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It is the objective of the study to investigate the efficacy and safety of two different volume replacement regimens with gelatine solutions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| balanced gelatine solution | Experimental | isotonic colloidal volume substitute |
|
| non-balanced gelatine solution | Active Comparator | colloidal volume substitute |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gelaspan 4% | Drug | Gelaspan 4% combined with Sterofundin ISO |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Base Excess | Change in base excess from baseline to end of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Base Excess | Change in base excess from baseline to 12 hours after end of surgery | |
| Adverse events | until 12 hours after end of surgery | |
| Hemodynamics |
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Inclusion:
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:
Pregnancy and/or nursing.
Hypertension with the Systolic Blood Pressure > 180 mm Hg and Diastolic Blood Pressure > 110 mm Hg identified at screening.
Patients who in the investigator's opinion couldn't take part in the study.
Simultaneous participation in another clinical trial.
Emergencies.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Road Clinical Hospital of JSC "Russian Railways | Saint Petersburg | 195271 | Russia | |||
| North-Western Federal Medical Research Center n.a. V.A. Almazov |
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| ID | Term |
|---|---|
| D020896 | Hypovolemia |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Gelofusine 4% |
| Drug |
Gelofusine 4% combined with Sodium Chloride |
|
| until 12 hours after end of surgery |
| Renal Function | until 12 hours after end of surgery |
| Arterial blood gas analysis | until 12 hours after end of surgery |
| Coagulation status | until 12 hours after end of surgery |
| Saint Petersburg |
| 197341 |
| Russia |
| City Clinical Oncology Dispensary | Saint Petersburg | 198255 | Russia |