Hemodynamic therapy in abdominal surgery

Phase 1

• Conditions: - Hemodynamic Instability- Cardiac Output- High Peroperative Complication; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2017-001479-22-ES
• Lead Sponsor: niversity Medical Center Hamburg-Eppendorf, Germany

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-04
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 380

Inclusion Criteria

- To provide high generalizability and representativeness the high number of patients with laparotomy and major surgical trauma is included into this study.
- Therefore, open visceral, urological, and gynecological surgery is covered by this study.
- Expected duration of surgery must be = 120 minutes and requirement of volume therapy needs to be expected = 2 liters.
- Risk for any postoperative complications needs to be =10% assessed by the ACS (American College of Surgery)- NSQUIP (National Surgical Quality Improvement Program) risk calculator.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 380
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Patients <18 years,
-Laparoscopic approach,
-Patients not having sinus rhythm,
-Patients having highly impaired left ventricular function (ejection fraction <30%) or severe aortic valve stenosis (aortic valve area <1 cm2, mean gradient >40 mmHg),
-Pregnant women,
-Emergency surgeries (surgery required within 24 hours),
-Primarily vascular surgery,
-Patients suffering from septic shock,
-Patients having phaeochromocytoma,
-Patients suffering from non-cardiac chest pain,
-Refusal of consent,
-Patients receiving palliative treatment only (likely to die within 6 months) and patients suffering from acute myocardial ischemia (within 30 days before randomization) are excluded from the study.
-Further, in case that clinicians intended to use cardiac output monitoring for clinical reasons patients should also not be included in the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified