Comparison of Two Gelatine Solutions

NCT ID: NCT01515397

Last Updated: 2013-11-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2013-01-31

Brief 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.

Conditions

Hypovolemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

balanced gelatine solution

isotonic colloidal volume substitute

Group Type: EXPERIMENTAL

Gelofusine balanced

Intervention Type: DRUG

Gelofusine balanced combined with Sterofundin ISO

non-balanced gelatine solution

colloidal volume substitute

Group Type: ACTIVE_COMPARATOR

Gelofusine 4%

Intervention Type: DRUG

Gelofusine 4% combined with NaCl 0.9%

Interventions

Gelofusine balanced

Gelofusine balanced combined with Sterofundin ISO

Intervention Type: DRUG

Gelofusine 4%

Gelofusine 4% combined with NaCl 0.9%

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

B. Braun Melsungen AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gernot Marx, Prof. Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Aachen,Klinik für Operative Intensivmedizin

Locations

Universitätsklinikum Aachen, Klinik für Anästhesiologie

Aachen, , Germany

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

Frankfurt am Main, , Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 31034525 (View on PubMed)

Other Identifiers

HC-G-H-0904

Identifier Type: -

Identifier Source: org_study_id