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Multi-center Trial of Goal-directed Fluid Management Based on Pulse Pressure Variation Monitoring

NCT03128190 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 256

Last updated 2017-04-25

No results posted yet for this study

Summary

Background: Intraoperative fluid therapy guided by mechanical ventilation-induced pulse-pressure variation (PPV) may improve outcomes after major surgery. It was tested this hypothesis in a multi-center study.

Methods: The patients were included in two periods: a first control period (control group; n=147) in which intraoperative fluids were given according to clinical judgment. After a training period, intraoperative fluid management was titrated to maintain PPV\< 10% in 109 surgical patients (PPV group). It was performed 1:1 propensity score matching to ensure the groups were comparable with regard to age, weight, duration of surgery, and type of operation. The primary endpoint was postoperative hospital length of stay.

Conditions

  • Goal-directed Fluid Therapy
  • Hemodynamics Instability
  • High-risk Surgery
  • Pulse-pressure Variation
  • Postoperative Complications

Interventions

OTHER

Pulse pressure variation monitoring

fluids boluses of colloids were given to maintain continuously measured PPV at 10% or less

Sponsors & Collaborators

  • University of Sao Paulo

    collaborator OTHER

  • Hospital Padre Albino of Catanduva Medical School

    collaborator UNKNOWN

  • Federal University of São Paulo

    collaborator OTHER

  • Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-06-01
Primary Completion
2010-06-01
Completion
2010-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03128190 on ClinicalTrials.gov