Evaluating Multiple Treatments and Strategies for Sepsis in Adaptive Platform trial

JRCT ID: jRCT1031240424

Registered date:22/10/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Sepsis
• Date of first enrollment: 22/10/2024
• Target sample size: 1240
• Study type: Interventional

Intervention(s)

Intervention is defined in each domain, which is descrived in each domain protocol.

Hemodynamic management domain:
Patient recieves either intervention or control treatmet as folows for 48 hours or until discharge from ICU, whichever comes earlier. In both treatments, when heart rate becomes less than 40 bpm or higher than or equal to 140 bpm, any treatments, including medication, are initiated as appropriated in the decision of a treating physician.
Intervention: Continous intravenous administration of landiolol is initatated with 1mcg/kg/min. After 15-30 min of hemodynamic monitoring confirm no deterioration of hemodynamics, landiolol administration is increased to 2mcg/kg/min. Target heart rate is set as 80-129bpm. When heart rate decreases to lower than 60bpm, landiolol administration is stopped.
Control: No medication is administered in order to control heart rate.

Infection control domain with antibiotic-containing dressing:
Patient recieves either intervention or control treatmet on the newly placed catheter as folows until catheter is removed. Dressing is replaced every 7 days or when dressing is not appropriately functioning within 7 days. Replaced dressing follows the initial assigned treatment. Another newly inserted catheter during intensive care for sepsis also follows the initial assigned treatment.
Intervention: Catheter-insertion site is covered by chlorhexidine-containing dressing
Control: Catheter-insertion site is covered by dressing that does not have disinfection/antibacterial effects

Outcome(s)

Primary Outcome

90-day survival from the initiation of intensive care for sepsis

Hemodynamic management domain:
Composite outcome of mortality and/or ischemic/thrombotic major vascular event at 30 days from the initiation of intensive care for sepsis

Infection control domain with antibiotic-containing dressing:
Catheter colonization

Secondary Outcome

Hospital-/ICU-/Ventilator-/RRT-free days up to 30 days from the initiation of intensive care for sepsis
30-day mortality

Hemodynamic management domain:
In-hospital mortality
30-day survival to discharge to home
Newly developed arrhythmia up to 30 days from the initiation of intensive care for sepsis and its duration
Ischemic/thrombotic major vascular event at 30 days from the initiation of intensive care for sepsis
Vasopressor-free days up to 30 days
Arrhythmia required electrical treatment

Infection control domain with antibiotic-containing dressing:
Incidence rate of major catheter-related infections
Clinical information at 30 days/90 days after the start of intensive care
Length of antibiotic use
Hospitalization medical expenses
Adverse events related to chlorhexidine and/or catheter

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Aged 18 years or older
Diagnosed as sepsis (based on Sepsis-3 criteria)
Requiring intensive care
Written consent has been obtained from the subject or proxy

Hemodynamic management domain:
Mild tachycardia (HR 95-129bpm) within 72 hours after the initiation of intensive care
(The start of intensive care is defined as the time of admission to the intensive care unit (ICU) or when the attending physician begins frequent monitoring of consciousness, respiration, and heart rate if the patient is not admitted to the ICU.)

Infection control domain with antibiotic-containing dressing:
Central venous line (including hemodialysis catheter, peripherally inserted central venous catheter) is newly inserted

Exclude criteria

Participation in another clinical trial requiring a treatment intervention that is considered to have an interaction with any of intervention of this trial(Thoroughly assess the potential for interaction scientifically and statistically.)
At the time of diagnosis as sepsis, withhold/withdrwal is determined
Detainees in correctional facilities and immigration detention centers
Ineligible for, or not participating in, any domain studies
Physician in charge considers the particitation is inappropriate

Hemodynamic management domain:
Ventricular tachycardia or ventricular fibrillation
Antiarrhythmic medication is being administered intravenously
Landiolol is contraindicated
Highly anticipated to die within 24 h
72 hours past after the initiation of intensive care for sepsis
Previously participated in this particular domain

Infection control domain with antibiotic-containing dressing:
Allergy to chlorhexidine
Having skin disease in the whole body
Having skin lesion at the site of catheter insertion
Catheter is inserted as the exchange over the guidewire
Antibiotics impregnated catheter is used
72 hours past after the initiation of intensive care for sepsis
Previously participated in this particular domain

Related Information

• Primary Sponsor: Yamamoto Ryo
• Secondary Sponsor: Kushimoto Shigeki,Japanese Association for Acute Medicine