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

NCT00479011 | Terminated DMC

• 1 other identifier: marcelrlopes
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Surgery

Keywords

fluid management; arterial pulse pressure variation; high-risk surgery

Outcome Measures

Primary Outcomes (1)

• The primary outcome measure is the duration of postoperative hospital stay.

  at days 1,2, and 5, as well as at ICU discharge, and hospital discharge.

Secondary Outcomes (1)

• Number of post-operative complications, duration of mechanical ventilation, duration of ICU stay

  Post-opertaive days 1,2,5; ICU discharge; hospital discharge

Interventions

fluid management based on arterial pulse pressure variation PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• No informed consent
• Cardiac arrhythmias
• Body mass index \> 40
• Patients undergoing surgery with an open thorax
• Patients undergoing neurosurgery
• Enrolment in any other protocol

Sponsors & Collaborators

• Santa Casa de Passos: lead

Study Sites (1)

Santa Casa de Misericordia de Passos

Passos, Minas Gerais, 37900 000, Brazil

Location

Related Publications (1)

• Lopes MR, Oliveira MA, Pereira VO, Lemos IP, Auler JO Jr, Michard F. Goal-directed fluid management based on pulse pressure variation monitoring during high-risk surgery: a pilot randomized controlled trial. Crit Care. 2007;11(5):R100. doi: 10.1186/cc6117.

  PMID: 17822565 DERIVED

Study Officials

• Marcel Lopes, Rezende

  Santa Casa de Misericordia de Passos

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 24, 2007
• First Posted: May 25, 2007
• Study Start: September 1, 2005
• Study Completion: January 1, 2006
• Last Updated: May 25, 2007

Record last verified: 2007-05

Locations

BR (1)