Patients undergoing colorectal surgery MedDRA version: 14.1 Level: LLT Classification code 10040668 Term: Sigmoid hemicolectomy System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 14.1 Level: PT Classification code 10009879 Term: Colectomy total System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 14.1 Level: PT Classification code 10059848 Term: Proctocolectomy System Organ Class: 10042613 - Surgical and medical procedures MedDRA version:
Conditions
Interventions
Trade Name: Volulyte 6 % Infusionslösung
Pharmaceutical Form: Solution for infusion
CAS Number: 9005-27-0
Other descriptive name: HETASTARCH
Concentration unit: g/l gram(s)/litre
Concentration type: e
Sponsors
University Hospital Muenster
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients undergoing elective colorectal surgery with signed written informed consent - Age >= 18 years - Sinus rhythm 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 120 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: - patients younger than 18 years - women, who are pregnant or nursing - severe cardiamyopathy or severe heart failure - history of coagulation disorders - intracranial hemorrhage - patients with severe cardiovascular or respiratory disorders - renal insufficiency (creatinine > 2 mg/dL or creatinine clearance <=30mL/min) - severe liver diseases - atrial fibrillation or ventricular tachycardia - lung edema - hypertonic dehydration - known hypersensitivity to study medication - preoperative anemia with hemoglobin levels <= 10 mg/dL
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare two goal directed infusion therapies for patients undergoing open colorectal surgery with Volulyte (colloid treatment group) or Jonosteril (crystalloid control group). Comparison between the two groups will be based on the amount of fluids (mL) required to achieve hemodynamic stabilization.;Secondary Objective: - incidence of surgery related complications until 28 and 90 day after surgery - incidence of PONV - Time of first defacation and signs of first bowl movements - postoperative pain - stroke volume, stroke volume variability, cardiac output - postoperative weight gain - extracellular water and intracellular water - total volume of study medication - total volume of PRB - need for vasopressors - NT-proBNP and Arginin-Vasopressin plasma level - Lactate level - time patients ready for discharge (according to discharge criteria) - incidence of readmission within 28 and 90 days - safety;Primary end point(s): Total volume of administered fluids intraoperatively that is necessary to keep patients optimal hemodynamic stabilized;Timepoint(s) of evaluation of this end point: intraoperatively | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Incidence of surgery related complications - Incidence of nausea and vomiting - Gastrointestinal function - Postoperative pain - SVV, SV, CI - Postoperative weight gain - Total volume of study medication - ECW, ICW, TBW - Total volume of blood products - Administration of vasopressors - Postoperative changes in NT-proBNP and arginine vasopressin plasma levels - Hospitalization time - Incidence of readmissions - Safety;Timepoint(s) of evaluation of this end point: - 2, 6, 24, 48 and 72 h postoperatively (Pain and PONV) - daily until day 4 postoperatively (weight gain, ECW, ICW, TBW, gastrointestinal function, complications) - 28 and 90 days postoperatively (complication, readmission) - 30 min before anesthesia, 30 min after skin incision and immediately at the end of surgery (SV, SVV, CI) - 1 day postoperatively (plasma level) | — |
Countries
Germany
Contacts
Public ContactDept. of Anaesthesiology
University Hospital Muenster
Outcome results
None listed