None listed
Conditions
Brief summary
The RESPECT trial aims to determine the clinical impact of a conservative fluid protocol (CFP), that is minimizing fluid administered and maximizing urine produced, compared to usual care in patients admitted to the intensive care unit and have an acute impairment in their kidney function. The hypothesis is that a CFP will result is less severe derangement in kidney function and will result in better patient outcomes, such as less need for dialysis. This will be done by randomizing patients to one of the two groups: CFP and usual care. The expected outcomes are divided into feasibility and clinical outcomes. The main feasibility outcome will be a difference in fluid administered after three days between the two groups. This is to ensure that CFP differs sufficiently from usual care. The main clinical outcomes is a reduction in blood levels of creatinine, which is a marker of the severity of kidney injury.
Interventions
The trial intervention will be a conservative fluid protocol (CFP), which will empower treating clinician to achieve daily negative fluid balances after randomisation. The CFP will consist of bundle of therapies targeting fluid input and fluid output to guide the treating team to achieve targets.
The trial intervention will be applied for seven days, or until discharge from the ICU. The intervention will only be applied when the patient is admitted to the ICU, it will not be applied in a ward b
The trial intervention will be a conservative fluid protocol (CFP), which will empower treating clinician to achieve daily negative fluid balances after randomisation. The CFP will consist of bundle of therapies targeting fluid input and fluid output to guide the treating team to achieve targets. The trial intervention will be applied for seven days, or until discharge from the ICU. The intervention will only be applied when the patient is admitted to the ICU, it will not be applied in a ward based setting. 1. Twice-daily formal assessment of fluid balance 2. At the time of assessment, is a negative fluid balance being achieved since the last assessment? a. If yes, continue current management b. If no, progressively implement the following interventions: i. Cease maintenance IV fluids (i.e. <10ml/hr) ii. Early commencement of diuretic therapy iii. Use concentrated enteral nutrition iv. Use concentrated antibiotics and medications where feasible Adherence will be monitored by local research staff who will monitor the fluid balance of patients randomised to RFP. If the targets are not being met they will discuss with the clinical staff.
Sponsors
Metro South Hospital and Health Service
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Adult patient, age >=18 currently admitted to ICU • Acute kidney injury defined by any of the following: o >= 1.5 times baseline creatinine (assume normal if baseline unknown) OR o >= 27 umol/L (0.3mg/dL) absolute increase in creatinine OR o < 0.5ml/kg/hr urine output for at least 6 hours • Deemed to be adequately fluid resuscitated as per treating clinician’s assessment • Patient to remain in ICU until the day after tomorrow - AKI FB Risk Score greater than or equal to 32
Exclusion criteria
• Maintenance fluid deemed necessary (e.g. for diabetic ketoacidosis or severe burns) • Requirement for RRT, such as dialysable toxin • Commencement of RRT for AKI is likely in the next 6 hours • Chronic haemodialysis or peritoneal dialysis • Acute renal transplant • Presence or strong suspicion of post-renal obstruction • Severe hyponatremia (Na <125mmol/L) or hypernatremia (Na >155mmol/L) • Need for extracorporeal membrane oxygenation • Previous enrolment in this study • Pregnant or lactating • Patients who are not to receive full active treatment
Outcome results
None listed