Clinical trial NCT02458157: Forced Fluid Removal in High Risk Acute Kidney Injury
Official title: Forced Fluid Removal vs. Usual Intensive Care in High-risk Acute Kidney Injury With Severe Fluid Overload - A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Acute Kidney Injury
Fluid Overload
Critical Illness
Keywords: ICU
Intensive
CRRT
Fluid Removal
AKI
Critical Care
Lead sponsor: Nordsjaellands Hospital
Sponsor class: OTHER
Collaborators: name: Rigshospitalet, Denmark
name: Aalborg University Hospital
First posted: 2015-06-01
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this pilot trial is to assess the feasibility of forced fluid removal in patients admitted to the intensive care unit (ICU) with high-risk AKI and severe fluid overload. The intervention will use furosemide infusion and/or continuous renal replacement therapy (CRRT) to achieve and maintain a neutral cumulative fluid balance. The intervention will be compared to standard of care as reflected in the kidney disease improving global outcome (KDIGO) guidelines.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cumulative fluid balance
timeFrame: 5 days
Secondary outcomes:
measure: Cumulative fluid balance
timeFrame: ICU stay expected average of 10 days
measure: Mean daily fluid balance
timeFrame: ICU stay expected average of 10 days
measure: Major protocol violations
timeFrame: ICU stay expected average of 10 days
measure: Time to neutral cumulative fluid balance
timeFrame: 90 days
measure: Accumulated serious adverse reactions
timeFrame: 90 days
Other outcomes:
measure: All cause mortality
timeFrame: 90 days
measure: Days alive and out of hospital
timeFrame: 90 days
measure: Days alive and out of mechanical ventilation
timeFrame: 90 days
measure: Days alive and out of renal replacement therapy
timeFrame: 90 days
measure: Renal recovery
timeFrame: 90 days
Locations:
city: Aalborg
country: Denmark
facility: Aalborg Universitetshospital, Anæstesi og intensiv afdeling
city: Hillerød
country: Denmark
facility: Nordsjællands Hospital. Dept. of Anaesthesiology and Intensive Care.
city: København Ø
country: Denmark
facility: Rigshospitale. ITA 4131 / Dept. of intensive care
Study officials:
affiliation: Nordsjællands Hospital. Dept. of Anaesthesiology and Intensive Care.
name: Morten H Bestle, MD, Ph D
role: PRINCIPAL_INVESTIGATOR
affiliation: Rigshospitalet. ITA 4131 / Dept of Intensive Care
name: Anders Perner, Md, Ph D
role: STUDY_CHAIR
affiliation: Rigshospitalet, University of Copenhagen CHIP, Department of Infectious Diseases and Rheumatology, Section 2100
name: Jens-Ulrik Jensen, MD, Ph D
role: STUDY_CHAIR
affiliation: Nordsjællands Hospital. Dept. of Anaesthesiology and Intensive Care.
name: Michael Ibsen, MD, Ph D
role: STUDY_CHAIR
affiliation: Nordsjællands Hospital. Dept. of Anaesthesiology and Intensive Care.
name: Rasmus E Berthelsen, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.