NCT07343206 Early Norepinephrine Administration and Rapid Dose Adjustment
| NCT ID | NCT07343206 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Siriraj Hospital |
| Condition | Sepsis |
| Study Type | INTERVENTIONAL |
| Enrollment | 600 participants |
| Start Date | 2026-01-01 |
| Primary Completion | 2028-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 600 participants in total. It began in 2026-01-01 with a primary completion date of 2028-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility Criteria
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
Contact & Investigator
Chairat Permpikul, Professor
PRINCIPAL INVESTIGATOR
Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University
Frequently Asked Questions
Who can join the NCT07343206 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Sepsis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07343206 currently recruiting?
Yes, NCT07343206 is actively recruiting participants. Contact the research team at menatitaporn@gmail.com for enrollment information.
Where is the NCT07343206 trial being conducted?
This trial is being conducted at Bangkok Noi, Thailand, Kalasin, Thailand, Khon Kaen, Thailand, Udon Thani, Thailand and 2 additional locations.
Who is sponsoring the NCT07343206 clinical trial?
NCT07343206 is sponsored by Siriraj Hospital. The principal investigator is Chairat Permpikul, Professor at Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University. The trial plans to enroll 600 participants.