Hypovolemia
Conditions
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.
Interventions
DRUGGelofusine balanced
Gelofusine balanced combined with Sterofundin ISO
DRUGGelofusine 4%
Gelofusine 4% combined with NaCl 0.9%
Sponsors
B. Braun Melsungen AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| 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
| Measure | Time frame |
|---|---|
| adverse events | until 12 hours after surgery |
| arterial blood gase analyses | until 12 hours after surgery |
| coagulation status | until 12 hours after surgery |
| time on ventilation | until 12 hours after surgery |
| hemodynamics (systolic and diastolic blood pressure) | until 12 hours after surgery |
| renal function | until 12 hours after surgery |
Countries
Germany
Outcome results
None listed