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REVERSE-AKI Randomized Controlled Pilot Trial (REVERSE-AKI)

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ClinicalTrials.gov Identifier: NCT03251131
Recruitment Status : Recruiting
First Posted : August 16, 2017
Last Update Posted : November 21, 2018
Sponsor:
Collaborators:
Austin Hospital, Melbourne Australia
Guy's and St Thomas Hospital
University Hospital, Ghent
Medical University Innsbruck
Lausanne University Hospital
Information provided by (Responsible Party):
Suvi Vaara, Helsinki University Central Hospital

Brief Summary:

Observational studies among patients with acute kidney injury (AKI) have shown an association with fluid accumulation and increased mortality. Trials among other subgroups of critically ill patients have demonstrated that restricting fluid input after the initial resuscitation appears safe.

The objective if this study is to determine whether a fluid restrictive treatment regimen will lead to a lower cumulative fluid balance at 72 hours from randomization in critically ill patients with AKI and whether this approach is safe and feasible.


Condition or disease Intervention/treatment Phase
Acute Kidney Injury Critical Illness Other: Restrictive fluid management Phase 2

Detailed Description:

Acute kidney injury (AKI) is common in the critically ill and associates with adverse outcomes. Patients with AKI are frequently have low urine output and are at high risk of developing fluid overload. Fluid overload has been associated with an increased risk for mortality in such patients. Previous trials in critically ill patients found that a 'restrictive fluid therapy' after resuscitation was safe. Implementing a restrictive fluid therapy approach in patients with AKI may also be of benefit. To date, however, no randomized trial has been performed to evaluate the safety and feasibility of implementing a 'restrictive fluid therapy' approach compared to standard fluid therapy in patients with AKI.

In this pilot randomized controlled trial we will evaluate the implementation of a fluid restrictive approach, compared to standard therapy, in adult critically ill patients with acute kidney injury.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: REstricted Fluid Therapy VERsus Standard trEatment in Acute Kidney Injury - REVERSE-AKI Randomized Controlled Pilot Trial
Actual Study Start Date : November 8, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : March 2020

Arm Intervention/treatment
Experimental: Restrictive fluid management
Restrictive fluid management Targeting a negative or maximum 300ml positive daily fluid balance.
Other: Restrictive fluid management
Daily fluid input is restricted to drugs and nutrition. Fluid boluses and blood products can be given if clinically indicated. Matching fluid output to fluid input whenever possible using diuretics if needed, and additionally, if clinically necessary and plausible, commencing renal replacement therapy. If renal replacement therapy is not deemed clinically desirable, acceptance of a less than targeted fluid balance.

No Intervention: Standard therapy
Randomized allocation of standard care at the clinician's discretion in accordance with current best practice.



Primary Outcome Measures :
  1. Cumulative fluid balance [ Time Frame: 72 hours ]

Secondary Outcome Measures :
  1. Duration of acute kidney injury [ Time Frame: ICU discharge/14 days ]
    Defined according to Kidney Diseases: Improving Global Outcomes criteria

  2. Number of patients requiring renal replacement therapy [ Time Frame: 14 days ]
  3. Cumulative fluid balance [ Time Frame: 24 hours ]
  4. Cumulative fluid balance [ Time Frame: ICU discharge/ 7 days ]
  5. Cumulative dose of diuretics [ Time Frame: ICU discharge/ 7 days ]
  6. Mechanical ventilation free days alive [ Time Frame: 14 days ]
  7. Vasopressor free days and alive [ Time Frame: 14 days ]
  8. Renal replacement therapy free days and alive [ Time Frame: 90 days ]
  9. Dialysis dependence [ Time Frame: 90 days ]
  10. All-cause mortality [ Time Frame: 90 days ]

Other Outcome Measures:
  1. Number of serious adverse events and reactions [ Time Frame: 7 days ]
    1. Ventricular tachycardia/fibrillation
    2. New onset of atrial fibrillation requiring medication/defibrillation
    3. Ischemic events

    i. Acute myocardial infarction ii. Cerebral ischemia verified by CT or MRI scan.

    iii. Intestinal ischemia verified by endoscopy or open surgery.

