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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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 - Fluid responsiveness will be determined by any increase in cardiac output (continuous outcome) or by a 10-15% increase in cardiac output (dichotomous outcome) following bolus volume expansion
Timepoint [1] 0 0
Approximately 30 minutes
Primary outcome [2] 0 0
Volume management responsiveness - Responders will be defined as patients with an improvement (change towards normal physiological values) following cumulative volume expansion in any variable(s) used to assess oxygen delivery/consumption balance
Timepoint [2] 0 0
Approximately 6 hours
Secondary outcome [1] 0 0
Morbidity - Use and extent of measures to support organ function such as mechanical ventilation, mechanical and pharmacological cardiovascular interventions, renal replacement therapy whilst admitted to ICU as well as length of admission to ICU.
Timepoint [1] 0 0
At ICU discharge, an average of 4 days
Secondary outcome [2] 0 0
Mortality - Vital status censored at discharge from ICU and hospital
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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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/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. Review.
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
Other publications