Trauma with hemorrhagic shock Trauma Hemorrhagic shock Norepinephrine Vasopressor Mortality
Conditions
Interventions
Norepinephrine bitartrate (Levophed), diluted to 16 mcg/ml concentration in 250 ml 5% Dextrose in Water, administered as continuous IV infusion at 10 ml/hour (approx. 0.05 mcg/kg/min for 50 kg patient
Active Comparator Drug,No Intervention No treatment
Early norepinephrine administration,Standard fluid and blood product resuscitation without norepinephrine
Sponsors
Faculty of Medicine Siriraj Hospital and Faculty of Medicine Ramathibodi Hospital, Mahidol University
Faculty of Medicine Ramathibodi Hospital, Mahidol University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years 2. Significant bleeding from trauma (more than 500 ml external bleeding or internal bleeding confirmed by FAST, CT, hemothorax) 3. Hemorrhagic shock (SBP less than 90 mmHg or MAP less than 65 mmHg or drop more than 30 mmHg from baseline or signs of shock)
Exclusion criteria
Exclusion criteria: 1. Prehospital CPR or CPR at trauma bay 2. Persistent shock more than 12 hours prior randomization 3. Severe traumatic brain injury (GCS less or equal 8) 4. Pregnancy 5. Do Not Resuscitate order or declined life-sustaining interventions 6. Allergy or contraindication to norepinephrine 7. Concurrent use of ergotamine, MAOIs, or tricyclic antidepressants 8. Prior vasopressor administration
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 24-hour mortality 24 hours after randomization Proportion of enrolled patients who die within 24 hours after randomization, assessed by hospital medical record review | — |
Secondary
| Measure | Time frame |
|---|---|
| 30-day mortality 30 days after randomization Proportion of patients who die within 30 days after randomization, assessed by hospital record or follow-up,Volume of fluid and blood product administered 4 hours after randomization Total volume (ml) of intravenous fluid and blood components recorded within 24 hours,Estimated blood loss 24 hours after randomization Estimated total blood loss (ml) from clinical evaluation, chest tube output, operative record, or imaging,Resuscitation-related complications During hospital stay Presence of arrhythmia, peripheral ischemia, acute kidney injury, mesenteric ischemia, or drug allergy diagnosed by treating physician,ICU length of stay Up to hospital discharg Number of days admitted in ICU, from medical record,Hospital length of stay Up to hospital discharge Number of days from admission to discharge | — |
Countries
Thailand
Contacts
Public ContactNatthida Owattanapanich
Faculty of Medicine Siriraj Hospital, Mahidol University
Outcome results
None listed