    iv. Acute peripheral limb ischemia d. Radiologically diagnosed pulmonary edema e. Adverse events related to renal replacement therapy and diuretics use f. Frequency of hypokalaemia (serum K <3.5mmol/L) g. Frequency of hypomagnesaemia (serum Mg <0.8mmol/L)




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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:

  1. 18-years or older and admitted to critical care with an arterial line in place
  2. The patient has been in critical care for at least 12 hours but no more than 72 hours
  3. The patient has AKI but is not receiving acute RRT:

    For the purpose of the study AKI is defined the by the following criteria:

    1. Increase in serum creatinine over 1.5-times above baseline without a decline of 27umol/l or more from the last preceding measurement (at least 12 hours apart) AND/OR
    2. Overall urine output less than 0.5ml/kg/h (or 6ml/kg) for the previous 12h (with urine catheter in place for the period)
  4. The patient is judged by the treating clinician not to be intravascularly hypovolemic
  5. The patient is likely to remain in critical care for 48 hours after randomization

Exclusion Criteria:

  1. Active bleeding necessitating transfusion
  2. Maintenance fluid therapy is necessary due to diabetic ketoacidosis, non-ketotic coma, severe burns or other clinical reason determined by the medical staff
  3. Need for RRT due to intoxication of a dialyzable toxin
  4. Commencement of RRT is expected in the next 6 hours
  5. On chronic renal replacement therapy (maintenance dialysis or renal transplant)
  6. Presence or a strong clinical suspicion of parenchymal AKI (for example glomerulonephritis, vasculitis, acute interstitial nephritis), or post-renal obstruction
  7. Severe hyponatremia (Na <125mmol/L) or hypernatremia (Na >155mmol/L)
  8. Need for extracorporeal membrane oxygenation or molecular absorbent recirculating system (MARS-therapy)
  9. Pregnant or lactating
  10. Patients who are not to receive full active treatment
  11. No baseline creatinine available
  12. Lack of consent
  13. The patient has been enrolled in another trial where co-enrollment is not feasible

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): NCT03251131


Contacts
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Contact: Suvi Vaara, MD, PhD +35894711 suvi.vaara@hus.fi

Locations
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Australia, Victoria
Austin Hospital Completed
Melbourne, Victoria, Australia, 3048
Austria
Innsbruck University Hospital Not yet recruiting
Innsbruck, Austria
Contact: Michael Joannidis       michael.joannidis@i-med.ac.at   
Principal Investigator: Michael Joannidis         
Belgium
Ghent University Hospital Recruiting
Ghent, Belgium
Contact: Eric Hoste       eric.hoste@ugent.be   
Principal Investigator: Eric Hoste         
Finland
Helsinki University Hospital Recruiting
Helsinki, Finland
Contact: Suvi Vaara       suvi.vaara@hus.fi   
Principal Investigator: Ville Pettilä         
Germany
Westfälische Wilhelms-Universität Münster Not yet recruiting
Münster, Germany
Contact: Alexander Zarbock, MD, PhD         
Switzerland
Lausanne University Hospital Recruiting
Lausanne, Switzerland
Contact: Antoine Schneider       antoine.schneider@chuv.ch   
Principal Investigator: Antoine Schneider         
United Kingdom
Guy's and St Thomas Hospital Not yet recruiting
London, United Kingdom
Contact: Marlies Ostermann       marlies.ostermann@gstt.nhs.uk   
Principal Investigator: Marlies Ostermann         
Sponsors and Collaborators
Helsinki University Central Hospital
Austin Hospital, Melbourne Australia
Guy's and St Thomas Hospital
University Hospital, Ghent
Medical University Innsbruck
Lausanne University Hospital
Investigators
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Principal Investigator: Suvi Vaara, MD, PhD Division of Intensive Care Medicine, Department of Anesthesiology, Intensive Care and Pain Medicine, University of Helsinki and Helsinki University Hospital, Helsinki, Finland
Principal Investigator: Marlies Ostermann, MD, PhD Department of Critical Care and Nephrology, King's College London, Guy's and St Thomas Hospital, Foundation Hospital, London

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Responsible Party: Suvi Vaara, MD, PhD, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT03251131     History of Changes
Other Study ID Numbers: HUS/1782/2017
First Posted: August 16, 2017    Key Record Dates
Last Update Posted: November 21, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Acute Kidney Injury
Critical Illness
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Disease Attributes
Pathologic Processes