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New treatment option for Septic Shock
Official title Fever Control Using External Cooling in Mechanically Ventilated Patients With Septic Shock
ClinicalTrials.gov ID: NCT04494074
What this study is testing
- What it's testing
- The best strategy for managing fever in patients with septic shock remains unknown. In a pilot study, the investigators showed that fever control at normothermia allowed a better control of shock and evolution of organ failures.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Documented or suspected infection either communautary or hospital acquired
- Septic shock defined by the need for vasopressor and lactate\>2 mmol/l despite adequate fluid resuscitation (sepsis-3 definition)
- Patients under invasive mechanical ventilation
- Body core temperature\>38.3°C
- Intravenous sedation or opioids
You likely can't join if
- Cardiac arrest within previous 7 days
- Acute brain injury within previous 7 days
- Extensive burns or epidermal necrolysis
- \<18 years old
- Body core temperature \>41°C
- Under legal guardianship
See the full eligibility criteria
- Documented or suspected infection either communautary or hospital acquired
- Septic shock defined by the need for vasopressor and lactate\>2 mmol/l despite adequate fluid resuscitation (sepsis-3 definition)
- Patients under invasive mechanical ventilation
- Body core temperature\>38.3°C
- Intravenous sedation or opioids
- Ongoing antimicrobial treatment and/or intervention for infection source control
- Attending physician confirms clinical equipoise without substantial risk if the patient participates in the trial
- Informed consent of next of kin/other designated person before inclusion or procedure for inclusion in emergency situation
- Cardiac arrest within previous 7 days
- Acute brain injury within previous 7 days
- Extensive burns or epidermal necrolysis
- \<18 years old
- Body core temperature \>41°C
- Under legal guardianship
- No affiliation with the French health-care system
- Pregnancy
- Participation in another treatment study with mortality as the primary endpoint
- An investigator's decision not to resuscitate
- Patient already recruited in the trial
The study team makes the final eligibility decision.
Where it's taking place
- Amiens, France
- Angers, France
- Argenteuil, France
- Belfort, France
- Cholet, France
- Créteil, France
- Dijon, France
- Grenoble, France
- Jossigny, France
- La Roche-sur-Yon, France
- Le Kremlin-Bicêtre, France
- Le Mans, France
- Lens, France
- Libourne, France
- Lyon, France
- Marseille, France
- Metz, France
- Mulhouse, France
- Nantes, France
- Nice, France
+ 9 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amiens, France; Angers, France; Argenteuil, France; Belfort, France; Cholet, France; Créteil, France and 23 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.