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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/NCT01681758




Registration number
NCT01681758
Ethics application status
Date submitted
6/09/2012
Date registered
10/09/2012
Date last updated
11/07/2013

Titles & IDs
Public title
An Assessment of Pulse Pressure Variation to Guide Fluid Therapy in Cardiac Surgery Patients
Scientific title
A Before-and-after Assessment of Pulse Pressure Variation Guided Fluid Therapy in Cardiac Surgery Patients Receiving Mandatory Mechanical Ventilation
Secondary ID [1] 0 0
AICU2012-007
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiac Surgery 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - IV fluid according to PPV
Other interventions - fluids according to standard care

Active Comparator: PPV - use PPV to guide fluid therapy

Placebo Comparator: standard care - fluids according to standard care


Other interventions: IV fluid according to PPV
intravenous fluids

Other interventions: fluids according to standard care
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mean amount of fluid given in the first 24 hours after surgery
Timepoint [1] 0 0
24 hours
Secondary outcome [1] 0 0
Physiological outcome
Timepoint [1] 0 0
24 hours

Eligibility
Key inclusion criteria
1. immediately after ICU admission after cardiac surgery

2. mandatory mechanical ventilation -
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Pressure support ventilation

2. ECMO

3. Intra-aortic balloon counterpulsation

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2013
Sample size
Target
Accrual to date
Final
104
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Austin Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3079 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Austin Health
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
We aim to test the hypothesis that fluid therapy based on pulse pressure variation (PPV) in
patients after cardiac surgery who are mechanically ventilated leads to a significant
decrease in the amount of fluid given to such patients in the first 24 hours after surgery
Trial website
https://clinicaltrials.gov/ct2/show/NCT01681758
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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/NCT01681758