Plasma Volume Replacement (PVR) Therapy With Colloid and Crystalloid Solutions

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

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.

Study Overview

• Status: Completed
• Conditions: Plasma Volume Replacement; Surgery of the Pancreatic Head
• Intervention / Treatment: Drug: HES 10%; Drug: HES 6%; Drug: balanced electrolyte solution

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Phase 4

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 13353
    • Klinik für Anästhesie und operative Intensivmedizin, Charité-Universitätsmedizin Berlin
  • Berlin, Germany, 13509
    • Klinik für Anästhesie, operative Intensivmedizin und Schmerztherapie, Humboldt Klinikum
  • Bonn, Germany, 53127
    • Universitatsklinikum Bonn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; hyper-oncotic colloid	Drug: HES 10%; HES 10% dissolved in plasma adapted Ringer's solution (balanced solution).
Active Comparator: 2; iso-oncotic colloid	Drug: HES 6%; HES 6% dissolved in plasma adapted Ringer's solution (balanced solution)
Active Comparator: 3; crystalloid	Drug: balanced electrolyte solution; plasma adapted Ringer's solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
First endpoint: Intraoperatively required amount of HES (10%, 6%) (ml)	Goal-directed (stroke volume) plasma volume therapy	up to 8 hours
Second endpoint: Time until fully on oral (solid) diet (days)		up to 15 days

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: B. Braun Melsungen AG
• Investigators: Principal Investigator: Claudia Spies, Prof. Dr., Klinik für Anästhesie und operative Intensivmedizin, Charité-Universitätsmedizin Berlin, Campus Virchow-Klinikum

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: April 28, 2010
• First Submitted That Met QC Criteria: May 4, 2010
• First Posted (Estimate): May 5, 2010

Study Record Updates

• Last Update Posted (Estimate): December 23, 2016
• Last Update Submitted That Met QC Criteria: December 22, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: PVR; HES 130; pancreatic head; goal-directed; intraoperative PVR in elective surgery of the pancreatic head
• Other Study ID Numbers: HC-G-H-0803