None listed
Conditions
Brief summary
Net ultrafiltration (NUF) (i.e., fluid removal) during continuous renal replacement therapy (CRRT) enables management of volume status and is supported by international clinical guidelines. Emerging evidence from epidemiologic studies of critically ill patients with acute kidney injury suggests that higher intensities of NUF (i.e., higher NUF rates) impair renal recovery and are associated with increased mortality. However, no randomised studies have compared patient outcomes achieved by targeting a moderate NUF rate to usual care. The primary aim of this study is to determine whether targeting a moderate NUF rate in critically ill patients receiving CRRT affects renal recovery and patient survival compared to usual care. The primary outcome is the time to renal recovery, defined as the number of hours between the initiation and discontinuation of renal replacement therapy (CRRT or intermittent RRT). Death will be considered as a semi-competing risk. Secondary outcomes relate to the feasibility, efficacy, and safety of the intervention.
Interventions
Continuous renal replacement therapy (CRRT) involves removal of solutes and fluid via an extracorporeal circuit. Intensity of solute removal is described by the 'exchange volume'. Intensity of fluid removal is described by the 'net ultrafiltration (NUF) rate'.
The study treatment for this trial is a targeted NUF rate of between 1.01 and 1.75 mL/kg/h. NUF rate will be calculated using actual body weight, capped at extremes of 50 and 120 kg. This will be administered by the bedside ICU nurse who
Continuous renal replacement therapy (CRRT) involves removal of solutes and fluid via an extracorporeal circuit. Intensity of solute removal is described by the 'exchange volume'. Intensity of fluid removal is described by the 'net ultrafiltration (NUF) rate'. The study treatment for this trial is a targeted NUF rate of between 1.01 and 1.75 mL/kg/h. NUF rate will be calculated using actual body weight, capped at extremes of 50 and 120 kg. This will be administered by the bedside ICU nurse who controls the CRRT settings. The duration of the intervention will be for the length of time that the patient remains on CRRT. As a crossover study, centres will be allocated to intervention or control arms for a period of 6 months each, with a 2 month washout period occurring in between the two periods. Other elements of the CRRT prescription including the modality of CRRT and choice of anticoagulation will be at the discretion of the clinician. Compliance will be monitored by audit of patient medical records
Sponsors
Australia and New Zealand Intensive Care Society Research Centre
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Clinician-based decision that the patient has a requirement for CRRT 2. Acute kidney injury (AKI), as defined by stage 2 or greater KDIGO criteria
Exclusion criteria
1. Age <18 years 2. Pregnancy 3. Death is deemed to be imminent or inevitable during this admission, and either the attending physician, patient or substitute decision-maker is not committed to active treatment 4. Prior exposure to CRRT or intermittent renal replacement therapy (IRRT) this admission or previous enrolment in this study 5. Chronic haemodialysis or peritoneal dialysis 6. Concurrent extracorporeal membrane oxygenation
Outcome results
None listed