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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
B. Braun Melsungen AG
ClinicalTrials.gov Identifier:
NCT01117649
First received: April 28, 2010
Last updated: September 6, 2013
Last verified: September 2013
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by B. Braun Melsungen AG:

Primary Outcome Measures:
  • First endpoint: Intraoperatively required amount of HES (10%, 6%) (ml) [ Time Frame: up to 8 hours ] [ Designated as safety issue: No ]
    Goal-directed (stroke volume) plasma volume therapy

  • Second endpoint: Time until fully on oral (solid) diet (days) [ Time Frame: up to 15 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 61
Study Start Date: May 2010
Study Completion Date: July 2013
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01117649

Locations
Germany
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
Investigators
Principal Investigator: Claudia Spies, Prof. Dr. Klinik für Anästhesie und operative Intensivmedizin, Charité-Universitätsmedizin Berlin, Campus Virchow-Klinikum
  More Information

No publications provided

Responsible Party: B. Braun Melsungen AG
ClinicalTrials.gov Identifier: NCT01117649     History of Changes
Other Study ID Numbers: HC-G-H-0803
Study First Received: April 28, 2010
Last Updated: September 6, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

Additional relevant MeSH terms:
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014