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| Name | Class |
|---|---|
| Maharaj Nakorn Si Thammarat | UNKNOWN |
| Kalasin Hospital | OTHER |
| Khon Kaen Hospital | OTHER_GOV |
| Udon Thani Regional Hospital |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | 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 | Sham Comparator | Placebo (D5W 250 mL) with an identical dosing schedule. Rescue norepinephrine available via a separate line. Same monitoring protocols. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early norepinephrine administration and rapid dose adjustment | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 28-day survival | Survival at 28-day after enrollment. Telephone follow-up for patients who are discharged before 28 days. | From enrollment to 28 days after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From enrollment to 6 hours after enrollment |
| Duration of intensive care unit stay |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Titaporn Nasaarn, Medical Doctor | Contact | +66 82 429 5514 | menatitaporn@gmail.com | |
| Chairat Permpikul, Professor | Contact | +66 81 408 1676 | chairat.per@mahidol.ac.th |
| Name | Affiliation | Role |
|---|---|---|
| Chairat Permpikul, Professor | Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine Siriraj Hospital, Mahidol University | Recruiting | Bangkok Noi | Bangkok | 10700 | Thailand |
De-identified anonymized patient data will be available upon reasonable request.
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| D012772 | Shock, Septic |
| D007022 | Hypotension |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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| UNKNOWN |
| Hat Yai Hospital | UNKNOWN |
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|
| Control | Drug | Placebo (D5W 250 mL) with an identical dosing schedule. Rescue norepinephrine available via a separate line. Same monitoring protocols. |
|
Days of intensive care unit stay |
| From enrollment to hospital discharge or 90 days (whichever comes first) |
| Duration of hospital stay | Days of hospital stay | From enrollment to hospital discharge or 90 days (whichever comes first) |
| Duration of mechanical ventilation | Days on mechanical ventilation, including endotracheal tube and tracheostomy | 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. | From enrollment to hospital discharge or 90 days (whichever comes first) |
| Duration of vasopressor therapy | Days requiring vasopressor therapy | 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) | 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 | 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 | 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 | From study drug initiation until hospital discharge or death, assessed 90 days |
| Kalasin Hospital | Recruiting | Kalasin | Changwat Kalasin | 46000 | Thailand |
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| Khon Kaen hospital | Recruiting | Khon Kaen | Changwat Khon Kaen | 4000 | Thailand |
|
| Udon Thani Hospital | Recruiting | Udon Thani | Changwat Udon Thani | 41000 | Thailand |
|
| Hatyai Hospital | Recruiting | Hat Yai | Hat Yai | 90110 | Thailand |
|
| Maharaj Nakhon Si Thammarat Hospital | Recruiting | Nakhon Si Thammarat | ์Nakhon Si Thammarat | 8000 | Thailand |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |