Thermodilution - Controlled Management of Volume Therapy in Septic Shock (THEMIS)

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