Status:
COMPLETED
Thermodilution - Controlled Management of Volume Therapy in Septic Shock
Lead Sponsor:
Claudia Spies
Conditions:
Septic Shock
Volume Status
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 sho...
Eligibility Criteria
Inclusion
- 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:
- Proof of pathological microorganism in blood, sputum, urine or normally sterile body tissues
- Identifiable focus (e.g. purulent sputum or wound secretion, perforated gut)
- Identification of granulocytes in normally sterile tissue
- 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:
- Fever (≥38 °C) or Hypothermia (≤ 36 °C)
- Tachycardia (≥ 90/min)
- Tachypnoea (≥ 20/min) or Hyperventilation (PaCO2 ≤ 32 mmHg, ≤ 4,4 kPa) or mechanical ventilation
- 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
- 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
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01263977
Start Date
December 1 2010
End Date
May 1 2014
Last Update
June 6 2014
Active Locations (1)
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1
Department of Anesthesiology and Intensive Care Medicine Campus Charité Mitte and Campus Virchow-Klinikum, Charité - Universitaetsmedizin Berlin
Berlin, State of Berlin, Germany, 10117