Steering of administration of intravenous fluids and vasoactive drugs towards set goals during surgery for removal of the esofagus because of cancer
Phase 1
- Conditions
- Anesthesia for esophageal resection because of malignancyTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Registration Number
- EUCTR2011-000254-39-SE
- Lead Sponsor
- Anestesi och Operationskliniken
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 65
Inclusion Criteria
Patients scheduled for elective esophageal resection because of malignancy without colon interposition
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 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 35
Exclusion Criteria
- ASA-class 4 or higher
- Signifikant aortic/mitral insufficiency
- Extensive hemodynamic monitoring planned excluding Invasive Arterial Blood Pressure, ElectroCardioGraphy, Central Venous Pressure and diuresis
- Contraindikations to artificila kolloids such as allergy, severe kidney/liverdisease or severe hypernatremia
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To test whether intraoperative fluid and catecholamin administration steered by stroke volume optimization measured by pulse contour analysis will result in fewer postoperative complications;Secondary Objective: To test whether intraoperative fluid and catecholamin administration steered by stroke volume optimization measured by pulse contour analysis will result in a shorter length of stay;Primary end point(s): Postoperative complications;Timepoint(s) of evaluation of this end point: 5 and 30 days post primary surgery
- Secondary Outcome Measures
Name Time Method Secondary end point(s): length of stay at ICU and total hospital<br>return of bowel function;Timepoint(s) of evaluation of this end point: 30 days post primary surgery