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Intraoperative Fluid Management Based on Arterial Pulse Pressure Variation During High-Risk Surgery

This study has been terminated.
(significant reduction in length of hospital stay (primary endpoint))
Sponsor:
ClinicalTrials.gov Identifier:
NCT00479011
First Posted: May 25, 2007
Last Update Posted: May 25, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Santa Casa de Passos
  Purpose

Hypovolaemia and tissue hypoperfusion can pass undetected during and after major surgery. The resulting systemic inflammatory response and organ dysfunction, often not clinically apparent for several days, may lead to increased morbidity and mortality and prolonged hospital stay.

In this regard, intraoperative optimization of circulatory status by volume loading has been shown to improve the outcome of patients undergoing high-risk surgery.

Indeed, several reports (1-7) have shown that monitoring and maximizing stroke volume by volume loading (until stroke volume reaches a plateau, actually the plateau of the Frank-Starling curve) during high-risk surgery decreases the incidence of post-operative complications and the length of hospital stay.

Unfortunately, this strategy has required so far the measurement of stroke volume by a cardiac output monitor, as well as a specific training period for the operators (8), and hence is not applicable in many institutions as well as in many countries.

The arterial pulse pressure variation (∆PP) induced by mechanical ventilation is known to be a very accurate predictor of fluid responsiveness, i.e. of the position on the preload/stroke volume relationship (Frank-Starling curve) (9).

By increasing cardiac preload, volume loading induces a rightward shift on the preload/stroke volume relationship and hence a decrease in ∆PP. Patients who have reached the plateau of the Frank-Starling relationship can be identified as patients in whom ∆PP is low (9).

Therefore, the clinical and intraoperative goal of “maximizing stroke volume by volume loading” can be achieved simply by minimizing ∆PP.

We designed the present study to investigate whether monitoring and minimizing ∆PP by volume loading during high-risk surgery may improve post-operative outcome and decrease the duration of post-operative hospital stay.


Condition Intervention
Surgery Procedure: fluid management based on arterial pulse pressure variation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Supportive Care
Official Title: Intraoperative Fluid Management Based on Arterial Pulse Pressure Variation During High-Risk Surgery

Further study details as provided by Santa Casa de Passos:

Primary Outcome Measures:
  • The primary outcome measure is the duration of postoperative hospital stay. [ Time Frame: at days 1,2, and 5, as well as at ICU discharge, and hospital discharge. ]

Secondary Outcome Measures:
  • Number of post-operative complications, duration of mechanical ventilation, duration of ICU stay [ Time Frame: Post-opertaive days 1,2,5; ICU discharge; hospital discharge ]

Enrollment: 33
Study Start Date: September 2005
Study Completion Date: January 2006
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Medico-surgical pre-operative decision of post-operative ICU admission (because of co-morbidities or/and the surgical procedure)
  • Age > 18 yr
  • Elective surgery

Exclusion criteria:

  • No informed consent
  • Cardiac arrhythmias
  • Body mass index > 40
  • Patients undergoing surgery with an open thorax
  • Patients undergoing neurosurgery
  • Enrolment in any other protocol
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00479011


Locations
Brazil
Santa Casa de Misericordia de Passos
Passos, Minas Gerais, Brazil, 37900 000
Sponsors and Collaborators
Santa Casa de Passos
Investigators
Principal Investigator: Marcel Lopes, Rezende Santa Casa de Misericordia de Passos
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00479011     History of Changes
Other Study ID Numbers: marcelrlopes
First Submitted: May 24, 2007
First Posted: May 25, 2007
Last Update Posted: May 25, 2007
Last Verified: May 2007

Keywords provided by Santa Casa de Passos:
fluid management
arterial pulse pressure variation
high-risk surgery