Acute Renal Failure on Dialysis (Disorder)
Conditions
Keywords
acute kidney injury, dialysis, fluid removal
Brief summary
The PROBE Fluid UK randomised controlled trial compares a protocol-based fluid removal strategy with usual care in critically ill patients with acute kidney injury receiving kidney replacement therapy.
Detailed description
Severe acute kidney injury (AKI) in the intensive care unit (ICU) is almost uniformly complicated by fluid accumulation, often leading to fluid overload. Congestion resulting from fluid accumulation is believed to contribute to organ failure. Removal of excess fluid is a central component of dialysis treatment, also known as kidney replacement therapy (KRT). However, there remain important knowledge gaps in our ability to remove excess fluid effectively and safely. If fluid is removed too slowly, fluid overload and its complications persist for longer. If fluid is removed too fast during KRT, patient's blood pressure may drop (ie hemodynamic instability may occur) which may precipitate complications. The optimal fluid management strategy is currently unknown. The PROBE Fluid UK study is a randomized clinical trial comparing a protocol-based fluid removal strategy with usual care in critically ill patients with AKI receiving KRT. The fluid management protocol is intended to achieve neutral or negative daily fluid balance by both preventing and treating fluid accumulation. The primary objective of this trial is to determine whether the intervention results in a difference in cumulative fluid balance from day of randomization to 5 days later. Secondary outcomes will include short-term patient outcomes, safety outcomes, and health resource utilization related to KRT delivery.
Interventions
PROCEDUREFluid removal
Fluid removal during kidney replacement therapy
Sponsors
Université de Montréal
Guy's and St Thomas' NHS Foundation Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adult patients aged ≥18 years 2. Admitted to the intensive care unit 3. Acute kidney injury defined by the KDIGO criteria 4. Planned initiation of KRT within 12 hours or the receipt of KRT for AKI for ≤48 hours
Exclusion criteria
1. Lack of commitment to maintain kidney, pharmacologic or respiratory support at the time of screening, or probable transition to comfort care within 48 hours according to the treating clinician 2. Probable discharge from the ICU within 48 hours according to treating clinician 3. Severe burn injury (\>10% of body surface area) 4. Severe abnormality in serum sodium (\>155 or \<120 mmol/L) 5. Important ongoing fluid losses are present and/or are expected to require continued maintenance IV fluids during the next 48 hours 6. The clinical care team believes that the proposed intervention is inappropriate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| fluid balance | day 5 after randomization | cumulative fluid balance |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| mortality | 90 days after randomization | all-cause mortality |
| ICU stay | 90 days after randomization | Number of ICU free days |
| enrolment | 20 months | Proportion of eligible patients who were enrol in the trial |
| mechanical ventilation | 28 days after randomization | Number of mechanical ventilation-free days |
| KRT duration | 5 days | hours of KRT support |
| vasoactive therapy | 28 days after randomization | Number of vasoactive therapy-free days |
Contacts
Primary ContactMarlies Ostermann (work), PhD
Backup ContactGillian Radcliffe
Outcome results
None listed