradrenaline or/and adrenaline)

Non-inclusion criteria

One or more of the following criteria:

  • Chronic renal failure (defined as creatinine clearance < 30 ml / min)
  • Patients already enrolled in the study
  • Inclusion criteria number 4 present for more than 5 hours
  • Acute renal failure due to:

    • urinary tract obstruction
    • renal vessels obstruction
    • tumor lysis syndrome
    • thrombotic microangiopathy
    • acute glomerulonephritis
  • Intoxication with a dialyzable product
  • Child-Pugh class C liver cirrhosis
  • Renal transplant
  • Cardiac arrest without awakening at time of potential inclusion
  • Moribund state
  • Decision to limit treatment
  • RRT already started for the current episode of AKI
  • Presenting (at the time of potential inclusion) a strong indication for immediate RRT

    • oligoanuria for more than 3 days
    • serum urea concentration > 40 mmol / l serum potassium concentration > 6 mmol /L, serum potassium concentration > 5.5 mmol /L that persists despite well-conducted medical treatment with at least sodium bicarbonate and / or glucose-insulin infusion, arterial pH < 7.15 in the context of pure metabolic acidosis (PaCO2 <35 mmHg) or in the context of mixed acidosis with PaCO2> 50 mmHg without possibility of lowering this PaCO2 value, acute overload pulmonary edema generating severe hypoxemia requiring oxygen flow> 5L/min in spontaneously breathing patients or FiO2> 50% in mechanically (invasive or noninvasive) ventilated to maintain SpO2> 95%, despite diuretic therapy.
  • Under cardiopulmonary bypass
  • Included in another clinical trial on RRT modalities.

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): NCT01932190


Locations
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France
Hôpital Louis Mourier
Colombes, France, 92700
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Didier DREYFUSS, MD Assistance Publique - Hôpitaux de Paris
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01932190    
Other Study ID Numbers: AOM12456 - K120102
2013-A00765-40 ( Other Identifier: IDRCB )
First Posted: August 30, 2013    Key Record Dates
Last Update Posted: June 24, 2016
Last Verified: August 2013
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Acute Kidney Injury
Critical Care
Renal Replacement Therapy
Treatment Outcome
Additional relevant MeSH terms:
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Acute Kidney Injury
Wounds and Injuries
Renal Insufficiency
Kidney Diseases
Urologic Diseases