Influence of early goal-directed therapy using arterial waveform cardiac output measurement in high-risk surgery

Influence of early goal-directed therapy using arterial waveform cardiac output measurement in high-risk surgery - EGDT in high-risk surgery

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON44010

Enrollment

542

Registered

2011-03-21

Start date

2012-05-22

Completion date

Unknown

Last updated

2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

high-risk surgery

Interventions

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

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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: Exclusion criteria are: - age

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the number of major complications in the first 30 days after the operation.	—

Secondary

Measure	Time frame
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.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)