Comparison of Two Gelatine Solutions

Hypovolemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01515397
• Other study ID #: HC-G-H-0904
• Status: Completed
• Phase: Phase 3
• First received: January 2, 2012
• Last updated: November 26, 2013
• Start date: December 2011
• Est. completion date: January 2013

Study information

• Verified date: November 2013
• Source: B. Braun Melsungen AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypovolemia

Intervention

Drug:
• Gelofusine balanced
Gelofusine balanced combined with Sterofundin ISO
• Gelofusine 4%
Gelofusine 4% combined with NaCl 0.9%

Locations

Country	Name	City	State
Germany	Universitätsklinikum Aachen, Klinik für Anästhesiologie	Aachen
Germany	Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie, Universitätsklinikum Frankfurt/Main	Frankfurt/Main

Sponsors (1)

Lead Sponsor	Collaborator
B. Braun Melsungen AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	base excess [mmol/l]		Change from baseline at end of surgery, an expected average of 2 hours surgery	No
Primary	chloride [mmol/l]		Change from baseline at end of surgery, an expected average of 2 hours surgery	No
Secondary	arterial blood gase analyses		until 12 hours after surgery	Yes
Secondary	coagulation status		until 12 hours after surgery	Yes
Secondary	renal function		until 12 hours after surgery	Yes
Secondary	adverse events		until 12 hours after surgery	Yes
Secondary	hemodynamics (systolic and diastolic blood pressure)		until 12 hours after surgery	No
Secondary	time on ventilation		until 12 hours after surgery	Yes