Clinical trial NCT01117649: Plasma Volume Replacement (PVR) Therapy With Colloid and Crystalloid Solutions
Official title: Prospective, Controlled, Double-blind, Randomized Multi-centric Study on the Efficacy and Safety of a Target Controlled PVR Therapy With a Hyperoncotic Balanced Hydroxyethyl Starch (HES) Solution Versus an Isooncotic Balanced HES Solution Compared to a Balanced Electrolyte Solution in Elective Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Plasma Volume Replacement
Surgery of the Pancreatic Head
Keywords: PVR
HES 130
pancreatic head
goal-directed
intraoperative PVR in elective surgery of the pancreatic head
Lead sponsor: B. Braun Melsungen AG
Sponsor class: INDUSTRY
First posted: 2010-05-05
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: First endpoint: Intraoperatively required amount of HES (10%, 6%) (ml)
timeFrame: up to 8 hours
measure: Second endpoint: Time until fully on oral (solid) diet (days)
timeFrame: up to 15 days
Secondary outcomes:
measure: haemodynamics, arterial blood gas analysis, laboratory data, postoperative nausea and vomiting, adverse events, nursing delirium screening scale, several injury scores
timeFrame: up to 7 days
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Klinik für Anästhesie und operative Intensivmedizin, Charité-Universitätsmedizin Berlin
city: Berlin
country: Germany
facility: Klinik für Anästhesie, operative Intensivmedizin und Schmerztherapie, Humboldt Klinikum
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn
Study officials:
affiliation: Klinik für Anästhesie und operative Intensivmedizin, Charité-Universitätsmedizin Berlin, Campus Virchow-Klinikum
name: Claudia Spies, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: