None listed
Conditions
Brief summary
The conservative fluid feasibility study is a phase II, prospective parallel-group (1:1) randomised controlled study (N=100). The aim is to determine if a conservative fluid management strategy, compared to usual care, can achieve a clinically significant reduction in intravenous fluid intake in critically ill adults admitted to ICU for more than 48 hours. Most general adult intensive care unit (ICU) patients who are expected to remain in ICU for more than 2 days will be eligible. Patients in the intervention (conservative) group will receive intravenous fluid therapy according to a succinct fluid practice guideline comprising bolus fluid, maintenance fluid, replacement of lost fluid, and fluid administered with drugs or other infusions. Patients in the control group will receive fluid in a usual way using a basic guideline. The primary outcome is mean hourly fluid intake from the time of randomisation until the morning of day 2 after randomisation. Secondary outcomes include adherence to the fluid guidelines and fluid balance
Interventions
The intervention is a conservative fluid practice guideline, regarding the use intravenous fluids in adult patients who are admitted to ICU. The intention to minimise overall fluid exposure such that patients in this group will consistently receive an amount of fluid in the lower range of usual fluid exposure in ICU. The study procedures will continue until the patient is discharged from ICU or dies..
The guideline is categorised into 5 areas: maintenance fluid, replacement of ongoing fluid los
The intervention is a conservative fluid practice guideline, regarding the use intravenous fluids in adult patients who are admitted to ICU. The intention to minimise overall fluid exposure such that patients in this group will consistently receive an amount of fluid in the lower range of usual fluid exposure in ICU. The study procedures will continue until the patient is discharged from ICU or dies.. The guideline is categorised into 5 areas: maintenance fluid, replacement of ongoing fluid losses, bolus (resuscitation) fluid, drug and other infusions, and enteral nutrition. Maintenance fluid in the intervention group will be 0.5 ml/kg/hr. Fluid resuscitation boluses will be 250 ml in the intervention group. The study will accommodate and report deviations from the guideline where this is opted into by clinicians; adherence to the guideline will otherwise be encouraged as much as possible. Replacement of fluid losses will be prescribed separately to maintenance fluid in the conservative fluid guideline group. Fluids used for drug administration will be minimised by encouraging use of any existing local instructions for this purpose but will not be mandated or altered by the study. The intervention group guideline will prompt ICU staff to consider higher caloric density enteral feeds but this will not be mandated. The guideline will be implemented by research staff via education of ICU staff. Unit-wide education sessions will be held for registrars, residents and nursing at the commencement of the study period. Staff caring for patients who are randomised will be detailed personally by research staff and provided with the guideline. Laminated card copies of the guideline will be attached to the bed area for patients who are in the study. The guideline was developed by the authors of the study who are senior practicing Australian ICU clinicians (medical and nursing) with scientific experience in this area. The guideline development was also informed by a survey of more than 400 ICU clinicians in Australia concerning their beliefs and usual fluid practices. A synopsis of the fluid guideline is attached to the ANZCTR registration form.
Sponsors
The George Institute for Global Health
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
1. The treating ICU team expects the patient will continue to require management in the ICU on the day after tomorrow 2. Patient has an arterial line or placement is imminent 3. Less than 12 hours since ICU admission
Exclusion criteria
1. Age less than 18 years 2. Patient has been admitted to intensive care for treatment of burns 3. Patient has been admitted to intensive care for treatment of liver failure 4. Patient has been admitted to intensive care immediately following solid organ transplantation 5. Patient has been admitted to intensive care immediately following cardiac or lung surgery 6. Patient has been admitted to intensive care immediately following subarachnoid haemorrhage or traumatic brain injury 7. Patient has been admitted to a neurosurgical intensive care unit 8. Documented limits pertaining to end-of life management, or expectation of this in the following 48 hours 9. Women who are pregnant 10. Patients or persons responsible who are unable to read and understand the information and opt-out (English language) brochure provided for the study
Outcome results
None listed