We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparison of Two Gelatine 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.
ClinicalTrials.gov Identifier: NCT01515397
Recruitment Status : Completed
First Posted : January 24, 2012
Last Update Posted : November 27, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Hypovolemia Drug: Gelofusine balanced Drug: Gelofusine 4% Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : December 2011
Primary Completion Date : January 2013
Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Gelatin
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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%


Outcome Measures

Primary Outcome Measures :
  1. base excess [mmol/l] [ Time Frame: Change from baseline at end of surgery, an expected average of 2 hours surgery ]
  2. chloride [mmol/l] [ Time Frame: Change from baseline at end of surgery, an expected average of 2 hours surgery ]

Secondary Outcome Measures :
  1. arterial blood gase analyses [ Time Frame: until 12 hours after surgery ]
  2. coagulation status [ Time Frame: until 12 hours after surgery ]
  3. renal function [ Time Frame: until 12 hours after surgery ]
  4. adverse events [ Time Frame: until 12 hours after surgery ]
  5. hemodynamics (systolic and diastolic blood pressure) [ Time Frame: until 12 hours after surgery ]
  6. time on ventilation [ Time Frame: until 12 hours after surgery ]

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

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 ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: B. Braun Melsungen AG
ClinicalTrials.gov Identifier: NCT01515397     History of Changes
Other Study ID Numbers: HC-G-H-0904
First Posted: January 24, 2012    Key Record Dates
Last Update Posted: November 27, 2013
Last Verified: November 2013

Additional relevant MeSH terms:
Hypovolemia
Pathologic Processes
Pharmaceutical Solutions
Polygeline
Plasma Substitutes
Blood Substitutes