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

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ClinicalTrials.gov Identifier: NCT01681758
Recruitment Status : Completed
First Posted : September 10, 2012
Last Update Posted : July 11, 2013
Sponsor:
Information provided by (Responsible Party):
Rinaldo Bellomo, Austin Health

Tracking Information
First Submitted Date  ICMJE September 6, 2012
First Posted Date  ICMJE September 10, 2012
Last Update Posted Date July 11, 2013
Study Start Date  ICMJE January 2012
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 10, 2012)
Mean amount of fluid given in the first 24 hours after surgery [ Time Frame: 24 hours ]
all intravenous fluid administered
Original Primary Outcome Measures  ICMJE
 (submitted: September 7, 2012)
Mean amount of fluid given in the first 24 hours after surgery [ Time Frame: 24 hours ]
all intravenous fluid adminsitered
Change History Complete list of historical versions of study NCT01681758 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 7, 2012)
Physiological outcome [ Time Frame: 24 hours ]
Blood lactate
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 7, 2012)
Physiological outcome [ Time Frame: 24 hours ]
cardiac index
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE An Assessment of Pulse Pressure Variation to Guide Fluid Therapy in Cardiac Surgery Patients
Official Title  ICMJE A Before-and-after Assessment of Pulse Pressure Variation Guided Fluid Therapy in Cardiac Surgery Patients Receiving Mandatory Mechanical Ventilation
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
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cardiac Surgery
Intervention  ICMJE
  • Other: IV fluid according to PPV
    intravenous fluids
  • Other: fluids according to standard care
Study Arms  ICMJE
  • 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
Publications * Suzuki S, Woinarski NC, Lipcsey M, Candal CL, Schneider AG, Glassford NJ, Eastwood GM, Bellomo R. Pulse pressure variation-guided fluid therapy after cardiac surgery: a pilot before-and-after trial. J Crit Care. 2014 Dec;29(6):992-6. doi: 10.1016/j.jcrc.2014.07.032. Epub 2014 Aug 7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 9, 2013)
104
Original Estimated Enrollment  ICMJE
 (submitted: September 7, 2012)
100
Actual Study Completion Date  ICMJE April 2013
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01681758
Other Study ID Numbers  ICMJE AICU2012-007
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rinaldo Bellomo, Austin Health
Study Sponsor  ICMJE Austin Health
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Austin Health
Verification Date July 2013

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