Intraoperative Fluid Management Based on Arterial Pulse Pressure Variation During High-Risk Surgery
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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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Supportive Care |
| Official Title: | Intraoperative Fluid Management Based on Arterial Pulse Pressure Variation During High-Risk Surgery |
- 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. ]
- 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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| Brazil | |
| Santa Casa de Misericordia de Passos | |
| Passos, Minas Gerais, Brazil, 37900 000 | |
| Principal Investigator: | Marcel Lopes, Rezende | Santa Casa de Misericordia de Passos |
More Information
No publications provided by Santa Casa de Passos
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00479011 History of Changes |
| Other Study ID Numbers: | marcelrlopes |
| Study First Received: | May 24, 2007 |
| Last Updated: | May 24, 2007 |
| Health Authority: | Brazil: National Committee of Ethics in Research |
Keywords provided by Santa Casa de Passos:
|
fluid management arterial pulse pressure variation high-risk surgery |
ClinicalTrials.gov processed this record on May 23, 2013