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

September 6, 2012
July 9, 2013
January 2012
April 2013   (final data collection date for primary outcome measure)
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
Mean amount of fluid given in the first 24 hours after surgery [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
all intravenous fluid adminsitered
Complete list of historical versions of study NCT01681758 on ClinicalTrials.gov Archive Site
Physiological outcome [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
Blood lactate
Same as current
Physiological outcome [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
cardiac index
Same as current
 
An Assessment of Pulse Pressure Variation to Guide Fluid Therapy in Cardiac Surgery Patients
A Before-and-after Assessment of Pulse Pressure Variation Guided Fluid Therapy in Cardiac Surgery Patients Receiving Mandatory Mechanical Ventilation

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

  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
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Cardiac Surgery
  • Other: IV fluid according to PPV
    intravenous fluids
  • Other: fluids according to standard care
  • Active Comparator: PPV
    use PPV to guide fluid therapy
    Intervention: Other: IV fluid according to PPV
  • Placebo Comparator: standard care
    fluids according to standard care
    Intervention: Other: fluids according to standard care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
104
April 2013
April 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT01681758
AICU2012-007
No
Rinaldo Bellomo, Austin Health
Austin Health
Not Provided
Not Provided
Austin Health
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP