search
Back to results

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
B. Braun Melsungen AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypovolemia

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
January 2, 2012
Last Updated
November 26, 2013
Sponsor
B. Braun Melsungen AG
search

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

Learn more about this trial

Comparison of Two Gelatine Solutions

We'll reach out to this number within 24 hrs