Forced Fluid Removal in High Risk Acute Kidney Injury (FFAKI)

Nordsjaellands Hospital

Status and phase: Terminated; Phase 4

Conditions: Acute Kidney Injury; Critical Illness; Fluid Overload

Treatments: Drug: Furosemide (Furix); Other: Usual Care; Other: Continuous renal replacement therapy (CRRT); Other: Resuscitation

Study type: Interventional

Funder types: Other

Identifiers

NCT02458157

FFAKI

2015-001701-13 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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21 participants in 2 patient groups

Forced Fluid Removal

Experimental group

Description:

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.

Treatment:

Other: Resuscitation

Other: Continuous renal replacement therapy (CRRT)

Drug: Furosemide (Furix)

Usual Care

Active Comparator group

Description:

Usual Care at the discretion of the treating clinicians, except for the initiation of renal replacement therapy (RRT).

Treatment:

Other: Usual Care