Comparison of Two Gelatine Solutions

• Status: Completed
• Trial end date: 2013-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: B. Braun Melsungen AG
• Treatments: Pharmaceutical Solutions; Polygeline

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