Could a common sedative save lives in septic shock?
NCT ID NCT03953677
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether a sedative drug called dexmedetomidine could help restore blood pressure control in patients with severe septic shock that does not respond to standard treatments. The trial involved 32 adults in intensive care. The goal was to see if the drug could improve the body's response to a blood-pressure-raising medication, potentially reducing the risk of death.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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32 people
The number who actually took part.
- Started
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Oct 2019
- Finished
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Mar 2023
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age ≥ 18 years old * Septic shock, defined by the "Sepsis-3" criteria * proven or suspected infection, with modification of the SOFA score ≥ 2 points, * with persistent hypotension requiring vasopressors to maintain MAP ≥ 65 mmHg * and a serum lactate level \> 2 mmol/L despite adequate vascular filling * Adequate vascular filling: ≥ 30ml/kg, OR absence of preload-dependency criteria at time of assessment (respiratory variability of the inferior vena cava, passive leg lift, pulsed pressure variation) * Catecholamine resistance, defined by the need for a dose of norepinephrine ≥ 0,5 µg/kg/min for more than 2 consecutive hours within 24 hours of admission to intensive care unit * persistence of circulatory failure with at least one of the following criteria present in the 2 hours prior to randomisation: hyperlactatemia \> 2mmol/l, and/or mottling (≥ 1 score), and/or oliguria (diuresis \< 0,5 ml/kg/h over the last 2 hours) * Invasive Mechanical ventilation * Under sedation by midazolam or propofol * Informed consent obtained from a relative for patient included in an emergency * Patient affiliated to the national health insurance system Exclusion Criteria: * Cardiac arrest before inclusion and occurring before septic shock criteria are met * Cardiac index \< 2.2 l/min/m² after volume correction, or left ventricular ejection fraction \< 40% on echocardiography * Bradycardia \< 55 bpm (apart from treatment with β-blocker) or 2nd or 3rd degree BAV not equipped * Proven or suspected decompensation of coronary heart disease * Acute cerebrovascular condition within 2 weeks prior to inclusion * Severe hepatic insufficiency with TP and factor V \<50% in the absence of DIC (disseminated intravascular coagulation) * Patient on adrenaline or vasopressors at the time of inclusion (epinephrine or vasopressin stopped prior to inclusion is not a criterion for non-inclusion) * Patient on non-selective MAOI iproniazid within 15 days of inclusion * Patient for whom a decision has been made to limit the use of therapies * Hypersensitivity to dexmedetomidine or phenylephrine * Patient on dexmedetomidine before inclusion * Person subject to a legal protection measure (curatorship, guardianship) * Person subject to limited judicial protection * Pregnant, parturient or breastfeeding woman * Patient with suspected or confirmed mesenteric ischemia
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Chu Dijon Bourgogne
Dijon, 21000, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Bedside eye scans may reveal hidden blood flow problems in septic shock
- Can two blood markers catch sepsis before it turns deadly?
- Two cheap blood ratios put to the test as sepsis death predictors
- Can a bedside ultrasound predict which septic shock patients will stop breathing on their own?
- Can a computer model speed up sepsis blood tests?