Early treatment of fluid accumulation in patients admitted to the intensive care unit with acute kidney injury

Phase 1

• Conditions: Fluid overload associated with acute kidney injury in patients admitted to the intensive care unit; MedDRA version: 18.0Level: PTClassification code 10069339Term: Acute kidney injurySystem Organ Class: 10038359 - Renal and urinary disorders; MedDRA version: 18.0Level: PTClassification code 10016803Term: Fluid overloadSystem Organ Class: 10027433 - Metabolism and nutrition disorders; MedDRA version: 18.0Level: PTClassification code 10022519Term: Intensive careSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2015-001701-13-DK
• Lead Sponsor: ordsjællands Hospital. Dept. of Anaesthesiology and Intensive Care.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07-01
• Last Update Posted: 17 July 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

•Age = 18 years of age
•Acute Kidney Injury defined according to the KDIGO criteria
•Renal Recovery Score = 50%. (Calculated using www.renal-recovery-score.com)
•Fluid overload defined as a positive fluid balance = 10% of admission body weight.
•Able to undergo randomization within 12 hours of fulfilling other inclusion criteria

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

•Known allergy to furosemide or sulphonamides
•Known pre-hospitalization advanced chronic kidney disease (GFR < 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 dysnatremia (< 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 & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The objective of this pilot trial is to assess the feasibility of forced fluid removal in high-risk AKI patients with severe fluid overload. The intervention will use furosemide infusion and/or CRRT to achieve and maintain a neutral cumulative fluid balance. The intervention will be compared to standard of care as reflected in the KDIGO guidelines.;Secondary Objective: Not applicable;Primary end point(s): Cumulative fluid balance 5 days after randomisation.<br>oCalculated as the sum of daily intake – daily output, as registered on the daily ICU observation charts.<br>;Timepoint(s) of evaluation of this end point: 5 days after randomization

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): •Mean daily fluid balance during ICU stay<br>•Cumulative fluid balance during the entire ICU stay.<br>•Number of patients with one or more major protocol violations.<br>•Time to neutral cumulative fluid balance<br>•Accumulated SAR’s in each intervention arm during the ICU stay.<br>;Timepoint(s) of evaluation of this end point: 90 days after randomization