Clinical trial NCT01263977: Thermodilution - Controlled Management of Volume Therapy in Septic Shock
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
Overall status: COMPLETED
Phase: NA
Conditions: Septic Shock
Volume Status
Keywords: septic shock
goal directed volume therapy
outcome
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2010-12-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)


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

Primary outcomes:
measure: Duration of septic shock
timeFrame: 6 months
Secondary outcomes:
measure: 28 day mortality
timeFrame: max 28 Tage
measure: 90 and 180 days mortality
timeFrame: max 180 days
measure: Intensive care mortality
timeFrame: max 28 days
measure: Frequency of arterial hypoperfusion in the extremity of the thermodilution
timeFrame: max. 28 days
Other outcomes:
Locations:
city: Berlin,
country: Germany
facility: Department of Anesthesiology and Intensive Care Medicine Campus Charité Mitte and Campus Virchow-Klinikum, Charité - Universitaetsmedizin Berlin
state: Berlin
Study officials:
affiliation: Dept. of Anesthesiology and Intensive Care Medicine, CCM and CVK, Charité - Universitaetsmedizin Berlin
name: Claudia D Spies, MD, Prof.
role: STUDY_DIRECTOR
affiliation: Dept. of Anesthesiology and Intensive Care Medicine, CCM and CVK, Charité - Universitaetsmedizin Berlin
name: Michael Sander, MD, Prof.
role: PRINCIPAL_INVESTIGATOR
References: