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Efficacy of Early Norepinephrine Administration and Rapid Dose Adjustment in Adult Septic Shock Patients: A Multicenter Randomized Controlled Trial
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
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok Noi, Bangkok, Thailand
Kalasin Hospital
Kalasin, Changwat Kalasin, Thailand
Khon Kaen hospital
Khon Kaen, Changwat Khon Kaen, Thailand
Udon Thani Hospital
Udon Thani, Changwat Udon Thani, Thailand
Hatyai Hospital
Hat Yai, Hat Yai, Thailand
Maharaj Nakhon Si Thammarat Hospital
Nakhon Si Thammarat, ์Nakhon Si Thammarat, Thailand
Start Date
January 1, 2026
Primary Completion Date
January 1, 2028
Completion Date
March 1, 2028
Last Updated
January 21, 2026
600
ESTIMATED participants
Early norepinephrine administration and rapid dose adjustment
DRUG
Control
DRUG
Lead Sponsor
Siriraj Hospital
Collaborators
NCT04955210
NCT04850456
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07179276