NCT01681758

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2012

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 10, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

July 11, 2013

Status Verified

July 1, 2013

Enrollment Period

1.2 years

First QC Date

September 6, 2012

Last Update Submit

July 9, 2013

Conditions

Cardiac Surgery

Keywords

cardiac surgeryPulse pressure variationintravenous fluids

Outcome Measures

Primary Outcomes (1)

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

    all intravenous fluid administered

    24 hours

Secondary Outcomes (1)

  • Physiological outcome

    24 hours

Other Outcomes (1)

  • Physiological outcome

    24 hours

Study Arms (2)

PPV

ACTIVE COMPARATOR

use PPV to guide fluid therapy

Other: IV fluid according to PPV

standard care

PLACEBO COMPARATOR

fluids according to standard care

Other: fluids according to standard care

Interventions

IV fluid according to PPVOTHER

intravenous fluids

PPV
fluids according to standard careOTHER
standard care

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • immediately after ICU admission after cardiac surgery
  • mandatory mechanical ventilation -

You may not qualify if:

  • Pressure support ventilation
  • ECMO
  • Intra-aortic balloon counterpulsation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Austin Hospital

Melbourne, Victoria, 3079, Australia

Location

Related Publications (1)

  • 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.

    PMID: 25220528DERIVED

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of ICU Research

Study Record Dates

First Submitted

September 6, 2012

First Posted

September 10, 2012

Study Start

January 1, 2012

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

July 11, 2013

Record last verified: 2013-07

Locations

AU(1)