Effects of Dexmedetomidine on Sublingual Microcirculation and Vascular Waterfall Phenomenon in Patients With Septic Shock
Study Details
- Unmapped
- Drug: Dexmedetomidine Intravenous Infusion
- Age 18-85 years.
- Diagnosis of septic shock according to Sepsis-3 criteria, defined as suspected or documented infection with vasopressor requirement to maintain mean arterial pressure ≥65 mmHg and serum lactate \>2 mmol/L after adequate fluid resuscitation.
- Enrollment within 24 hours after diagnosis of septic shock in the ICU.
- Receiving invasive mechanical ventilation.
- Receiving continuous intravenous sedative and/or analgesic therapy other than dexmedetomidine before enrollment, with a clinical decision to add dexmedetomidine for sedation management.
- Continuous norepinephrine infusion at enrollment.
- PiCCO catheter in place and PiCCO-based hemodynamic monitoring available before dexmedetomidine initiation.
- Written informed consent obtained from the patient or legally authorized representative.
- Shock primarily caused by non-septic etiologies, including cardiogenic, hypovolemic, obstructive, hemorrhagic, or anaphylactic shock.
- Expected death or withdrawal of life-sustaining treatment within 24 hours.
- Known allergy or hypersensitivity to dexmedetomidine.
- Severe bradycardia or clinically significant conduction abnormality before enrollment, including heart rate \<50 beats/min, second-degree or third-degree atrioventricular block, sick sinus syndrome, or other conduction abnormality without a functioning pacemaker.
- Severe uncontrolled arrhythmia, acute coronary syndrome, or clinically significant myocardial ischemia before enrollment.
- Severe hemodynamic instability judged unsuitable for dexmedetomidine by the treating physician, including refractory hypotension or rapidly escalating vasopressor requirement.
- Severe hepatic dysfunction judged by the investigator to substantially increase the risk of dexmedetomidine accumulation or adverse effects.
- Conditions interfering with sublingual microcirculatory assessment, including major oral or sublingual lesions, active oral bleeding, inability to access the sublingual area, or poor baseline image quality.
- Pregnancy or lactation.
- Participation in another interventional clinical trial that may affect study outcomes or safety.
Protocol Summary
This study is looking at how safe it is to switch from emicizumab to Mim8, in people with haemophilia A. Mim8 is a new medicine that is used to prevent bleeding episodes in people with haemophilia A. Mim8 works by replacing the function of the missing clotting factor VIII (FVIII). Mim8 will be injected under the skin using a pen-injector either once every week, once every two weeks or once every month. The participants will be trained in using the pen injector. The participants can choose themselves, in collaboration with the study doctor how often they get Mim8 in this study. When the participant will get their first Mim8 injection depends on their current treatment with emicizumab. The participants will get their first Mim8 injection at Visit 2. Participants will have between 6 and 27 Mim8 injections. The total number of injections participants will have depends on their dosing frequency. The study will last for about 6-12 months. While taking part in this study, there are some restrictions about what medicine participant can use. The study doctor will tell the participants more about this. In case the participants experience bleeds, these can be treated with additional haemostatic medicine as agreed with the study doctor. Female participants cannot take part if they are pregnant, breast-feeding or plan to get pregnant during the study period.