Comparison of Two Gelatine Solutions

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

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 Overview

• Status: Completed
• Conditions: Hypovolemia
• Intervention / Treatment: Drug: Gelofusine balanced; Drug: Gelofusine 4%

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 3

Contacts and Locations

Study Locations

• Germany
  • Aachen, Germany, 52074
    • Universitätsklinikum Aachen, Klinik für Anästhesiologie
  • Frankfurt/Main, Germany, 60590
    • Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie, Universitätsklinikum Frankfurt/Main

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: balanced gelatine solution; isotonic colloidal volume substitute	Drug: Gelofusine balanced; Gelofusine balanced combined with Sterofundin ISO
ACTIVE_COMPARATOR: non-balanced gelatine solution; colloidal volume substitute	Drug: Gelofusine 4%; Gelofusine 4% combined with NaCl 0.9%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: B. Braun Melsungen AG
• Investigators: Principal Investigator: Gernot Marx, Prof. Dr. med., Universitätsklinikum Aachen,Klinik für Operative Intensivmedizin

Publications and helpful links

General Publications

• Marx G, Meybohm P, Schuerholz T, Lotz G, Ledinko M, Schindler AW, Rossaint R, Zacharowski K. Impact of a new balanced gelatine on electrolytes and pH in the perioperative care. PLoS One. 2019 Apr 29;14(4):e0213057. doi: 10.1371/journal.pone.0213057. eCollection 2019.

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (ACTUAL): January 1, 2013
• Study Completion (ACTUAL): January 1, 2013

Study Registration Dates

• First Submitted: January 2, 2012
• First Submitted That Met QC Criteria: January 18, 2012
• First Posted (ESTIMATE): January 24, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): November 27, 2013
• Last Update Submitted That Met QC Criteria: November 26, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hypovolemia; Plasma Substitutes; Blood Substitutes; Polygeline
• Other Study ID Numbers: HC-G-H-0904