BridgeMD
Compares treatment options for Septic Shock
Official title Comparison of Landiolol Versus Standard of Care for Prevention of Mortality in Patients Hospitalized for a Septic Shock With Hypercontractility
ClinicalTrials.gov ID: NCT04748796
What this study is testing
What is Landiolol?
Landiolol is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for septic shock.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Several data emphasize the relation between tachycardia (\>90/min) and high mortality during septic shock. The investigators previously demonstrated the high mortality associated with hypercontractility, tachycardia and the presence of a left ventricular obstruction.
- Phase 3: a large, late-stage study
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
- Age ≥ 18 years old
- Patient admitted for a septic shock (according to the SEPSIS3 definition: sepsis with persisting hypotension (MAP\ 65mmHg and having a serum lactate...
- Patient who received at least 30ml/kg of fluid and absence of fluid responsiveness
- Left ventricular ejection fraction \>65% (visual or Simpson method using echocardiography)
- Tachycardia \>100 bpm in sinus rhythm with a MAP 65mmHg for more than 1 hour
You likely can't join if
- Patients with inclusion criteria already present for more than 36 hours
- Patient treated with Dobutamine, adrenaline or isoprenaline
- Patient currently treated with beta blockers (previous home betablocker treatment is not an exclusion criteria)
- Supra ventricular (atrial fibrillation or flutter) or ventricular arrhythmias
- Patients with any form of cardiac pacing
- Sick sinus syndrome
See the full eligibility criteria
- Age ≥ 18 years old
- Patient admitted for a septic shock (according to the SEPSIS3 definition: sepsis with persisting hypotension (MAP\ 65mmHg and having a serum lactate level \>2 mmol/L
- Patient who received at least 30ml/kg of fluid and absence of fluid responsiveness
- Left ventricular ejection fraction \>65% (visual or Simpson method using echocardiography)
- Tachycardia \>100 bpm in sinus rhythm with a MAP 65mmHg for more than 1 hour
- Patient receiving invasive mechanical ventilation
- Patients adapted to the ventilator under sedation and analgesia
- Written informed consent
- Patient covered by French national health insurance
- Patients with inclusion criteria already present for more than 36 hours
- Patient treated with Dobutamine, adrenaline or isoprenaline
- Patient currently treated with beta blockers (previous home betablocker treatment is not an exclusion criteria)
- Supra ventricular (atrial fibrillation or flutter) or ventricular arrhythmias
- Patients with any form of cardiac pacing
- Sick sinus syndrome
- Severe atrioventricular (AV) nodal conductance disorders (without pacemaker): 2nd or 3rd degree AV block
- Known pulmonary hypertension
- ScVO2 \<70%
- Moribund
- Cardiac arrest
- Non-treated phaeochromocytoma
- Acute asthmatic attack
- Pregnant or breastfeeding woman
- Patient deprived of liberty by administrative or judicial decision or placed under judicial protection (guardianship or supervision),
- Age \<18 years
- Hypersensitivity to the active substance or to any of the excipients
- Severe bradycardia (less than 50 beats per minute)
- Cardiogenic shock
- Severe hypotension
- Decompensated heart failure when considered not related to the arrhythmia
- Severe, uncorrectable metabolic acidosis
- Presence of significant bleeding, or
- Acute respiratory distress defined by increased oxygen dependency, polypnea \> 30 /min, signs of struggle (pulling, thoraco-abdominal sway) if the patient is not intubated and ventilated.
The study team makes the final eligibility decision.
Where it's taking place
- Amiens, France
Compensation & support
A stipend or compensation may be offered.
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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. 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.