Thermodilution - Controlled Management of Volume Therapy in Septic Shock

Septic Shock Clinical Trial

— THEMIS  

Official title:

A Randomized Mono-center Study Looking at the Effect of Thermodilution Controlled Therapy for Volume Optimization on the Duration of Septic Shock in Patients With Septic Shock

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01263977
• Other study ID #: THEMIS
• 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

• Septic Shock
• Shock
• Shock, Septic
• Volume Status

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