Intraoperative plasma volume replacement requirement in elective surgery of the pancreatic head (pylorus preserving pancreatic-duodenectomy, PPPD) MedDRA version: 14.0 Level: LLT Classification code 10059909 Term: Volume plasma System Organ Class: 10022891 - Investigations
Conditions
Interventions
Trade Name: Tetraspan 10%
Product Name: HES 130/042
Pharmaceutical Form: Solution for infusion
Current Sponsor code: HES 130/042
Other descriptive name: Poly(O-2-hydroxyethyl)starch
Concentration unit
Sponsors
B. Braun Melsungen AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male or female patients older than18 years of age and less than 80 years of age. Women of child bearing potential must test negative on standard pregnancy test (urine). - Patients scheduled to undergo elective surgery of the pancreatic head (e.g. PPPD) - Patients who are willing to give of voluntary consent to participate in the study, following a full explanation of the nature and purpose of the study, by signing the informed consent form approved by the Institutional Ethics Committee (IEC) prior to all evaluations. 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 200 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 28
Exclusion criteria
Exclusion criteria: - Patients of ASA-class > III - Heart failure defined as NYHA class>2 - Aneurysm of the ascending and thoracic aorta - Patients with Zenker’s diverticle - Local oesophageal disease (oesophageal stricture, oesophageal varices, previous oesophageal surgery in past 6 months before study inclusion, pharyngeal pouch) - Patients receiving haemodialysis - Patients with known bleeding diatheses - Any bleeding disorder known from patient’s history - Patients with a haematocrit ? 25% despite pre-op transfusion - Renal insufficiency (serum creatinine > 130 µmol/l or >1.5 mg/dl) or oliguria or anuria - Impaired hepatic function defined as MELD > 10 or liver cirrhosis Child-Pugh B or C - Additional contra-indications for either Tetraspan 6%, Tetraspan 10% and Sterofundin Iso - Pregnancy or lactation period - Simultaneous participation in another interventional clinical trial (AMG or MPG studies) - Emergencies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: It is the primary aim of the planned study to investigate on the efficacy of target controlled fluid therapy with a hyper-oncotic compared to an iso-oncotic balanced HES 130/0.42 solution in adult patients undergoing elective pancreatic surgery. ;Secondary Objective: Investigation of safety and secondary efficacy parameters of the balanced HES 130/0.42 solutions and of the balanced electrolyte solution.;Primary end point(s): A multiple primary endpoint is defined which is “the intra-operative amount (in mLs) of colloidal volume replacement therapy during target directed volume replacement therapy” as the first primary endpoint and “days until fully on oral (solid) diet” as the second primary endpoint (full on oral diet is defined by the absence of parenteral nutrition).;Timepoint(s) of evaluation of this end point: The study ends on postoperative Day 15 or discharge from hospital whatever occurs first. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary objectives are the investigation of safety and efficacy parameters like blood coagulation, perioperative blood loss, anastomotic or bowel leakage, renal function, haemodynamics, postoperative inflammation, intraabdominal pressure, adverse events and amount of given blood products (RBC, FFP, PC). Furthermore, descriptive comparison of the hyper- and iso-oncotic volume replacement therapy with HES to volume replacement therapy with a crystalloid alone will be made.;Timepoint(s) of evaluation of this end point: The study ends on postoperative Day 15 or discharge from hospital whatever occurs first. | — |
Countries
Germany
Contacts
Public ContactMedical Scientific Affairs
B. Braun Melsungen AG
Outcome results
None listed