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Efficacy of Early Norepinephrine Administration and Rapid Dose Adjustment in Adult Septic Shock Patients: A Multicenter Randomized Controlled Trial

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥ 18 years

• Sepsis: SOFA ≥2 with suspected infection

• Mean arterial pressure \<65 mmHg

• Diagnosed within 3 hours

Locations
Other Locations
Thailand
Faculty of Medicine Siriraj Hospital, Mahidol University
RECRUITING
Bangkok Noi
Hatyai Hospital
RECRUITING
Hat Yai
Kalasin Hospital
RECRUITING
Kalasin
Khon Kaen hospital
RECRUITING
Khon Kaen
Maharaj Nakhon Si Thammarat Hospital
RECRUITING
Nakhon Si Thammarat
Udon Thani Hospital
RECRUITING
Udon Thani
Contact Information
Primary
Titaporn Nasaarn, Medical Doctor
menatitaporn@gmail.com
+66 82 429 5514
Backup
Chairat Permpikul, Professor
chairat.per@mahidol.ac.th
+66 81 408 1676
Time Frame
Start Date: 2026-01-01
Estimated Completion Date: 2028-03
Participants
Target number of participants: 600
Treatments
Experimental: Intervention
Norepinephrine 4 mg in 250 mL D5W, initiated at 0.05 mcg/kg/min. Titrate by 0.025 mcg/kg/min every 15 minutes if MAP \<65 mmHg, up to 0.15 mcg/kg/min maximum. Rescue norepinephrine available if needed (separate line). Limb ischemia monitoring every 15 minutes.~Duration: 24 hours.
Sham_comparator: Control
Placebo (D5W 250 mL) with an identical dosing schedule. Rescue norepinephrine available via a separate line. Same monitoring protocols.
Related Therapeutic Areas
Sponsors
Collaborators: Khon Kaen Hospital, Kalasin Hospital, Udon Thani Regional Hospital, Hat Yai Hospital, Maharaj Nakorn Si Thammarat
Leads: Siriraj Hospital

This content was sourced from clinicaltrials.gov