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Recruiting Not applicable NCT07343206

Early Norepinephrine Administration and Rapid Dose Adjustment

No applicable phase (e.g. observational)
Conditions: Sepsis Septic Shock

Sponsor: Siriraj Hospital

trial.available_in: БГ
Overview
The goal of this clinical trial is to determine whether early initiation of norepinephrine with rapid dose adjustment improves clinical outcomes in adult patients with septic shock. The study aims to evaluate the effect of early norepinephrine administration on mortality, hemodynamic stabilization, and resuscitation efficiency in adults aged 18 years and older diagnosed with septic shock. The main questions it aims to answer are: * Does early norepinephrine administration with rapid dose titration reduce 28-day mortality compared with standard treatment? * Does early norepinephrine administration with rapid dose tiration lead to faster shock control and reduced fluid requirements without increasing treatment-related adverse events? Researchers will compare early norepinephrine administration with rapid dose adjustment to placebo with standard sequential resuscitation and rescue norepinephrine as needed to see if early vasopressor initiation improves survival, shock resolution, and safety outcomes. Participants will: * Receive either norepinephrine or placebo infusion initiated within one hour of septic shock diagnosis, with dose adjustment every 15 minutes according to a standardized protocol * Undergo close hemodynamic and safety monitoring, including frequent vital sign assessment and limb perfusion evaluation * Receive standard sepsis care, including fluid resuscitation, antibiotics, and organ support as clinically indicated * Be followed for clinical outcomes and adverse events for up to 28 days after enrollment
Who can participate
Inclusion Criteria: * Age ≥ 18 years * Sepsis: SOFA ≥2 with suspected infection * Mean arterial pressure \<65 mmHg * Diagnosed within 3 hours Exclusion Criteria: * Do-not-resuscitate orders * Pregnancy * Severe concurrent conditions (acute stroke, acute coronary syndrome, acute pulmonary edema, status asthmaticus, active gastrointestinal bleeding, status epilepticus, severe burn, severe trauma, and fatal drug overdose, End-stage malignancy * Peripheral arterial disease * Prior norepinephrine administration * Recurrent shock in the same patient
Interventions
Early norepinephrine administration and rapid dose adjustment
DRUG
Control
DRUG
Locations 6
Thailand (6)
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok Noi , Bangkok
Wasin Pansiritanachot, Medical Doctor
Hatyai Hospital
Hat Yai , Hat Yai
Kalasin Hospital
Kalasin , Changwat Kalasin
Khon Kaen hospital
Khon Kaen , Changwat Khon Kaen
Maharaj Nakhon Si Thammarat Hospital
Nakhon Si Thammarat , ์Nakhon Si Thammarat
Udon Thani Hospital
Udon Thani , Changwat Udon Thani
Technical details
Status
Recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
01.01.2026
Completion date
01.03.2028
Registry ID
NCT07343206
Source
clinicaltrials.gov
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