Plasma Volume Replacement, Surgery of the Pancreatic Head
Conditions
Keywords
PVR, HES 130, pancreatic head, goal-directed, intraoperative PVR in elective surgery of the pancreatic head
Brief summary
The purpose of this study is to investigate the efficacy of target controlled fluid therapy with a hyper-oncotic balanced HES solution compared to an iso-oncotic HES solution in patients undergoing elective surgery of the pancreatic head. A third group receiving a balanced electrolyte solution (without colloidal volume replacement) will serve as a control for descriptive analysis.
Interventions
DRUGHES 10%
HES 10% dissolved in plasma adapted Ringer's solution (balanced solution).
DRUGHES 6%
HES 6% dissolved in plasma adapted Ringer's solution (balanced solution)
plasma adapted Ringer's solution
Sponsors
B. Braun Melsungen AG
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 80 Years
Healthy volunteers
No
Inclusion criteria
Inclusion: * patients scheduled to undergo elective surgery of the pancreatic head * 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. Exclusion: * patients of American Society of Anesthesiologists (ASA) class \> III * heart failure defined as New York Heart Association (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-operative transfusion * renal insufficiency (serum creatinine \> 130 µmol/l or \>1.5 mg/dl) or oliguria or anuria * impaired hepatic function defined as Mayo End-Stage Liver Disease (MELD) \> 10 or liver cirrhosis Child-Pugh B or C * additional contra-indications for investigational products
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| First endpoint: Intraoperatively required amount of HES (10%, 6%) (ml) | up to 8 hours | Goal-directed (stroke volume) plasma volume therapy |
| Second endpoint: Time until fully on oral (solid) diet (days) | up to 15 days | — |
Secondary
| Measure | Time frame |
|---|---|
| haemodynamics, arterial blood gas analysis, laboratory data, postoperative nausea and vomiting, adverse events, nursing delirium screening scale, several injury scores | up to 7 days |
Countries
Germany
Outcome results
None listed