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

Claudia Spies

Status

Completed

Conditions

Volume Status

Septic Shock

Treatments

Device: Picco- thermodilution catheter

Study type

Interventional

Funder types

Other

Identifiers

NCT01263977

THEMIS

Details and patient eligibility

About

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)

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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