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| ID | Type | Description | Link |
|---|---|---|---|
| PHRC 2006/1915 | Other Identifier | DHOS | |
| 2007/0723 | Other Identifier | sponsor |
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The purpose of this study is to determine whether intraoperative goal-directed fluid management (with goal = cardiac stroke volume maximization) based on respiratory-induced pulse pressure variation monitoring may improve outcome after intrabdominal surgery
Recent studies strongly suggest that intraoperative oesophageal doppler guided fluid management may improve outcome after intrabdominal surgery. In these studies, however, the number of patients was often small, and management in control groups as well as postoperative complications were usually not precisely defined. In addition, widespread use of oesophageal doppler cannot be advocated in routine surgery, and the strategy necessitates repeated volume loading. This may lead to unnecessary intravenous fluids which may be deleterious, and intraoperative fluid restriction has also been shown to improve clinical outcome. In this context, indices reflecting the hemodynamic changes during mechanical ventilation (the so-called "dynamic indices", and more specifically the respiratory-induced pulse pressure variation) have been shown to accurately predict fluid responsiveness in mechanically ventilated patients. Automated and continuous calculation of pulse pressure variation variation from standard peripheral (typically radial) arterial line has recently been validated. This study was thus designed to determine whether intraoperative goal-directed fluid management (with goal = cardiac stroke volume maximization) based on pulse pressure variation monitoring would improve outcome after intrabdominal surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Optimization | Experimental | volume optimization: continuous monitoring of the respiratory-induced arterial pulse pressure variation during surgery and systematic minimization to 10% or less by volume loading |
|
| control; standard volume administration | Active Comparator | standard volume administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| volume optimization | Other | Fluid management:
|
| Measure | Description | Time Frame |
|---|---|---|
| Total number of patients with complications | first 7 postoperative days |
| Measure | Description | Time Frame |
|---|---|---|
| total number of complications | first 7 postoperative days | |
| SOFA (Sequential Organ Failure Assessment) score | postoperative days 1 and 5 | |
| Time to initial passage of flatus and feces |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Benoit TAVERNIER, MD, PhD | University Hospital, Lille | Study Director |
| Benoit VALLET, MD, PhD | University Hospital, Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital | Amiens | 80054 | France | |||
| University Hospital |
| Type | Date | Date Unknown |
|---|---|---|
| Release | May 12, 2026 | |
| Reset | Jun 5, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 12, 2026 | Jun 5, 2026 |
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|
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| standard volume administration | Other | Fluid management:
|
|
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| postoperative |
| duration of stay in intensive care unit | postoperative |
| Duration of hospital stay | postoperative |
| death | in-hospital and postoperative day 28 |
| volumes of fluid administered | duration of surgery |
| Caen |
| 14033 |
| France |
| Département d'Anesthésie-Réanimation, Hôpital Estaing, CHU | Clermont-Ferrand | 63000 | France |
| University hospital Henri-Mondor | Créteil | 94010 | France |
| University Hospital | Lille | 59000 | France |
| University Hospital | Rouen | 76031 | France |