Giving norepinephrine early and adjusting the dose quickly for adults with septic shock
Official title: Efficacy of Early Norepinephrine Administration and Rapid Dose Adjustment in Adult Septic Shock Patients: A Multicenter Randomized Controlled Trial
Run by Siriraj Hospital · NCT07343206 · Data updated 2026-11-12
This trial will test whether starting norepinephrine early and rapidly titrating the dose helps adults with septic shock survive and recover faster.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 600 (estimated) |
| Sponsor | Siriraj Hospital Academic / other |
| Locations | 6 sites (Bangkok Noi, Bangkok and 5 other locations) |
| Status | Recruiting |
| Started | January 1, 2026 |
| Main results expected | January 2028 |
| Study ends | March 2028 |
| Registry record updated | April 22, 2026 |
| Trial ID | NCT07343206 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 or older with suspected infection, SOFA ≥2, mean arterial pressure under 65 mmHg, and diagnosed within three hours who have not already received norepinephrine are the intended participants.
✕Probably not a fit
Patients with do-not-resuscitate orders, pregnancy, prior norepinephrine, severe concurrent acute conditions (for example acute stroke, acute coronary syndrome, pulmonary edema, major trauma, active GI bleeding), end-stage malignancy, peripheral arterial disease, or recurrent shock are excluded and unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults with septic shock diagnosed within three hours (SOFA ≥2 and MAP <65 mmHg) are randomized to receive either early norepinephrine with rapid dose adjustment or placebo with standard sequential resuscitation and rescue norepinephrine as needed. The protocol emphasizes immediate vasopressor initiation and fast titration to achieve hemodynamic targets while tracking fluid use and adverse events. Primary outcomes include 28-day mortality, time to shock control, and total fluid requirements, with safety monitoring for treatment-related harms. Participating sites are tertiary and regional hospitals in Thailand where enrolled patients are treated in the acute care setting.
Why it matters
Potential benefit: If successful, this approach could lower deaths from septic shock, speed shock resolution, and reduce the amount of IV fluid patients need.
How similar studies have gone: Smaller randomized trials and observational studies have suggested early norepinephrine can speed shock control and reduce fluids, but a clear, consistent mortality benefit has not yet been established.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years * Sepsis: SOFA ≥2 with suspected infection * Mean arterial pressure \<65 mmHg * Diagnosed within 3 hours Exclusion Criteria: * Do-not-resuscitate orders * 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
Where it's running
-
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok Noi, Bangkok, Thailand Recruiting -
Kalasin Hospital
Kalasin, Changwat Kalasin, Thailand Recruiting -
Khon Kaen hospital
Khon Kaen, Changwat Khon Kaen, Thailand Recruiting -
Udon Thani Hospital
Udon Thani, Changwat Udon Thani, Thailand Recruiting -
Hatyai Hospital
Hat Yai, Hat Yai, Thailand Recruiting -
Maharaj Nakhon Si Thammarat Hospital
Nakhon Si Thammarat, ์Nakhon Si Thammarat, Thailand Recruiting
Study contacts
- Principal investigator: Chairat Permpikul, Professor — Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University
- Study coordinator: Titaporn Nasaarn, Medical Doctor
- Email: menatitaporn@gmail.com
- Phone: +66 82 429 5514
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Non-invasive hemodynamic guidance for sepsis care on medical wards
This trial tests whether guiding fluid and vasopressor therapy for sepsis using non-invasive hemodynamic measurements works better than standard care.
-
Personalized Fluid Resuscitation in the Emergency Department
This pilot test checks if a quick, non-invasive stroke-volume assessment can help ED doctors tailor IV fluids for septic patients with low blood pressure.
-
Discordance between capillary refill time and oxygen use in septic shock
This study tests whether some septic shock patients can have a normal capillary refill time but still lack tissue oxygen use, to see if that mismatch relates to 28-day survival.
-
Targeting upper-normal magnesium to see if norepinephrine needs drop in septic shock
This trial tests whether keeping magnesium levels at the upper end of normal can reduce the amount and duration of norepinephrine needed in adults with septic shock.
-
Cortisol Levels and Mortality in Septic Shock ICU Patients
This study tests whether cortisol levels can predict death or recovery in adults with sepsis or septic shock in the ICU.
-
oXiris hemofilter use for adults with septic shock and kidney failure
This study tests whether using the oXiris hemofilter during continuous dialysis helps adults with septic shock and acute kidney injury survive and stabilize faster.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.