Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07343206

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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