Surgery, Colorectal
Conditions
Keywords
goal-directed fluid optimization, hemodynamic optimization, crystalloid, colloid
Brief summary
The primary purpose of this study is to determine the effect of a balanced 6%hydroxyethyl starch 130/0.4 vs. a balanced crystalloid in colorectal surgery. The intraoperative fluid management will be given to optimize the stroke volume variation \<= 12%. The investigators hypothesize that patients in the intervention group will need less fluid administration be optimal hemodynamic stabilized.
Interventions
DRUGbalanced 6% hydroxyethylstarch 130/0.4
Fluid administration and optimization based on cardiac output findings during surgery.
Fluid administration and optimization based on cardiac output findings during surgery.
Sponsors
Fresenius Kabi
University Hospital Muenster
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients undergoing elective colorectal surgery * minimum age 18 years * informed consent
Exclusion criteria
* patients with severe cardiomyopathy or severe heart failure * history of coagulation disorders * intracranial hemorrhage * patients with severe cardiovascular or respiratory disorders * renal insufficiency * severe liver diseases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total amount of administered fluids | intraoperatively | Total amount of administered fluids intraoperatively that is necessary to keep patients optimal hemodynamic stabilized |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of surgery related complications | day 28 and 90 postoperatively |
Countries
Germany
Outcome results
None listed