Thermodilution - Controlled Management of Volume Therapy in Septic Shock

NCT ID: NCT01263977

Last Updated: 2014-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2014-05-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Thermodilution controlled volume management

Volume management based on parameters: GEDI, ELWI, CI

Group Type: EXPERIMENTAL

Picco- thermodilution catheter

Intervention Type: DEVICE

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

Volume management based on surviving sepsis campaign

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

Group Type: ACTIVE_COMPARATOR

Picco- thermodilution catheter

Intervention Type: DEVICE

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

Interventions

Picco- thermodilution catheter

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

Intervention Type: DEVICE

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:

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Claudia Spies

OTHER

Sponsor Role: lead

Responsible Party

Claudia Spies

Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charite University, Berlin, Germany

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Claudia D Spies, MD, Prof.

Role: STUDY_DIRECTOR

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

Michael Sander, MD, Prof.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Berlin, State of Berlin, Germany

Countries

Germany

Other Identifiers

THEMIS

Identifier Type: -

Identifier Source: org_study_id