Status:
ENROLLING_BY_INVITATION
Early Norepinephrine in Trauma Patients With Hemorrhagic Shock
Lead Sponsor:
Visarat Palitnonkiat
Collaborating Sponsors:
Siriraj Hospital
Conditions:
Trauma, Multiple
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
The goal of this clinical trial is to learn if norepinephrine works to treat trauma patients with hemorrhagic shock. It will also learn about the safety of norepinephrine. The main questions it aims t...
Detailed Description
Study Population: Adult trauma patients with hemorrhagic shock Inclusion Criteria: 1. Adult trauma patients aged 18 to 65 years 2. Significant bleeding from traumatic events including 1. Exsangu...
Eligibility Criteria
Inclusion
- Adult trauma patients aged 18 to 65 years
- Significant bleeding from traumatic events including
- Exsanguinous external bleeding (500 ml or more), or
- Evidence of internal bleeding (e.g., FAST positive, hemothorax, or bleeding seen on CT scan)
- Hemorrhagic shock is defined as:
- Hypotensive event suspected from hemorrhagic shock, characterized by
- Systolic blood pressure less than 90 mmHg,
- Mean arterial pressure less than 65 mmHg, or
- A decrease in blood pressure from baseline more than 30 mmHg (as recorded in the trauma bay, resuscitation room of the emergency department at Ramathibodi Hospital, trauma unit at Siriraj Hospital, or trauma ward/ ICU) OR
- Signs of shock, including:
- Capillary refill time greater than 2 seconds,
- Base excess less than -6 mEq/L,
- Lactate level greater than 2 mmol/L)
Exclusion
- Prehospital cardiopulmonary resuscitation or cardiopulmonary resuscitation at the trauma bay.
- Persistent shock for more than 12 hours prior to randomization.
- Severe traumatic brain injury with Glasgow Coma Scale (GCS) score less than 9 (GCS 3-8)
- Traumatic limb injury with acute limb ischemia
- A history of limb ischemia, chronic heart disease, chronic lung disease, or chronic renal disease
- Pregnant patients
- Documented "Do Not Resuscitate" (DNR) order or who declined life-sustaining intervention before randomization
- Allergic to norepinephrine or contraindications for its use (e.g., peripheral vascular thrombosis, mesenteric thrombosis, and fatal tachyarrhythmia)
- Current use of ergotamine, monoamine oxidase inhibitors (MAOIs), or tricyclic antidepressants (TCAs)
- Prior vasopressor administration before randomization.
- Weight less than 30 kilograms (Extremely low body weight may increases the risk of weight-based dosing issues)
Key Trial Info
Start Date :
May 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 18 2027
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06977659
Start Date
May 20 2025
End Date
August 18 2027
Last Update
May 18 2025
Active Locations (2)
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1
Faculty of Medicine Ramathibodi Hospital
Bangkok, Thailand, 10400
2
Faculty of Medicine Siriraj Hospital
Bangkok, Thailand, 10700