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Septic shock and multi-organ failure are among the most frequent causes of death in the ICU.
Patients with septic shock require early implementation of hemodynamic therapy to keep the duration of shock state and with it microcirculatory disturbances as short as possible. In the septic shock guidelines by the american association SCCM the diagnosis of volume status is based on filling pressures, like CVP. Some studies show, that the CVP depends not only on the intravascular volume, but also on the right ventricular compliance, pulmonary vascular resistance as well as intrathoracic pressure. The aim of the Study is to evaluate if the duration of septic shock can be reduced through algorithm driven volume therapy orientated to thermodilution based volume parameters (GEDI and ELWI)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thermodilution controlled volume management | Experimental | Volume management based on parameters: GEDI, ELWI, CI |
|
| Volume management based on surviving sepsis campaign | Active Comparator | volume management based on surviving sepsis campaign guidelines: CVP, Urin output, MAP, ScvO2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Picco- thermodilution catheter | Device | Transpulmonary thermodilution and pulse contour analysis with arterial catheter Arterial access via femoral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Duration of septic shock | septic shock is defined as sepsis with mean arterial pressure (MAP) <65mmHg or systolic arterial pressure (SAP) <90mmHg or the need for vasopressors to support the MAP >/= 65 mmHg or the SAP >/= 90 mmHg | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 28 day mortality | max 28 Tage | |
| 90 and 180 days mortality | max 180 days | |
| Intensive care mortality |
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Inclusion Criteria:
Informed consent from patient, authorized proxy, carer
In women of child bearing age, effective contraceptive use with a known failure rate of <1 %
Clinical verification of infection (≥ 48 hours possible), with at least one criteria from a - d required:
Confirmation of SIRS (≥ 48 hours possible), with at least 2 criteria from a-d required:
Sepsis-induced HYPOTENSION despite adequate volume status (<24h):
Mean arterial pressure (MAP) < 65 mmHg (< 8,7 kPa) or systolic arterial pressure (SAP) < 90 mmHg (< 12 kPa) or the need for vasopressor (Norepinephrine <0.05µg/kg/min) to support the MAP ≥ 65 mmHg (≥ 8,7 kPa) or the SAP ≥ 90 mmHg ≥ 12 kPa), when one of these criteria has lasted for 4 hours or longer.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Claudia D Spies, MD, Prof. | Dept. of Anesthesiology and Intensive Care Medicine, CCM and CVK, Charité - Universitaetsmedizin Berlin | Study Director |
| Michael Sander, MD, Prof. | Dept. of Anesthesiology and Intensive Care Medicine, CCM and CVK, Charité - Universitaetsmedizin Berlin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesiology and Intensive Care Medicine Campus Charité Mitte and Campus Virchow-Klinikum, Charité - Universitaetsmedizin Berlin | Berlin | State of Berlin | 10117 | Germany |
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| ID | Term |
|---|---|
| D012772 | Shock, Septic |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
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| max 28 days |
| Frequency of arterial hypoperfusion in the extremity of the thermodilution | max. 28 days |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |