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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01681758
First Posted: September 10, 2012
Last Update Posted: July 11, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Rinaldo Bellomo, Austin Health
  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
Intervention Model: Single Group Assignment
Masking: None (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:


Further study details as provided by Rinaldo Bellomo, Austin Health:

Primary Outcome Measures:
  • Mean amount of fluid given in the first 24 hours after surgery [ Time Frame: 24 hours ]
    all intravenous fluid administered


Secondary Outcome Measures:
  • Physiological outcome [ Time Frame: 24 hours ]
    Blood lactate


Other Outcome Measures:
  • Physiological outcome [ Time Frame: 24 hours ]
    cardiac index


Enrollment: 104
Study Start Date: January 2012
Study Completion Date: April 2013
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:
  1. The investigators will study patients after cardiac surgery
  2. The investigators will collect data on standard care in pre-intervention population
  3. The investigators will collect demographic and clinical data
  4. The investigators will collect biochemical data in the first 24 hours after surgery
  5. The investigators will collect biochemical, physiological and clinical outcome data
  6. The investigators will compare the standard care and intervention period data
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. immediately after ICU admission after cardiac surgery
  2. mandatory mechanical ventilation -

Exclusion Criteria:

  1. Pressure support ventilation
  2. ECMO
  3. Intra-aortic balloon counterpulsation
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01681758


Locations
Australia, Victoria
Austin Hospital
Melbourne, Victoria, Australia, 3079
Sponsors and Collaborators
Austin Health
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Rinaldo Bellomo, Director of ICU Research, Austin Health
ClinicalTrials.gov Identifier: NCT01681758     History of Changes
Other Study ID Numbers: AICU2012-007
First Submitted: September 6, 2012
First Posted: September 10, 2012
Last Update Posted: July 11, 2013
Last Verified: July 2013

Keywords provided by Rinaldo Bellomo, Austin Health:
cardiac surgery
Pulse pressure variation
intravenous fluids