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

July 9, 2013 updated by: Rinaldo Bellomo, Austin Health

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

104

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3079
        • Austin Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean amount of fluid given in the first 24 hours after surgery
Time Frame: 24 hours
all intravenous fluid administered
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physiological outcome
Time Frame: 24 hours
Blood lactate
24 hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physiological outcome
Time Frame: 24 hours
cardiac index
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Austin Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (ACTUAL)

April 1, 2013

Study Completion (ACTUAL)

April 1, 2013

Study Registration Dates

First Submitted

September 6, 2012

First Submitted That Met QC Criteria

September 7, 2012

First Posted (ESTIMATE)

September 10, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

July 11, 2013

Last Update Submitted That Met QC Criteria

July 9, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AICU2012-007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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