Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02841943




Registration number
NCT02841943
Ethics application status
Date submitted
15/07/2016
Date registered
22/07/2016
Date last updated
21/03/2017

Titles & IDs
Public title
Fluid Responsiveness After CArdiac Surgery Study
Scientific title
Fluid Responsiveness After Cardiac Surgery (FRACAS) Study
Secondary ID [1] 0 0
LIVICU001
Universal Trial Number (UTN)
Trial acronym
FRACAS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critically Ill 0 0
Hypovolemia 0 0
Condition category
Condition code
Blood 0 0 0 0
Other blood disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Fluid bolus responsiveness
Timepoint [1] 0 0
Approximately 30 minutes
Primary outcome [2] 0 0
Volume management responsiveness
Timepoint [2] 0 0
Approximately 6 hours
Secondary outcome [1] 0 0
Morbidity
Timepoint [1] 0 0
At ICU discharge, an average of 4 days
Secondary outcome [2] 0 0
Mortality
Timepoint [2] 0 0
Up to 3 months

Eligibility
Key inclusion criteria
- Admitted following elective cardiac surgery

- Adult (>18 years of age)

- Pulmonary artery, central venous and arterial catheters inserted
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Emergency Patients (surgery immediately or within 12 hours of admission to hospital)

- Children (< 18 years of age)

- Patients admitted to ICU with ongoing extracorporeal circulatory support

- Patients re-admitted to ICU within same index hospital admission

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2016
Sample size
Target
Accrual to date
Final
102
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Intensive Care Unit, Liverpool Hospital, South Western Sydney Local Health District - Liverpool
Recruitment postcode(s) [1] 0 0
1871 - Liverpool

Funding & Sponsors
Primary sponsor type
Other
Name
South West Sydney Local Health District
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Study Design: Prospective observational study

Study Location: Liverpool Hospital Intensive Care Unit, South Western Sydney Local Health
District, Sydney, Australia.

Target study size: 100 patients

Ethics: Approved by the local Human Research and Ethics Council (HREC) at Liverpool Hospital
(LPOOL) as a Low Negligible Risk (LNR) project [HREC/LNR/14/LPOOL/295, HREC/LNR/15/LPOOL47,
HREC/LNR/14/LPOOL/150]

Participants: Post cardiac surgical patients admitted to the Intensive Care Unit between
March-October 2016

Aims:

1. to determine the descriptive and predictive value of variables (outlined below) related
to oxygen delivery/consumption in regards to the effects of intravascular volume
expansion

2. to assess correlations between central and peripheral variables (outlined below)
relevant to oxygen delivery/consumption

3. to assess correlations between a set of variables (outline below) and patient centred
outcomes in ICU and in hospital

Main variables collected:

1. Tissue oxygen saturation by peripheral Near-Infrared Spectroscopy (NIRS)

2. Common carotid arterial Doppler

3. Arterial/mixed venous/central venous blood gas analyses

4. Haemodynamic parameters

5. Organ support measures

Data collection time points:

1. ICU admission (within 30 minutes)

2. Before administration of a fluid bolus

3. After administration of a fluid bolus

4. 6 hours after ICU admission

5. Morning of first postoperative day (12-24 hours)

Outcome measures:

1. the response to intravascular volume expansion

2. ICU mortality, morbidity and length of stay and hospital mortality and length of stay

Data analysis:

1. Clinical data are collected bedside using an electronic case record form

2. Descriptive statistics

3. Paired and unpaired comparative

4. Correlative and predictive statistics
Trial website
https://clinicaltrials.gov/ct2/show/NCT02841943
Trial related presentations / publications
Gupta K, Sondergaard S, Parkin G, Leaning M, Aneman A. Applying mean systemic filling pressure to assess the response to fluid boluses in cardiac post-surgical patients. Intensive Care Med. 2015 Feb;41(2):265-72. doi: 10.1007/s00134-014-3611-2. Epub 2015 Jan 8.
Sondergaard S, Parkin G, Aneman A. Central venous pressure: soon an outcome-associated matter. Curr Opin Anaesthesiol. 2016 Apr;29(2):179-85. doi: 10.1097/ACO.0000000000000305.
Rangappa R, Sondergaard S, Aneman A. Improved consistency in interpretation and management of cardiovascular variables by intensive care staff using a computerised decision-support system. Crit Care Resusc. 2014 Mar;16(1):48-53.
Public notes

Contacts
Principal investigator
Name 0 0
Anders Aneman, MD, PhD
Address 0 0
Liverpool Hospital, South Western Sydney Local Health District
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02841943