Comparison of Two Gelatine Solutions

B. Braun Melsungen AG40 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Hypovolemia

Interventions

Gelofusine balancedDRUG

Gelofusine balanced combined with Sterofundin ISO

Gelofusine 4%DRUG

Gelofusine 4% combined with NaCl 0.9%

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (2)

Universitätsklinikum Aachen, Klinik für Anästhesiologie

Aachen, Germany

Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie, Universitätsklinikum Frankfurt/Main

Frankfurt am Main, Germany

Outcomes

Primary Outcomes

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