Forced Fluid Removal in High Risk Acute Kidney Injury

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.

Conditions

• Acute Kidney Injury
• Fluid Overload
• Critical Illness

Interventions

DRUG

Furosemide (Furix)

* Loading dose: 40 mg I.V. * Infusion rate 40 mg/h * Continued until neutral cumulative fluid balance is achieved (the overall treatment goal) or average negative fluid balance is below 1 ml/kg/h for 8 hours.

OTHER

Continuous renal replacement therapy (CRRT)

* Initiated in case of contraindications or inadequate effect of furosemide. * Fluid removal is started at 2 ml/kg/h * The efficacy is evaluated 3 times daily and removal rate increased by 0.5 ml/kg/h if the therapeutic goal is not achieved

OTHER

Resuscitation

The physiologic response to fluid removal is monitored with three variables indicating inadequate circulation. These are: * Mottling beyond the edge of kneecaps * Hypotension (MAP \< 50) resistant to inotropes and vasopressors * Plasma lactate ≥ 4 mmol/l 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: 1. Fluid removal is paused 2. A crystalloid fluid bolus of 250-500 ml is given 3. Circulatory status is reevaluated within 30 minutes 4. Step 1-3 is repeated until signs of inadequate circulation have been resolved for minimum 1 hour 5. Fluid removal is restarted in 25% reduced dose for minimum 4 hours before evaluation of effect.

OTHER

Usual Care

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: * Hyperkalaemia (p-K+ \> 6 mmol/l) * Severe metabolic acidosis attributable to AKI (pH \< 7.25 and standard base excess \< -10 mmol/l) resistant to IV bicarbonate infusion * Severe respiratory failure with PaO2/FiO2 \< 13 kPa and bilateral infiltrates/oedema on the chest x-ray. * Progressive azotaemia and a blood urea nitrogen (BUN) \> 25 mmol/l.

Sponsors & Collaborators

• Rigshospitalet, Denmark

  collaborator OTHER

• Aalborg University Hospital

  collaborator OTHER

• Nordsjaellands Hospital

  lead OTHER

Principal Investigators

• Morten H Bestle, MD, Ph D · Nordsjællands Hospital. Dept. of Anaesthesiology and Intensive Care.

• Anders Perner, Md, Ph D · Rigshospitalet. ITA 4131 / Dept of Intensive Care

• Jens-Ulrik Jensen, MD, Ph D · Rigshospitalet, University of Copenhagen CHIP, Department of Infectious Diseases and Rheumatology, Section 2100

• Michael Ibsen, MD, Ph D · Nordsjællands Hospital. Dept. of Anaesthesiology and Intensive Care.

• Rasmus E Berthelsen, MD · Nordsjællands Hospital. Dept. of Anaesthesiology and Intensive Care.

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-10-31

Primary Completion

2017-06-08

Completion

2017-06-08

Countries

• Denmark

Study Locations