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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
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: 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
Pharmaceutical Solutions
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014