Thermodilution - Controlled Management of Volume Therapy in Septic Shock

NCT01263977 | Completed

• 1 other identifier: THEMIS
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Septic Shock; Volume Status

Keywords

septic shock; goal directed volume therapy; outcome

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• 28 day mortality

  max 28 Tage

• 90 and 180 days mortality

  max 180 days

• Intensive care mortality

  max 28 days

• Frequency of arterial hypoperfusion in the extremity of the thermodilution

  max. 28 days

Study Arms (2)

Thermodilution controlled volume management

EXPERIMENTAL

Volume management based on parameters: GEDI, ELWI, CI

Device: Picco- thermodilution catheter

Volume management based on surviving sepsis campaign

ACTIVE COMPARATOR

volume management based on surviving sepsis campaign guidelines: CVP, Urin output, MAP, ScvO2

Device: Picco- thermodilution catheter

Interventions

Picco- thermodilution catheter DEVICE

Transpulmonary thermodilution and pulse contour analysis with arterial catheter Arterial access via femoral

Thermodilution controlled volume management; Volume management based on surviving sepsis campaign

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Claudia Spies: lead

Study Sites (1)

Department of Anesthesiology and Intensive Care Medicine Campus Charité Mitte and Campus Virchow-Klinikum, Charité - Universitaetsmedizin Berlin

Berlin, State of Berlin, 10117, Germany

Location

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Claudia D Spies, MD, Prof.

  Dept. of Anesthesiology and Intensive Care Medicine, CCM and CVK, Charité - Universitaetsmedizin Berlin

  STUDY DIRECTOR

• Michael Sander, MD, Prof.

  Dept. of Anesthesiology and Intensive Care Medicine, CCM and CVK, Charité - Universitaetsmedizin Berlin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charite University, Berlin, Germany

Study Record Dates

• First Submitted: December 20, 2010
• First Posted: December 21, 2010
• Study Start: December 1, 2010
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: June 6, 2014

Record last verified: 2014-06

Locations

DE (1)