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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