An interventional study of Early norepinephrine administration and rapid dose adjustment and Control in Sepsis and Septic Shock, sponsored by Siriraj Hospital. Recruiting at 6 sites in Thailand. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-22.
Sponsored by Siriraj Hospital · Not applicable, Interventional, and Treatment
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:
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:
1,078 studies on the registry are indexed under Shock, Septic; 232 are open to participants now.
This study's planned enrollment of 600 is above the median of 79 across 636 interventional studies indexed under Shock, Septic.
Browse Shock, Septic studies →Siriraj Hospital is the lead sponsor of 95 studies on the registry; 32 are open to participants now.
Compared within Shock, Septic, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Sepsis. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Early norepinephrine administration and rapid dose adjustment
Placebo (D5W 250 mL) with an identical dosing schedule. Rescue norepinephrine available via a separate line. Same monitoring protocols.
Drug: Control
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.
Placebo (D5W 250 mL) with an identical dosing schedule. Rescue norepinephrine available via a separate line. Same monitoring protocols.
28-day survival
Survival at 28-day after enrollment. Telephone follow-up for patients who are discharged before 28 days.
Time frame: From enrollment to 28 days after enrollment
Number of participants with shock control achieved
Shock control defined as mean arterial pressure greater than 65 mmHg combined with urine output greater than 0.5 milliliters per kilogram per hour OR lactate clearance greater than 10 percent within 6 hours
Time frame: From enrollment to 6 hours after enrollment
Duration of intensive care unit stay
Days of intensive care unit stay
Time frame: From enrollment to hospital discharge or 90 days (whichever comes first)
Duration of hospital stay
Days of hospital stay
Time frame: From enrollment to hospital discharge or 90 days (whichever comes first)
Duration of mechanical ventilation
Days on mechanical ventilation, including endotracheal tube and tracheostomy
Time frame: From enrollment to hospital discharge or 90 days (whichever comes first)
Duration of renal replacement therapy
Days requiring renal replacement therapy, including continuous renal replacement therapy, intermittent hemodialysis, and peritoneal dialysis, that is newly initiated during this admission. Maintaining chronic hemodialysis is excluded.
Time frame: From enrollment to hospital discharge or 90 days (whichever comes first)
Duration of vasopressor therapy
Days requiring vasopressor therapy
Time frame: From enrollment to hospital discharge or 90 days (whichever comes first)
Time to Achievement of Early Goal-Directed Therapy Targets
Time in hours to achieve ALL EGDT targets: MAP ≥65 mmHg, urine output ≥0.5 mL/kg/hr, lactate clearance ≥10%, and ScvO₂ ≥70% (when measured)
Time frame: From study drug initiation until achievement of all EGDT targets or up to 6 hours
Cumulative Fluid Volume Administered
Total volume in milliliters of intravenous crystalloid and colloid fluids administered during first 24 hours and first 72 hours Time Frame: At 1 hour, 6 hours, 24 hours (Day 1), 48 hours (Day 2), and 72 hours (Day 3) after treatment initiation
Time frame: Multiple assessments at: - Before randomization (baseline) - 1 hour after study drug initiation - 6 hours after study drug initiation - 24 hours (Day 1) 48 hours (Day 2) 72 hours (Day 3) after study drug initiation
Incidence of Pulmonary Edema
New-onset cardiogenic pulmonary edema or non-cardiogenic pulmonary edema
Time frame: From diagnosis until hospital discharge 90 days or death
Treatment-Related Adverse Events Including Cardiac Arrhythmias
Composite outcome including new-onset arrhythmias (AF, AFL, SVT, VT, VF, AV block, bradycardia), limb/mesenteric ischemia, skin necrosis, and severe hypertension
Time frame: From study drug initiation until hospital discharge or death, assessed 90 days
Plan to share: Undecided — De-identified anonymized patient data will be available upon reasonable request.
No publications or documents are linked to this record.
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