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CompletedNCT01681758Updated Jul 11, 2013

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

A Phase 2 interventional study of IV fluid according to PPV and fluids according to standard care in Cardiac Surgery, sponsored by Austin Health. Completed at 1 site in Australia. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2013-07-11.

Sponsored by Austin Health · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
104
Allocation
Non-randomized
Ages
18 Years to 90 Years
Sex
All
01

Study 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

Read the 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
02

Conditions studied

  • Cardiac Surgery

Keywords

  • cardiac surgery
  • Pulse pressure variation
  • intravenous fluids
03

In context

Lead sponsor

Austin Health is the lead sponsor of 41 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Pressure support ventilation
  2. ECMO
  3. Intra-aortic balloon counterpulsation
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
104 participants (actual)

Study arms

  • Active comparator
    PPV

    use PPV to guide fluid therapy

    Other: IV fluid according to PPV

  • Placebo comparator
    standard care

    fluids according to standard care

    Other: fluids according to standard care

Interventions

  • OtherIV fluid according to PPV

    intravenous fluids

  • Otherfluids according to standard care
06

What researchers measure

Primary outcomes

  1. Mean amount of fluid given in the first 24 hours after surgery

    all intravenous fluid administered

    Time frame: 24 hours

Secondary outcomes

  1. Physiological outcome

    Blood lactate

    Time frame: 24 hours

Other outcomes

  1. Physiological outcome

    cardiac index

    Time frame: 24 hours

07

Study locations

1 site
  • Austin Hospital
    Melbourne, Victoria 3079, Australia
08

References and documents

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. PubMed 25220528 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 11, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01681758
Lead sponsor
Austin Health
Responsible party
Rinaldo Bellomo (Director of ICU Research, Austin Health) — Principal investigator
First posted
Sep 10, 2012
Start date
Jan 2012
Primary completion
Apr 2013
Completion
Apr 2013
Last update
Jul 11, 2013

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.

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