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Early Norepinephrine Administration and Rapid Dose Adjustment

RecruitingNAAges 18 Years - anyAllSiriraj Hospital
NCT07343206 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 norepi

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📋 Eligibility rules (as published)
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
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What it tests

  • Early norepinephrine administration and rapid dose adjustment
  • Control
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Where

6 sites
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok Noi, Thailand
Kalasin Hospital
Kalasin, Thailand
Khon Kaen hospital
Khon Kaen, Thailand
Udon Thani Hospital
Udon Thani, Thailand
Hatyai Hospital
Hat Yai, Thailand
Maharaj Nakhon Si Thammarat Hospital
Nakhon Si Thammarat, Thailand
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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