An Assessment of Pulse Pressure Variation to Guide Fluid Therapy in Cardiac Surgery Patients

This study is not yet open for participant recruitment.

Verified September 2012 by Austin Health

Sponsor:

Information provided by (Responsible Party):

Rinaldo Bellomo, Austin Health

ClinicalTrials.gov Identifier:

NCT01681758

First received: September 6, 2012

Last updated: September 10, 2012

Last verified: September 2012

History of Changes

Purpose

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

Condition	Intervention	Phase
Cardiac Surgery	Other: IV fluid according to PPV Other: fluids according to standard care	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Before-and-after Assessment of Pulse Pressure Variation Guided Fluid Therapy in Cardiac Surgery Patients Receiving Mandatory Mechanical Ventilation

Resource links provided by NLM:

MedlinePlus related topics: Heart Surgery

U.S. FDA Resources

Further study details as provided by Austin Health:

Primary Outcome Measures:

Mean amount of fluid given in the first 24 hours after surgery [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
all intravenous fluid administered

Secondary Outcome Measures:

Physiological outcome [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
Blood lactate

Other Outcome Measures:

Physiological outcome [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
cardiac index

Estimated Enrollment:	100
Study Start Date:	September 2012
Estimated Study Completion Date:	April 2013
Estimated Primary Completion Date:	April 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: PPV use PPV to guide fluid therapy	Other: IV fluid according to PPV intravenous fluids
Placebo Comparator: standard care fluids according to standard care	Other: fluids according to standard care

Detailed Description:

The investigators will study patients after cardiac surgery
The investigators will collect data on standard care in pre-intervention population
The investigators will collect demographic and clinical data
The investigators will collect biochemical data in the first 24 hours after surgery
The investigators will collect biochemical, physiological and clinical outcome data
The investigators will compare the standard care and intervention period data

Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

immediately after ICU admission after cardiac surgery
mandatory mechanical ventilation -

Exclusion Criteria:

Pressure support ventilation
ECMO
Intra-aortic balloon counterpulsation

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01681758

Locations

Australia, Victoria
Austin Hospital	Not yet recruiting
Melbourne, Victoria, Australia, 3079
Contact: Rinaldo Bellomo, MD 61394965992 rinaldo.bellomo@austin.org.au
Contact: Glenn Eastwood, RN glenn.eastwood@austin.org.au
Principal Investigator: Rinaldo Bellomo, MD

Sponsors and Collaborators

Austin Health

More Information

No publications provided

Responsible Party:	Rinaldo Bellomo, Director of ICU Research, Austin Health
ClinicalTrials.gov Identifier:	NCT01681758 History of Changes
Other Study ID Numbers:	AICU2012-007
Study First Received:	September 6, 2012
Last Updated:	September 10, 2012
Health Authority:	Australia: Human Research Ethics Committee

Keywords provided by Austin Health:

cardiac surgery
Pulse pressure variation
intravenous fluids

ClinicalTrials.gov processed this record on May 21, 2013

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