Conservative use of intravenous fluid in critically ill adults - pilot study

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12616001670460
• Date of registration: 05/12/2016
• Prospective Registration: Yes
• Primary sponsor: The George Institute for Global Health
• Public title: Conservative use of intravenous fluid in critically ill adults - pilot study
• Scientific title: Randomised controlled feasibility study of conservative versus usual fluid management in critically ill adults
• Date of first enrolment: 01/03/2018
• Target sample size: 100
• Recruitment status: Withdrawn
• URL: https://anzctr.org.au/ACTRN12616001670460.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Australia

Contacts

• Name: A/Prof David Gattas

• Name: A/Prof David Gattas

Key inclusion & exclusion criteria

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


Age minimum: 18 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Critical illness;Shock;
Critical illness
Shock

Other - Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention(s)

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 guidelin

Primary Outcome(s)

Mean hourly fluid intake. This will be collected by ICU research staff who will review the daily flowsheet in the ICU.[From the time of randomisation until 08:00 on the morning of day 2 post-randomisation]

Secondary Outcome(s)

Exploratory outcome: peak creatinine. This will be collected from the electronic pathology record.[until time of ICU discharge or death]

Median hourly fluid intake. This will be collected by ICU research staff who will review the daily flowsheet in the ICU.[from the time of randomisation until 08:00 on the morning of day 2 post-randomisation]

Exploratory outcome: lowest ratio of partial pressure of oxygen in arterial blood (PaO2) to fraction of inspired oxygen (FiO2). This will be collected by ICU research staff from the medical record[until time of ICU discharge or death]

Cumulative fluid balance. This will be collected by ICU research staff who will review the daily flowsheet in the ICU.[From the time of ICU admission until 08:00 on the morning of day 2 and day 7 post-randomisation (or ICU discharge if earlier than day 7)]

Feasibility outcome - reasons for nonadherence to guideline. This will be collected as free text by ICU research staff from a convenience sample of staff [until time of ICU discharge or death]

Exploratory outcome: ICU length of stay. This will collected from the medical record by ICU research staff.[until time of ICU discharge or death]

Exploratory outcome: ventilator free hours. This will be collected from the ICU daily flowsheet.[until time of ICU discharge or death]

Feasibility outcome - adherence to guideline: count of episodes of deviation from the fluid guideline, bolus fluid. This will be collected but ICU research staff using the ICU flowsheet (medical record)[until time of ICU discharge or death]

Exploratory outcome: mortality. This will collected from the medical record by ICU research staff.[At ICU and hospital dicharge]

Exploratory outcome: urine output. This will be collected by ICU research staff who will review the daily flowsheet in the ICU.[At ICU discharge]

Feasibility outcome - adherence to guideline: count of episodes of deviation from the fluid guideline, maintenance fluid rate. This will be collected but ICU research staff using the ICU flowsheet (medical record)[Until time of ICU discharge or death]

Total fluid intake. This will be collected by ICU research staff who will review the daily flowsheet in the ICU.[From the time of randomisation until 08:00 on the morning of day 7 post-randomisation (or ICU discharge if earlier than day 7)]

Cumulative fluid balance. This will be collected by ICU research staff who will review the daily flowsheet in the ICU.[From the time of randomisation until 08:00 on the morning of day 2 and day 7 post-randomisation (or ICU discharge if earlier than day 7)]

Secondary ID(s)

None

Source(s) of Monetary Support

Intensive Care Foundation

Ethics review

Status: Not approved
Approval date:
Contact:

Sydney Local Health District Ethics Review Committee (RPAH Zone)