Status:
COMPLETED
Comparison of Two Gelatine Solutions
Lead Sponsor:
B. Braun Melsungen AG
Conditions:
Hypovolemia
Eligibility:
All Genders
18-90 years
Phase:
PHASE3
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 achie...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01515397
Start Date
December 1 2011
End Date
January 1 2013
Last Update
November 27 2013
Active Locations (2)
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1
Universitätsklinikum Aachen, Klinik für Anästhesiologie
Aachen, Germany, 52074
2
Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie, Universitätsklinikum Frankfurt/Main
Frankfurt am Main, Germany, 60590