Early Norepinephrine Administration and Rapid Dose Adjustment
NCT ID: NCT07343206
Last Updated: 2026-01-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
600 participants
INTERVENTIONAL
2026-01-31
2028-03-31
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
Early norepinephrine administration and rapid dose adjustment
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.
Control
Placebo (D5W 250 mL) with an identical dosing schedule. Rescue norepinephrine available via a separate line. Same monitoring protocols.
Control
Placebo (D5W 250 mL) with an identical dosing schedule. Rescue norepinephrine available via a separate line. Same monitoring protocols.
Interventions
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Early norepinephrine administration and rapid dose adjustment
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.
Control
Placebo (D5W 250 mL) with an identical dosing schedule. Rescue norepinephrine available via a separate line. Same monitoring protocols.
Eligibility Criteria
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Inclusion Criteria
* Sepsis: SOFA ≥2 with suspected infection
* Mean arterial pressure \<65 mmHg
* Diagnosed within 3 hours
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Maharaj Nakorn Si Thammarat
UNKNOWN
Kalasin Hospital
OTHER
Khon Kaen Hospital
OTHER_GOV
Udon Thani Regional Hospital
UNKNOWN
Hat Yai Hospital
UNKNOWN
Siriraj Hospital
OTHER
Responsible Party
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Wasin Pansiritanachot
Lecturer
Principal Investigators
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Chairat Permpikul, Professor
Role: PRINCIPAL_INVESTIGATOR
Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Si 930/2025
Identifier Type: -
Identifier Source: org_study_id
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