Comparison of Two Gelatine Solutions
Primary Purpose
Hypovolemia
Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Gelofusine balanced
Gelofusine 4%
Sponsored by
About this trial
This is an interventional treatment trial for Hypovolemia
Eligibility 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
Sites / Locations
- Universitätsklinikum Aachen, Klinik für Anästhesiologie
- Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie, Universitätsklinikum Frankfurt/Main
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
balanced gelatine solution
non-balanced gelatine solution
Arm Description
isotonic colloidal volume substitute
colloidal volume substitute
Outcomes
Primary Outcome Measures
base excess [mmol/l]
chloride [mmol/l]
Secondary Outcome Measures
arterial blood gase analyses
coagulation status
renal function
adverse events
hemodynamics (systolic and diastolic blood pressure)
time on ventilation
Full Information
NCT ID
NCT01515397
First Posted
January 2, 2012
Last Updated
November 26, 2013
Sponsor
B. Braun Melsungen AG
1. Study Identification
Unique Protocol Identification Number
NCT01515397
Brief Title
Comparison of Two Gelatine Solutions
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 Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
B. Braun Melsungen AG
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypovolemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
balanced gelatine solution
Arm Type
Experimental
Arm Description
isotonic colloidal volume substitute
Arm Title
non-balanced gelatine solution
Arm Type
Active Comparator
Arm Description
colloidal volume substitute
Intervention Type
Drug
Intervention Name(s)
Gelofusine balanced
Intervention Description
Gelofusine balanced combined with Sterofundin ISO
Intervention Type
Drug
Intervention Name(s)
Gelofusine 4%
Intervention Description
Gelofusine 4% combined with NaCl 0.9%
Primary Outcome Measure Information:
Title
base excess [mmol/l]
Time Frame
Change from baseline at end of surgery, an expected average of 2 hours surgery
Title
chloride [mmol/l]
Time Frame
Change from baseline at end of surgery, an expected average of 2 hours surgery
Secondary Outcome Measure Information:
Title
arterial blood gase analyses
Time Frame
until 12 hours after surgery
Title
coagulation status
Time Frame
until 12 hours after surgery
Title
renal function
Time Frame
until 12 hours after surgery
Title
adverse events
Time Frame
until 12 hours after surgery
Title
hemodynamics (systolic and diastolic blood pressure)
Time Frame
until 12 hours after surgery
Title
time on ventilation
Time Frame
until 12 hours after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gernot Marx, Prof. Dr. med.
Organizational Affiliation
Universitätsklinikum Aachen,Klinik für Operative Intensivmedizin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitätsklinikum Aachen, Klinik für Anästhesiologie
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Facility Name
Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie, Universitätsklinikum Frankfurt/Main
City
Frankfurt/Main
ZIP/Postal Code
60590
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
31034525
Citation
Marx G, Meybohm P, Schuerholz T, Lotz G, Ledinko M, Schindler AW, Rossaint R, Zacharowski K. Impact of a new balanced gelatine on electrolytes and pH in the perioperative care. PLoS One. 2019 Apr 29;14(4):e0213057. doi: 10.1371/journal.pone.0213057. eCollection 2019.
Results Reference
derived
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Comparison of Two Gelatine Solutions
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