Comparison of Two Gelatine Solutions

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Hypovolemia

Intervention / Treatment
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* Drug: Gelofusine balanced
* Drug: Gelofusine 4%


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: balanced gelatine solution<br>isotonic colloidal volume substitute | Drug: Gelofusine balanced<br>* Gelofusine balanced combined with Sterofundin ISO<br>|
| Active Comparator: non-balanced gelatine solution<br>colloidal volume substitute | Drug: Gelofusine 4%<br>* Gelofusine 4% combined with NaCl 0.9%<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| base excess [mmol/l] |  | Change from baseline at end of surgery, an expected average of 2 hours surgery | 
| chloride [mmol/l] |  | Change from baseline at end of surgery, an expected average of 2 hours surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| arterial blood gase analyses |  | until 12 hours after surgery | 
| coagulation status |  | until 12 hours after surgery | 
| renal function |  | until 12 hours after surgery | 
| adverse events |  | until 12 hours after surgery | 
| hemodynamics (systolic and diastolic blood pressure) |  | until 12 hours after surgery | 
| time on ventilation |  | until 12 hours after surgery |