Comparison of Two Gelatine Solutions
Overview
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.
Full Title of Study: “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
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Study Primary Completion Date: January 2013
Interventions
- Drug: Gelofusine balanced
- Gelofusine balanced combined with Sterofundin ISO
- Drug: Gelofusine 4%
- Gelofusine 4% combined with NaCl 0.9%
Arms, Groups and Cohorts
- Experimental: balanced gelatine solution
- isotonic colloidal volume substitute
- Active Comparator: non-balanced gelatine solution
- colloidal volume substitute
Clinical Trial Outcome Measures
Primary Measures
- base excess [mmol/l]
- Time Frame: Change from baseline at end of surgery, an expected average of 2 hours surgery
- chloride [mmol/l]
- Time Frame: Change from baseline at end of surgery, an expected average of 2 hours surgery
Secondary Measures
- arterial blood gase analyses
- Time Frame: until 12 hours after surgery
- coagulation status
- Time Frame: until 12 hours after surgery
- renal function
- Time Frame: until 12 hours after surgery
- adverse events
- Time Frame: until 12 hours after surgery
- hemodynamics (systolic and diastolic blood pressure)
- Time Frame: until 12 hours after surgery
- time on ventilation
- Time Frame: until 12 hours after surgery
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 90 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- B. Braun Melsungen AG
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Gernot Marx, Prof. Dr. med., Principal Investigator, Universitätsklinikum Aachen,Klinik für Operative Intensivmedizin
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