- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02458157
Forced Fluid Removal in High Risk Acute Kidney Injury (FFAKI)
Forced Fluid Removal vs. Usual Intensive Care in High-risk Acute Kidney Injury With Severe Fluid Overload - A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Acute kidney injury (AKI) is a common and serious complication in patients admitted to ICU. A core element of critical care is resuscitation with crystalloid solutions. In many cases fluid accumulates and patients become fluid overloaded (positive fluid balance > 10% of bodyweight). This is especially true in patients with AKI, since they often have impaired ability to excrete salt and water. Most observational suggests harm with increased positive fluid balance.
Objectives: To assess feasibility of forced fluid removal with diuretics and/or CRRT in ICU patients with AKI and severe fluid overload, compared to current clinical practice.
Design: Multicentre, parallel group, randomized, assessor blinded pilot-trial with adequate generation of allocation sequence, and allocation concealment.
Trial Size: The pilot study is planned to include 50 patients. Inclusion is expected to start in August 2015.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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-
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Aalborg, Denmark, 9000
- Aalborg Universitetshospital, Anæstesi og intensiv afdeling
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Hillerød, Denmark, 3400
- Nordsjællands Hospital. Dept. of Anaesthesiology and Intensive Care.
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København Ø, Denmark, 2100
- Rigshospitale. ITA 4131 / Dept. of intensive care
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age ≥ 18 years of age
- Acute Kidney Injury defined according to the KDIGO criteria
- Renal Recovery Score ≤ 60%. (Calculated using www.renal-recovery-score.com)
- Fluid overload defined as a positive fluid balance ≥ 10% of ideal body weight.
- Able to undergo randomization within 12 hours of fulfilling other inclusion criteria
Exclusion Criteria:
- Known pre-hospitalization advanced chronic kidney disease. (eGFR < 30 mL/minute/1.73 m2 or chronic RRT.)
- Severe hypoxic respiratory failure (use of invasive ventilation and FiO2 > 80% and PEEP > 10 cm H2O)
- Severe burn injury (≥ 10% TBSA)
- Severe hypo- or hyper- natremia (< 120 or > 155 mmol/l)
- Hepatic coma
- Mentally disabled undergoing forced treatment
- Pregnancy/breast feeding
- Lack of commitment for on-going life support including RRT
- Lack of informed consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Forced Fluid Removal
The experimental intervention is guided by a therapeutic goal of average negative fluid balance ≥ 1 ml/kg/h and safety variables indicating inadequate circulation (lactate ≥ 4, MAP < 50 or mottling beyond the edge of kneecaps). The effect of fluid removal is evaluated three times daily (06:00. 14:00 and 22:00), while the safety variables are evaluated continuously. Resuscitation is started if one or more signs of inadequate circulation is present. The first choice for fluid removal is diuretic therapy with furosemide, which is continued for a minimum of 8 hours. If the therapeutic goal (negative fluid balance ≥ 1 ml/kg/h) is not achieved and/or maintained by furosemide alone, then fluid removal with continuous renal replacement therapy (CRRT) is initiated. |
Other Names:
Other Names:
The physiologic response to fluid removal is monitored with three variables indicating inadequate circulation. These are:
Mottling and MAP are monitored continuously and lactate is measured routinely 4-6 times each day and on clinical indication. If one or more variable is present:
|
Active Comparator: Usual Care
Usual Care at the discretion of the treating clinicians, except for the initiation of renal replacement therapy (RRT).
|
All interventions are performed at the discretion of the treating physician apart from initiation of renal replacement therapy which is discouraged unless one or more of the following criteria are met:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cumulative fluid balance
Time Frame: 5 days
|
Calculated as the sum of daily intake - daily output, as registered on the daily ICU observation charts.
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5 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cumulative fluid balance
Time Frame: ICU stay expected average of 10 days
|
participants will be followed for the duration of ICU stay, an expected average of 10 days
|
ICU stay expected average of 10 days
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Mean daily fluid balance
Time Frame: ICU stay expected average of 10 days
|
participants will be followed for the duration of ICU stay, an expected average of 10 days
|
ICU stay expected average of 10 days
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Major protocol violations
Time Frame: ICU stay expected average of 10 days
|
participants will be followed for the duration of ICU stay, an expected average of 10 days
|
ICU stay expected average of 10 days
|
Time to neutral cumulative fluid balance
Time Frame: 90 days
|
No. of days until neutral cumulative fluid balance is achieved.
Participants will be followed until neutral fluid balance is achieved or they reach the end of the observation period (90 days)
|
90 days
|
Accumulated serious adverse reactions
Time Frame: 90 days
|
Serious adverse reactions related to fluid removal(atrial fibrillation, ischemic events and organ failure), furosemide (severe electrolyte disturbance, severe thrombocytopenia, hearing loss agranulocytosis and allergic reactions) and the infusion of noradrenaline (cerebral hemorrhage, cardiac arrhythmia, psychiatric symptoms) will be examined
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90 days
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
All cause mortality
Time Frame: 90 days
|
90 days
|
|
Days alive and out of hospital
Time Frame: 90 days
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90 days
|
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Days alive and out of mechanical ventilation
Time Frame: 90 days
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90 days
|
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Days alive and out of renal replacement therapy
Time Frame: 90 days
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90 days
|
|
Renal recovery
Time Frame: 90 days
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Defined as 5 consecutive days of:
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90 days
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Morten H Bestle, MD, Ph D, Nordsjællands Hospital. Dept. of Anaesthesiology and Intensive Care.
- Study Chair: Anders Perner, Md, Ph D, Rigshospitalet. ITA 4131 / Dept of Intensive Care
- Study Chair: Jens-Ulrik Jensen, MD, Ph D, Rigshospitalet, University of Copenhagen CHIP, Department of Infectious Diseases and Rheumatology, Section 2100
- Study Chair: Michael Ibsen, MD, Ph D, Nordsjællands Hospital. Dept. of Anaesthesiology and Intensive Care.
- Study Chair: Rasmus E Berthelsen, MD, Nordsjællands Hospital. Dept. of Anaesthesiology and Intensive Care.
Publications and helpful links
General Publications
- Berthelsen RE, Perner A, Jensen AK, Rasmussen BS, Jensen JU, Wiis J, Behzadi MT, Bestle MH. Forced fluid removal in intensive care patients with acute kidney injury: The randomised FFAKI feasibility trial. Acta Anaesthesiol Scand. 2018 Aug;62(7):936-944. doi: 10.1111/aas.13124. Epub 2018 Apr 17.
- Berthelsen RE, Itenov T, Perner A, Jensen JU, Ibsen M, Jensen AEK, Bestle M. Forced fluid removal versus usual care in intensive care patients with high-risk acute kidney injury and severe fluid overload (FFAKI): study protocol for a randomised controlled pilot trial. Trials. 2017 Apr 24;18(1):189. doi: 10.1186/s13063-017-1935-2.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Kidney Diseases
- Urologic Diseases
- Disease Attributes
- Renal Insufficiency
- Wounds and Injuries
- Critical Illness
- Acute Kidney Injury
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Natriuretic Agents
- Membrane Transport Modulators
- Diuretics
- Sodium Potassium Chloride Symporter Inhibitors
- Furosemide
Other Study ID Numbers
- FFAKI
- 2015-001701-13 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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