Comparison of Two Gelatine Solutions

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
B. Braun Melsungen AG
ClinicalTrials.gov Identifier:
NCT01515397
First received: January 2, 2012
Last updated: November 26, 2013
Last verified: November 2013
  Purpose

The aim of volume replacement is to compensate a reduction in the intravascular volume e.g. during surgery and to counteract hypovolemia in order to maintain hemodynamics and vital functions. To achieve this, different plasma substitutes are available: Albumin, dextran, hydroxyethylstarches and gelatine. The aim of this study is to demonstrate that acid-base alterations during elective abdominal surgery can be reduced by the use of a new gelatine solution.


Condition Intervention Phase
Hypovolemia
Drug: Gelofusine balanced
Drug: Gelofusine 4%
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of a Balanced Gelatine Solution in Combination With a Balanced Electrolyte Solution Versus a Standard Gelatine Solution in Combination With a Non-balanced Electrolyte Solution in Patients Scheduled for Abdominal Surgery

Resource links provided by NLM:


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

Primary Outcome Measures:
  • base excess [mmol/l] [ Time Frame: Change from baseline at end of surgery, an expected average of 2 hours surgery ] [ Designated as safety issue: No ]
  • chloride [mmol/l] [ Time Frame: Change from baseline at end of surgery, an expected average of 2 hours surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • arterial blood gase analyses [ Time Frame: until 12 hours after surgery ] [ Designated as safety issue: Yes ]
  • coagulation status [ Time Frame: until 12 hours after surgery ] [ Designated as safety issue: Yes ]
  • renal function [ Time Frame: until 12 hours after surgery ] [ Designated as safety issue: Yes ]
  • adverse events [ Time Frame: until 12 hours after surgery ] [ Designated as safety issue: Yes ]
  • hemodynamics (systolic and diastolic blood pressure) [ Time Frame: until 12 hours after surgery ] [ Designated as safety issue: No ]
  • time on ventilation [ Time Frame: until 12 hours after surgery ] [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: December 2011
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: balanced gelatine solution
isotonic colloidal volume substitute
Drug: Gelofusine balanced
Gelofusine balanced combined with Sterofundin ISO
Active Comparator: non-balanced gelatine solution
colloidal volume substitute
Drug: Gelofusine 4%
Gelofusine 4% combined with NaCl 0.9%

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion:

  • Male or female patients >= 18 years of age and <= 90 years of age. Women of child bearing potential must test negative on standard pregnancy test.
  • Patients scheduled to undergo elective abdominal surgery (e.g. Rectal resection, liver resection, open bowl resection, duodenopancreatectomy reconstitution).
  • Scheduled intraoperative volume requirement of at least 15 ml / kg body weight (BROCA) gelatine solution
  • Provision 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 ASA-class > III
  • Known hypersensitivity to gelatine or to any of the constituents of the solution
  • Patients treated with other colloid solutions and / or blood products 24 hours prior to surgery
  • Patients on hemodialysis
  • Patients suffering from decompensated renal function (i.e. serum creatinine > 3.0 mg/dl)
  • Patients suffering from Hypervolemia Hyperhydration Severe blood coagulation disorders Hypernatremia (serum(Na+) > 150 mmol/L) Hyperchloremia (serum(Cl-) > 110 mmol/L)
  • Estimated perioperative need for blood products of 3,5 ml / kg body weight (BROCA)
  • Lactation period
  • Simultaneous participation in another clinical trial
  • Emergencies
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01515397

Locations
Germany
Universitätsklinikum Aachen, Klinik für Anästhesiologie
Aachen, Germany, 52074
Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie, Universitätsklinikum Frankfurt/Main
Frankfurt/Main, Germany, 60590
Sponsors and Collaborators
B. Braun Melsungen AG
Investigators
Principal Investigator: Gernot Marx, Prof. Dr. med. Universitätsklinikum Aachen,Klinik für Operative Intensivmedizin
  More Information

No publications provided

Responsible Party: B. Braun Melsungen AG
ClinicalTrials.gov Identifier: NCT01515397     History of Changes
Other Study ID Numbers: HC-G-H-0904
Study First Received: January 2, 2012
Last Updated: November 26, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Hypovolemia
Pathologic Processes
Polygeline
Plasma Substitutes
Blood Substitutes
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014