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

NCT ID: NCT01681758

Last Updated: 2013-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-04-30

Brief Summary

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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

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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

Conditions

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Cardiac Surgery

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PPV

use PPV to guide fluid therapy

Group Type ACTIVE_COMPARATOR

IV fluid according to PPV

Intervention Type OTHER

intravenous fluids

standard care

fluids according to standard care

Group Type PLACEBO_COMPARATOR

fluids according to standard care

Intervention Type OTHER

Interventions

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IV fluid according to PPV

intravenous fluids

Intervention Type OTHER

fluids according to standard care

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Austin Health

OTHER_GOV

Sponsor Role lead

Responsible Party

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Rinaldo Bellomo

Director of ICU Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Austin Hospital

Melbourne, Victoria, Australia

Site Status

Countries

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Australia

References

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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.

Reference Type DERIVED
PMID: 25220528 (View on PubMed)

Other Identifiers

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AICU2012-007

Identifier Type: -

Identifier Source: org_study_id

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