Thermodilution - Controlled Management of Volume Therapy in Septic Shock

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:

• 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 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