NCT02458157

Forced Fluid Removal in High Risk Acute Kidney Injury

Forced Fluid Removal vs. Usual Intensive Care in High-risk Acute Kidney Injury With Severe Fluid Overload - A Randomized Controlled Trial

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Nordsjaellands Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Kidney Injury
• Fluid Overload
• Critical Illness

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-10-01
• Primary completion: 2017-06-08
• Completion: 2017-06-08
• First posted: 2015-06-01
• Last updated: 2017-07-06

Locations

3 sites across 1 country: Denmark