acid-base status intraoperatively and postoperatively MedDRA version: 14.1 Level: PT Classification code 10000456 Term: Acid base balance System Organ Class: 10022891 - Investigations
Conditions
Interventions
Trade Name: Gelafundin ISO 40 mg/ml Infusionslösung
Product Name: Gelafundin ISO 40 mg/ml Infusionslösung
Product Code: Gelofusine Balanced
Pharmaceutical Form: Solution for infusion
CAS Number: 80000
Sponsors
B. Braun Melsungen AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male or female patients older than 18 years of age and younger than 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 bowel 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 42 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 22
Exclusion criteria
Exclusion criteria: ? 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 o Hypervolemia o Hyperhydration o Severe blood coagulation disorders o Hypernatremia (serum(Na+) > 150 mmol/L) o Hyperchloremia (serum(Cl-) > 110 mmol/L) o Hypercalcaemia (serum(Ca++ - total) > 3 mmol/L or serum (Ca++-free) > 1.5 mmol/L) o Metabolic alcalosis o Severe heart insufficiency o Severe generalized edema o Intracranial haemorrhage o Hyperkalaemia (serum(K+) > 5.5 mmol/L) ? Estimated perioperative need for blood products of more than 3.5 mL/kg body weight (Broca) ? Lactation period ? Simultaneous participation in another clinical trial ? Emergencies ? Patients suffering from o moderate heart or lung insufficiency o moderate lung edema o hypertonia o eclampsia who do not allow the IP regimen as required.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the change in acid-base balance from baseline to end of surgery;Secondary Objective: To investigate safety and efficacy parameters ;Primary end point(s): Difference in base excess and chloride (baseline - end of surgery) after treatment between the two volume replacement regimens;Timepoint(s) of evaluation of this end point: baseline – immediately after end of surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - arterial blood gase analyses, - coagulation status - renal function - requirement of blood products - adverse events - hemodynamics - investigational product administration according to the defined algorithm - clinical outcome - demographic data - surgery related data;Timepoint(s) of evaluation of this end point: baseline – 12 hours after end of surgery | — |
Countries
Germany
Contacts
Public ContactClinical Development
B. Braun Melsungen AG
Outcome results
None listed