Septic ShockTHEMISNCT01263977
Thermodilution - Controlled Management of Volume Therapy in Septic Shock
A study testing Picco- thermodilution catheter in people with Septic Shock and Volume Status, run by Claudia Spies at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock, Volume Status
- What is being tested?
- Picco- thermodilution catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2010to May 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anesthesiology and Intensive Care Medicine Campus Charité Mitte and Campus Virchow-Klinikum, Charité - Universitaetsmedizin Berlin
Berlin, State of Berlin, 10117
About this study
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
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
- Being tested
- Picco- thermodilution catheter
- Keywords
- septic shock, goal directed volume therapy, outcome
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Picco- thermodilution catheterDevice
Transpulmonary thermodilution and pulse contour analysis with arterial catheter Arterial access via femoral
| Study group | Role | What they receive |
|---|---|---|
| Thermodilution controlled volume management | Experimental | Volume management based on parameters: GEDI, ELWI, CI Receives: 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 Receives: Device: Picco- thermodilution catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (4)
28 day mortality
Measured: max 28 Tage
90 and 180 days mortality
Measured: max 180 days
Intensive care mortality
Measured: max 28 days
Frequency of arterial hypoperfusion in the extremity of the thermodilution
Measured: max. 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Claudia Spies
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Claudia Spies, Charite University, Berlin, Germany
- Investigators
- Claudia D Spies, MD, Prof., Study director, Dept. of Anesthesiology and Intensive Care Medicine, CCM and CVK, Charité - Universitaetsmedizin BerlinMichael Sander, MD, Prof., Principal investigator, Dept. of Anesthesiology and Intensive Care Medicine, CCM and CVK, Charité - Universitaetsmedizin Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01263977
- Sponsor's protocol ID
- THEMIS
- Acronym
- THEMIS
- Status last verified
- Jun 2014
- First submitted
- 20 Dec 2010
- Last updated
- 6 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01263977
- Acronym / sponsor ID
- THEMIS / THEMIS
- Conditions
- Septic Shock, Volume Status
- Keywords
- septic shock, goal directed volume therapy, outcome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Claudia SpiesUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 21 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thermodilution controlled volume management | Experimental | Device: Picco- thermodilution catheterVolume management based on parameters: GEDI, ELWI, CI |
| Volume management based on surviving sepsis campaign | Active comparator | Device: Picco- thermodilution cathetervolume management based on surviving sepsis campaign guidelines: CVP, Urin output, MAP, ScvO2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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:
- Confirmation of SIRS (≥ 48 hours possible), with at least 2 criteria from a-d required:
- Sepsis-induced HYPOTENSION despite adequate volume status (<24h):
Key exclusion criteria (15 listed)
- Therapy limited (DNR-Order)
- Patient moribund
- Pregnancy (positive pregnancy test in women of child bearing age)
- Breast feeding women
- Age < 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Picco- thermodilution catheterTranspulmonary thermodilution and pulse contour analysis with arterial catheter Arterial access via femoral | Device | Thermodilution controlled volume management, Volume management based on surviving sepsis campaign |
Primary outcome
Duration of septic shock
Time frame: 6 months
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
4 secondary outcomes
28 day mortality
Time frame: max 28 Tage
90 and 180 days mortality
Time frame: max 180 days
Intensive care mortality
Time frame: max 28 days
Frequency of arterial hypoperfusion in the extremity of the thermodilution
Time frame: max. 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2014.
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Longitudinal Trajectories of Myocardial Work in Patients With Sepsis
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Sepsis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudia D Spies, MD, Prof. study director
Dept. of Anesthesiology and Intensive Care Medicine, CCM and CVK, Charité - Universitaetsmedizin Berlin
Michael Sander, MD, Prof. principal investigator
Dept. of Anesthesiology and Intensive Care Medicine, CCM and CVK, Charité - Universitaetsmedizin Berlin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Picco- thermodilution catheter in people with Septic Shock and Volume Status, run by Claudia Spies at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of septic shock (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2014.