Comparison of Two Gelatine Solutions
This study is currently recruiting participants.
Verified June 2012 by B. Braun Melsungen AG
Sponsor:
B. Braun Melsungen AG
Information provided by (Responsible Party):
B. Braun Melsungen AG
ClinicalTrials.gov Identifier:
NCT01515397
First received: January 2, 2012
Last updated: June 19, 2012
Last verified: June 2012
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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 ]
| Estimated Enrollment: | 64 |
| Study Start Date: | December 2011 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (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
Contacts
| Contact: study manager | +49-5661-71-0 | studies@bbraun.com |
Locations
| Germany | |
| Universitätsklinikum Aachen, Klinik für Anästhesiologie | Recruiting |
| Aachen, Germany, 52074 | |
| Contact: Gernot Marx, Prof. Dr. med. | |
| Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie, Universitätsklinikum Frankfurt/Main | Recruiting |
| Frankfurt/Main, Germany, 60590 | |
| Contact: Kai Zacharowski, Prof. Dr. Dr. med. | |
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: | June 19, 2012 |
| 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 June 18, 2013