Adult patients (>18 years) of both gender undergoing elective colorectal surgery (hemicolectomy left/right, sigmoid colectomy, rectal resection/amputation) without concomitant resection of liver metastasis
Conditions
Interventions
Trade Name: Volulyte
Product Name: Volulyte
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: 64678.00.00
Current Sponsor code: HES08
Other descriptive name: Volulyte
Concentration unit:
Sponsors
Klinik für Anästhesiologie und Operative Intensivmedizin Klinikum Ludwigshafen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adult patients (>18 years) of both gender undergoing elective colorectal surgery (hemicolectomy left/right, sigmoid colectomy, rectal resection/amputation) without concomitant resection of liver metastasis 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patient is not able or willing to sign informed consent 2. Patient is already participating in another clincal trial 3. Emergency surgery 4. Laparoscopic surgery 5. Pregnant or breastfeeding women 6. Hyperhydratation 7. Renal failure 8. Patients undergoing dialysis 9. Intracranial bleeding 10. Hypernatremia, Hyperchloremia 11. Hyperkaliemia 12. Hypercalcemia 13. Metabolic alcalosis 14. Sever edema 15. Known allergies against Hydroxyethylstarch 16. women of childbearing potential 17. women of childbearing potential using contraception 18. Hypermagnesemia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the influence of perioperative administration of HES 130/0,4 (Volulyte®) versus Sterofundin ISO solution on postoperative complications. The primary outcome variable is the occurence of postoperative complications (tissue healing complications, bleeding, postoperative nausea and vomiting, sepsis, cardiac and pulmonary complications). ;Secondary Objective: To investigate the influence of perioperative administration of HES 130/0,4 (Volulyte®) versus Sterofundin ISO solution on: organ function (kidney, liver, endothelium, cardiac, pulmonary), mortality, use of concomitant medication ;Primary end point(s): The primary outcome variable is the occurence of postoperative complications (tissue healing complications, bleeding, postoperative nausea and vomiting, sepsis, cardiac and pulmonary complications). | — |
Countries
Germany
Outcome results
None listed