Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001644257p
Ethics application status
Submitted, not yet approved
Date submitted
17/09/2018
Date registered
4/10/2018
Date last updated
4/10/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Hemodynamic effects of warm vs cold resuscitation fluid in critically ill patients
Scientific title
A randomized control study to examine the hemodynamic effects of resuscitation fluid temperature (warm vs room temperature) in critically ill patients
Secondary ID [1] 295061 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
hypotension 308906 0
shock 308908 0
Condition category
Condition code
Cardiovascular 307811 307811 0 0
Other cardiovascular diseases
Emergency medicine 307812 307812 0 0
Resuscitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intensive Care patients meeting a predetermined criteria to receive a fluid bolus will be randomised into intervention (warmed) or control (room temperature) groups.

Patients in intervention group will receive a 500ml bolus of 4% albumin intravenously over 15 minutes, given through a fluid warmer at 38 degrees Celsius.
Intervention code [1] 301893 0
Treatment: Other
Comparator / control treatment
Intensive Care patients meeting a predetermined criteria to receive a fluid bolus will be randomised into intervention (warmed to 38 degrees Celsius) or control (room temperature 23 degrees Celsius) groups.

Patients in control group will receive a 500ml bolus of 4% albumin intravenously over 15 minutes, given at room temperature.
Control group
Active

Outcomes
Primary outcome [1] 307024 0
To measure the difference in change in stroke volume via transthoracic echocardiogaphy following room temperature vs warmed fluid bolus
Timepoint [1] 307024 0
30 minutely from administration of fluid bolus, for 2 hours.
Secondary outcome [1] 350412 0
Stroke work as calculated by stroke volume multiplied by central aortic pressure

Stroke volume will be measured by echocardiography. Central aortic pressure will be calculated indirectly using radial arterial waveform.
Timepoint [1] 350412 0
30 minutely for 2 hours from initiation of fluid bolus
Secondary outcome [2] 350414 0
Systemic vascular resistance. Calculated from echocardiographically measured cardiac output, mean arterial pressure and central venous pressure.
Timepoint [2] 350414 0
30 minutely for 2 hours from initiation of fluid bolus
Secondary outcome [3] 350415 0
Heart rate as measured by ECG, pulse oximeter and arterial blood pressure monitor.
Timepoint [3] 350415 0
30 minutely for 2 hours from initiation of fluid bolus
Secondary outcome [4] 350416 0
Mean arterial pressure as measured by arterial line.
Timepoint [4] 350416 0
30 minutely for 2 hours from initiation of fluid bolus
Secondary outcome [5] 350417 0
body temperature as measured by temperature probe
Timepoint [5] 350417 0
30 minutely for 2 hours from initiation of fluid bolus
Secondary outcome [6] 350418 0
Urine output measured hourly via indwelling urinary catheter bag
Timepoint [6] 350418 0
30 minutely for 2 hours from initiation of fluid bolus
Secondary outcome [7] 350419 0
Vasoactive agent requirement as recorded in standard ICU observation chart, the dose per hour of vasoactive agent required to maintain a target mean arterial pressure will be recorded.
Timepoint [7] 350419 0
30 minutely for 2 hours from initiation of fluid bolus
Secondary outcome [8] 350420 0
Blood lactate levels
Timepoint [8] 350420 0
30 minutely for 2 hours from initiation of fluid bolus

Eligibility
Key inclusion criteria
• Admitted to ICU
• Age 18 years or older
• Meeting clinical criteria for fluid bolus administration (one of the following):
o MAP <65mmHg
o HR >100bpm
o Urine output <0.5ml/kg/hr
o Lactate levels of >3mmol/dL
o Cardiac index <2.5L/min/m2
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Active bleeding requiring transfusion
• Haemoglobin level <70g/L
• Patients in whom death is considered imminent (within 24 hours)
• Receiving continuous renal replacement therapy (CRRT)
• Active temperature control
• Pregnancy
• Malignant hyperthermia
• Planned exit from ICU during 2 hour monitoring period
• Inability to obtain satisfactory echocardiographic images for cardiac output measurement

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis
Outcomes will be compared after log transformation where appropriate. Comparisons will be made using t-test and analysis of variance for repeated measures or Wilcoxon rank-signed test and Kruskal-Wallis according to the underlying distribution for continuous data and Chi-square for categorical data. Analysis will be an on intention-to-treat basis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/02/2019
Actual
Date of last participant enrolment
Anticipated
3/08/2020
Actual
Date of last data collection
Anticipated
3/08/2020
Actual
Sample size
Target
54
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 11614 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 23658 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 299643 0
Charities/Societies/Foundations
Name [1] 299643 0
Intensive Care Foundation
Country [1] 299643 0
Australia
Primary sponsor type
Hospital
Name
Flinders Medical Centre
Address
Flinders Dr, Bedford Park SA 5042
Country
Australia
Secondary sponsor category [1] 300232 0
None
Name [1] 300232 0
Address [1] 300232 0
Country [1] 300232 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 300540 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 300540 0
Ethics committee country [1] 300540 0
Australia
Date submitted for ethics approval [1] 300540 0
17/09/2018
Approval date [1] 300540 0
Ethics approval number [1] 300540 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 83998 0
Dr Simon Tan
Address 83998 0
Intensive and Critical Care Unit, Flinders Medical Centre, Flinders Dr, Bedford Park SA 5042
Country 83998 0
Australia
Phone 83998 0
+61421347522
Fax 83998 0
Email 83998 0
[email protected]
Contact person for public queries
Name 83999 0
Simon Tan
Address 83999 0
Intensive and Critical Care Unit, Flinders Medical Centre, Flinders Dr, Bedford Park SA 5042
Country 83999 0
Australia
Phone 83999 0
+61421347522
Fax 83999 0
Email 83999 0
[email protected]
Contact person for scientific queries
Name 84000 0
Simon Tan
Address 84000 0
Intensive and Critical Care Unit, Flinders Medical Centre, Flinders Dr, Bedford Park SA 5042
Country 84000 0
Australia
Phone 84000 0
+61421347522
Fax 84000 0
Email 84000 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.