Influence of perioperative HES 130/04 adminstration on postoperative complications:A prospective randomized trial in patients undergoing colorectal surgery.
- Conditions
- 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
- Registration Number
- EUCTR2008-001561-28-DE
- Lead Sponsor
- Klinik für Anästhesiologie und Operative Intensivmedizin Klinikum Ludwigshafen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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<br>;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).
- Secondary Outcome Measures
Name Time Method