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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Claudia Spies, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01263977
First received: December 20, 2010
Last updated: June 5, 2014
Last verified: June 2014
  Purpose

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)


Condition Intervention
Septic Shock
Volume Status
Device: Picco- thermodilution catheter

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Duration of septic shock [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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


Secondary Outcome Measures:
  • 28 day mortality [ Time Frame: max 28 Tage ] [ Designated as safety issue: No ]
  • 90 and 180 days mortality [ Time Frame: max 180 days ] [ Designated as safety issue: No ]
  • Intensive care mortality [ Time Frame: max 28 days ] [ Designated as safety issue: No ]
  • Frequency of arterial hypoperfusion in the extremity of the thermodilution [ Time Frame: max. 28 days ] [ Designated as safety issue: Yes ]

Enrollment: 60
Study Start Date: December 2010
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Thermodilution controlled volume management
Volume management based on parameters: GEDI, ELWI, CI
Device: Picco- thermodilution catheter
Transpulmonary thermodilution and pulse contour analysis with arterial catheter Arterial access via femoral
Active Comparator: Volume management based on surviving sepsis campaign
volume management based on surviving sepsis campaign guidelines: CVP, Urin output, MAP, ScvO2
Device: Picco- thermodilution catheter
Transpulmonary thermodilution and pulse contour analysis with arterial catheter Arterial access via femoral

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01263977

Locations
Germany
Department of Anesthesiology and Intensive Care Medicine Campus Charité Mitte and Campus Virchow-Klinikum, Charité - Universitaetsmedizin Berlin
Berlin,, Berlin, Germany, 10117
Sponsors and Collaborators
Claudia Spies
Investigators
Study Director: Claudia D Spies, MD, Prof. Dept. of Anesthesiology and Intensive Care Medicine, CCM and CVK, Charité - Universitaetsmedizin Berlin
Principal Investigator: Michael Sander, MD, Prof. Dept. of Anesthesiology and Intensive Care Medicine, CCM and CVK, Charité - Universitaetsmedizin Berlin
  More Information

No publications provided

Responsible Party: Claudia Spies, Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charite University, Berlin, Germany, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01263977     History of Changes
Other Study ID Numbers: THEMIS
Study First Received: December 20, 2010
Last Updated: June 5, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by Charite University, Berlin, Germany:
septic shock
goal directed volume therapy
outcome

Additional relevant MeSH terms:
Shock
Shock, Septic
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation

ClinicalTrials.gov processed this record on July 23, 2014