Actively Recruiting
Early Norepinephrine Administration and Rapid Dose Adjustment
Led by Siriraj Hospital · Updated on 2026-04-22
600
Participants Needed
6
Research Sites
112 weeks
Total Duration
On this page
Sponsors
S
Siriraj Hospital
Lead Sponsor
M
Maharaj Nakorn Si Thammarat
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Early Norepinephrine Administration and Rapid Dose Adjustment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Sepsis with SOFA score of 2 or more and suspected infection
- Mean arterial pressure less than 65 mmHg
- Septic shock diagnosed within 3 hours
You will not qualify if you...
- Do-not-resuscitate orders
- Pregnancy
- Severe concurrent conditions including acute stroke, acute coronary syndrome, acute pulmonary edema, status asthmaticus, active gastrointestinal bleeding, status epilepticus, severe burn, severe trauma, fatal drug overdose, end-stage malignancy
- Peripheral arterial disease
- Prior norepinephrine administration
- Recurrent shock in the same patient
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Trial Site Locations
Total: 6 locations
1
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok Noi, Bangkok, Thailand, 10700
Actively Recruiting
2
Kalasin Hospital
Kalasin, Changwat Kalasin, Thailand, 46000
Actively Recruiting
3
Khon Kaen hospital
Khon Kaen, Changwat Khon Kaen, Thailand, 4000
Actively Recruiting
4
Udon Thani Hospital
Udon Thani, Changwat Udon Thani, Thailand, 41000
Actively Recruiting
5
Hatyai Hospital
Hat Yai, Hat Yai, Thailand, 90110
Actively Recruiting
6
Maharaj Nakhon Si Thammarat Hospital
Nakhon Si Thammarat, ์Nakhon Si Thammarat, Thailand, 8000
Actively Recruiting
Research Team
T
Titaporn Nasaarn, Medical Doctor
CONTACT
C
Chairat Permpikul, Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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