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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01263977
Other study ID # THEMIS
Secondary ID
Status Completed
Phase N/A
First received December 20, 2010
Last updated June 5, 2014
Start date December 2010
Est. completion date May 2014

Study information

Verified date June 2014
Source Charite University, Berlin, Germany
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

Clinical Trial Summary

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)


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date May 2014
Est. primary completion date May 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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:

1. Proof of pathological microorganism in blood, sputum, urine or normally sterile body tissues

2. Identifiable focus (e.g. purulent sputum or wound secretion, perforated gut)

3. Identification of granulocytes in normally sterile tissue

4. Clinical suspicion of infection without identification of pathogens or micro-organisms (e.g. new pulmonary infiltrates on chest x-ray, treated pneumonia, purpura fulminants, necrotizing fasciitis)

- Confirmation of SIRS (= 48 hours possible), with at least 2 criteria from a-d required:

1. Fever (=38 °C) or Hypothermia (= 36 °C)

2. Tachycardia (= 90/min)

3. Tachypnoea (= 20/min) or Hyperventilation (PaCO2 = 32 mmHg, = 4,4 kPa) or mechanical ventilation

4. Leukocytes (= 12,000/µl) or Leucopenia (= 4,000/µl) or = 10% immature granulocytes

- 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:

- Therapy limited (DNR-Order)

- Patient moribund

- Pregnancy (positive pregnancy test in women of child bearing age)

- Breast feeding women

- Age < 18 years

- Patients active treatment for congestive heart failure with Ejection fraction < 30% and/or NYHA Class IV congestive heart failure

- Severe peripheral Arterial Vascular Occlusion Disease = 2b after Fontaine

- Patients with Glasgow Coma Score = 8 at the time of admission and prior to the administration of medications such as sedatives

- Patients with TNM stage 4 solid tumors, hematologic malignancies with high tumor burden, CNS tumors (WHO stage 4)

- Patients who are likely to die within days for diseases or conditions other than catecholamine-dependent shock

- Participation in another interventional clinical study within the last 30 days

- Particular relationship to senior investigator (e.g. staff, relative, colleague)

- Patients with severe liver dysfunction (Child C)

- Patients with septic shock within the last 60 days

- Patients receiving norepinephrine for longer than 48 hours

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
Picco- thermodilution catheter
Transpulmonary thermodilution and pulse contour analysis with arterial catheter Arterial access via femoral

Locations

Country Name City State
Germany Department of Anesthesiology and Intensive Care Medicine Campus Charité Mitte and Campus Virchow-Klinikum, Charité - Universitaetsmedizin Berlin Berlin, Berlin

Sponsors (1)

Lead Sponsor Collaborator
Claudia Spies

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Yes
Secondary 28 day mortality max 28 Tage No
Secondary 90 and 180 days mortality max 180 days No
Secondary Intensive care mortality max 28 days No
Secondary Frequency of arterial hypoperfusion in the extremity of the thermodilution max. 28 days Yes
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