Septic Shocksepsis-coolNCT00527007
External Cooling in Septic Shock Patients
A study testing External cooling in people with Septic Shock, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The rapidity of the resolution of cardiovascular failure has a strong impact on septic shock patients' outcome. The aim of this multicenter randomized controlled trial is to determine whether external cooling might accelerate improvement in cardiovascular function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock
- What is being tested?
- External cooling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2007to Mar 2010
- 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
- Documented or suspected infection
- Body temperature > 38.3°C
- Persistent hypotension despite fluid resuscitation and need for vasopressor infusion to maintain mean arterial pressure > 65 mmHg.
- Invasive mechanical ventilation
- Intravenous sedation
Who cannot join
- Temperature > 41°C
- Age < 18 years
- Pregnancy
- Continuous renal replacement therapy
- Paracetamol or NSAI administration within 6 hours before inclusion
- Need for paracetamol and/or NSAI therapy during the study period
- Burns or Lyell syndrome
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of External Cooling in Septic Shock Patients
The rapidity of the resolution of cardiovascular failure has a strong impact on septic shock patients' outcome. The aim of this multicenter randomized controlled trial is to determine whether external cooling might accelerate improvement in cardiovascular function.
Read the detailed description
Patients suffering from septic shock need fluid resuscitation and vasopressor therapy for restoring cardiovascular function. Corticosteroids and activated protein C have been both proposed for vascular tone improvement. While external cooling is largely used in ICU febrile patients, benefits and risks of fever treatment during sepsis have been rarely studied. Surveys show that external cooling is usual care applied by nurses themselves without medical order.
The control of thermal balance might decrease cardiac output and oxygen consumption, and reduce serum lactate concentration. However some animal studies have suggested that fever might be essential for host defence. This trial compares two strategies of fever management on vasopressor dependence in septic shock patients. In the treatment group, external cooling is applied to normalize the body temperature between 36°5 C and 37°C, while control patients receive any fever treatment. The goal for mean arterial pressure is the same in the two groups and vasopressor withdrawal is determined by similar algorithm.
- Conditions
- Septic Shock
- Being tested
- External cooling
- Keywords
- Vasopressor, Epinephrine, Norepinephrine, Cooling, Fever, ICU
- Medical subject headings
- Shock, Septic, Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External coolingOther
External cooling
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Other: External cooling |
| B | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with a decrease in the dose of vasopressors of 50% 48 hours after enrolment
Measured: 48 hours after enrolment
Secondary outcomes (3)
Maximal dose of vasopressors
Measured: within 48 hours after enrolment
SOFA score evolution
Measured: on Day 3, Day 7, Day 14
Number of vasopressor free days in the ICU
Measured: during the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2007 (estimated)
- Study startOct 2007
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Investigators
- Frederique SCHORTGEN, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00527007
- Sponsor's protocol ID
- SCR06012
- Acronym
- sepsis-cool
- Status last verified
- Aug 2008
- First submitted
- 6 Sep 2007
- Last updated
- 22 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Schortgen F, Charles-Nelson A, Bouadma L, Bizouard G, Brochard L, Katsahian S. Respective impact of lowering body temperature and heart rate on mortality in septic shock: mediation analysis of a randomized trial. Intensive Care Med. 2015 Oct;41(10):1800-8. doi: 10.1007/s00134-015-3987-7. Epub 2015 Jul 23.
PubMed 26202042
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of External Cooling in Septic Shock Patients
- ClinicalTrials.gov ID
- NCT00527007
- Acronym / sponsor ID
- sepsis-cool / SCR06012
- Conditions
- Septic Shock
- Keywords
- Vasopressor, Epinephrine, Norepinephrine, Cooling, Fever, ICU
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 10 Sep 2007 (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.
The rapidity of the resolution of cardiovascular failure has a strong impact on septic shock patients' outcome. The aim of this multicenter randomized controlled trial is to determine whether external cooling might accelerate improvement in cardiovascular function.
Detailed description
Patients suffering from septic shock need fluid resuscitation and vasopressor therapy for restoring cardiovascular function. Corticosteroids and activated protein C have been both proposed for vascular tone improvement. While external cooling is largely used in ICU febrile patients, benefits and risks of fever treatment during sepsis have been rarely studied. Surveys show that external cooling is usual care applied by nurses themselves without medical order.
The control of thermal balance might decrease cardiac output and oxygen consumption, and reduce serum lactate concentration. However some animal studies have suggested that fever might be essential for host defence. This trial compares two strategies of fever management on vasopressor dependence in septic shock patients. In the treatment group, external cooling is applied to normalize the body temperature between 36°5 C and 37°C, while control patients receive any fever treatment. The goal for mean arterial pressure is the same in the two groups and vasopressor withdrawal is determined by similar algorithm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Other: External cooling |
| B | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Documented or suspected infection
- Body temperature > 38.3°C
- Persistent hypotension despite fluid resuscitation and need for vasopressor infusion to maintain mean arterial pressure > 65 mmHg.
- Invasive mechanical ventilation
- Intravenous sedation
Key exclusion criteria (7 listed)
- Temperature > 41°C
- Age < 18 years
- Pregnancy
- Continuous renal replacement therapy
- Paracetamol or NSAI administration within 6 hours before inclusion
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 |
|---|---|---|
| External coolingExternal cooling | Other | A |
Primary outcome
Number of patients with a decrease in the dose of vasopressors of 50% 48 hours after enrolment
Time frame: 48 hours after enrolment
3 secondary outcomes
Maximal dose of vasopressors
Time frame: within 48 hours after enrolment
SOFA score evolution
Time frame: on Day 3, Day 7, Day 14
Number of vasopressor free days in the ICU
Time frame: during the study
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 22 Jul 2010.
- Derived from this study: PubMed 26202042Schortgen F, Charles-Nelson A, Bouadma L, Bizouard G, Brochard L, Katsahian S. Respective impact of lowering body temperature and heart rate on mortality in septic shock: mediation analysis of a randomized trial. Intensive Care Med. 2015 Oct;41(10):1800-8. doi: 10.1007/s00134-015-3987-7. Epub 2015 Jul 23.
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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.
Frederique SCHORTGEN, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing External cooling in people with Septic Shock, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 5 inclusion and 7 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 22 Jul 2010. 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 France. 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?
Number of patients with a decrease in the dose of vasopressors of 50% 48 hours after enrolment (time frame: 48 hours after enrolment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00527007, which also lists 1 linked publication.
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 22 Jul 2010.