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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rinaldo Bellomo, Austin Health
ClinicalTrials.gov Identifier:
NCT01681758
First received: September 6, 2012
Last updated: July 9, 2013
Last verified: July 2013
  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:


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


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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Australia, Victoria
Austin Hospital
Melbourne, Victoria, Australia, 3079
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: July 9, 2013
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 July 26, 2014