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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01117649
Recruitment Status : Completed
First Posted : May 5, 2010
Last Update Posted : December 23, 2016
Information provided by (Responsible Party):
B. Braun Melsungen AG

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.

Condition or disease Intervention/treatment Phase
Plasma Volume Replacement Surgery of the Pancreatic Head Drug: HES 10% Drug: HES 6% Drug: balanced electrolyte solution Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : May 2010
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2013

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
Drug: balanced electrolyte solution
plasma adapted Ringer's solution

Primary Outcome Measures :
  1. First endpoint: Intraoperatively required amount of HES (10%, 6%) (ml) [ Time Frame: up to 8 hours ]
    Goal-directed (stroke volume) plasma volume therapy

  2. Second endpoint: Time until fully on oral (solid) diet (days) [ Time Frame: up to 15 days ]

Secondary Outcome Measures :
  1. haemodynamics, arterial blood gas analysis, laboratory data, postoperative nausea and vomiting, adverse events, nursing delirium screening scale, several injury scores [ Time Frame: up to 7 days ]

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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.


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01117649

Klinik für Anästhesie und operative Intensivmedizin, Charité-Universitätsmedizin Berlin
Berlin, Germany, 13353
Klinik für Anästhesie, operative Intensivmedizin und Schmerztherapie, Humboldt Klinikum
Berlin, Germany, 13509
Universitätsklinikum Bonn
Bonn, Germany, 53127
Sponsors and Collaborators
B. Braun Melsungen AG
Principal Investigator: Claudia Spies, Prof. Dr. Klinik für Anästhesie und operative Intensivmedizin, Charité-Universitätsmedizin Berlin, Campus Virchow-Klinikum

Responsible Party: B. Braun Melsungen AG Identifier: NCT01117649     History of Changes
Other Study ID Numbers: HC-G-H-0803
First Posted: May 5, 2010    Key Record Dates
Last Update Posted: December 23, 2016
Last Verified: December 2016

Keywords provided by B. Braun Melsungen AG:
HES 130
pancreatic head
intraoperative PVR in elective surgery of the pancreatic head

Additional relevant MeSH terms:
Pharmaceutical Solutions