Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
|---|---|---|---|---|
| Gelofusine balanced | Drug | Gelofusine balanced combined with Sterofundin ISO |
| |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| arterial blood gase analyses | until 12 hours after surgery | |
| coagulation status | until 12 hours after surgery | |
| renal function |
Not provided
Inclusion:
Exclusion:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Gernot Marx, Prof. Dr. med. | Universitätsklinikum Aachen,Klinik für Operative Intensivmedizin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Aachen, Klinik für Anästhesiologie | Aachen | 52074 | Germany | |||
| Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie, Universitätsklinikum Frankfurt/Main |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31034525 | Derived | Marx G, Meybohm P, Schuerholz T, Lotz G, Ledinko M, Schindler AW, Rossaint R, Zacharowski K. Impact of a new balanced gelatine on electrolytes and pH in the perioperative care. PLoS One. 2019 Apr 29;14(4):e0213057. doi: 10.1371/journal.pone.0213057. eCollection 2019. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020896 | Hypovolemia |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Gelofusine 4% |
| Drug |
Gelofusine 4% combined with NaCl 0.9% |
|
| until 12 hours after surgery |
| adverse events | until 12 hours after surgery |
| hemodynamics (systolic and diastolic blood pressure) | until 12 hours after surgery |
| time on ventilation | until 12 hours after surgery |
| Frankfurt am Main |
| 60590 |
| Germany |