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

Primary Purpose

Septic Shock, Volume Status

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Picco- thermodilution catheter

About this trial

This is an interventional treatment trial for Septic Shock focused on measuring septic shock, goal directed volume therapy, outcome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Thermodilution controlled volume management

Volume management based on surviving sepsis campaign

Arm Description

Volume management based on parameters: GEDI, ELWI, CI

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

28 day mortality

90 and 180 days mortality

Intensive care mortality

Frequency of arterial hypoperfusion in the extremity of the thermodilution

Full Information

NCT ID

NCT01263977

First Posted

December 20, 2010

Last Updated

June 5, 2014

Sponsor

Claudia Spies

1. Study Identification

Unique Protocol Identification Number

NCT01263977

Brief Title

Thermodilution - Controlled Management of Volume Therapy in Septic Shock

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2014

Overall Recruitment Status

Completed

Study Start Date

December 2010 (undefined)

Primary Completion Date

May 2014 (Actual)

Study Completion Date

May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Claudia Spies

4. Oversight

Data Monitoring Committee

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Septic Shock, Volume Status

Keywords

septic shock, goal directed volume therapy, outcome

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Thermodilution controlled volume management

Arm Type

Experimental

Arm Description

Volume management based on parameters: GEDI, ELWI, CI

Arm Title

Volume management based on surviving sepsis campaign

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Picco- thermodilution catheter

Intervention Description

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

Primary Outcome Measure Information:

Title

Duration of septic shock

Description

Time Frame

6 months

Secondary Outcome Measure Information:

Title

28 day mortality

Time Frame

max 28 Tage

Title

90 and 180 days mortality

Time Frame

max 180 days

Title

Intensive care mortality

Time Frame

max 28 days

Title

Frequency of arterial hypoperfusion in the extremity of the thermodilution

Time Frame

max. 28 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Claudia D Spies, MD, Prof.

Organizational Affiliation

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

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Michael Sander, MD, Prof.

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Berlin,

State/Province

Berlin

ZIP/Postal Code

10117

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

Thermodilution - Controlled Management of Volume Therapy in Septic Shock

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