To determine whether early goal-directed therapy, aimed at optimizing cardiac output measured by arterial waveform analysis, improves outcome in high-risk, abdominal surgery.
ID
Source
Brief title
Condition
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is the number of major complications in the first 30 days
after the operation.
Secondary outcome
Secundary outcome parameters are other complications, length of hospital and
ICU/PACU stay, the total amount of fluid and inotropics administrated, and
vital functions during surgery and in the OR and ICU/PACU.
Background summary
Early goal-directed therapy (EGDT) to optimize tissue oxygen delivery has shown
to improve outcome in high-risk surgery. However, difficulty in the practical
conduct of advanced hemodynamic monitoring limits the introduction of EGDT in
routine practice. The PiCCO and Vigileo systems provide easy, minimal invasive,
continuous cardiac output measurement using arterial waveform analysis, and
could therefore guide EGDT.
Study objective
To determine whether early goal-directed therapy, aimed at optimizing cardiac
output measured by arterial waveform analysis, improves outcome in high-risk,
abdominal surgery.
Study design
Multi-center, randomized controlled, clinical study.
Intervention
Early goal-directed therapy, based on stroke volume variation measurement and
passive leg raising, guiding fluid and inotropic therapy to keep cardiac output
above a preset, age-dependent threshold value.
Study burden and risks
In the intervention group, cardiac output, and stroke volume variation are
measured with PiCCO or Vigileo. These systems use the arterial and/or central
venous lines that are routinely placed in high-risk surgical patients.
Treatment with fluid challenges and inotropic support, is routine practice in
the peri-operative period in high-risk surgery. As a result, the EGDT algorithm
used in this study is not associated with an increased burden to health.
P. Debyelaan 25
Maastricht 6229 HX
NL
P. Debyelaan 25
Maastricht 6229 HX
NL
Listed location countries
Age
Inclusion criteria
Included will be patients undergoing the following elective operations, irrespective of their their ASA classification:
- esophagectomy
- pancreaticoduodenectomy
- open abdominal aorta aneurysm (AAA) repair
- major abdominal resections for soft tissue malignancy, in which post-operative observation in the ICU or PACU is necessary
In addition, patients with ASA physical status III or IV undergoing the following operations are included, if post-operative observation in the ICU of PACU is necessary:
- gastrectomy
- colorectal resections for carcinoma
- other extended upper or lower abdominal surgery
Exclusion criteria
Exclusion criteria are:
- age < 18 years
- cardiac arrhythmias
- emergency surgery
- contraindication for passive leg raising in the entire postoperative period
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL32416.041.10 |
| OMON | NL-OMON24432 |