Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ENROLLING BY INVITATION
NCT06977659
PHASE1/PHASE2

Early Norepinephrine in Trauma Patients With Hemorrhagic Shock

Sponsor: Visarat Palitnonkiat

View on ClinicalTrials.gov

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 to answer are: Does norepinephrine affect the short-term mortality (24-hour mortality)? Does norepinephrine affect the long-term mortality (30-day mortality), survival with favorable outcome, total volume of blood product and crystalloid given in 24 hours, estimated blood loss within 24 hours, resuscitation-related complications, and length of ICU and hospital stay? What medical problems do participants have when receiving norepinephrine? Researchers will compare norepinephrine to a placebo (a look-alike substance that contains no drug) to see if norepinephrine works to treat trauma patients with hemorrhagic shock. Participants will: Receive norepinephrine or a placebo intravenously within 1 hour after randomization, infused for 24 hours after randomization, and then discontinued. Patients are monitored for outcomes and adverse events.

Official title: Early Norepinephrine in Trauma Patients With Hemorrhagic Shock (ENTHeS Trial): A Randomized Open-label Clinical Trial

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2025-05-20

Completion Date

2027-08-18

Last Updated

2025-05-18

Healthy Volunteers

No

Interventions

DRUG

Norepinephrine

Norepinephrine bitartrate (LEVOPHEDR, Pfizer inc.) 4 mg/4ml + 5% Dextrose in water 246 ml (total volume 250 ml, final concentration 16 mcg/ml) infuses intravenously via a central catheter or peripheral line with the rate of 10 ml/h (equivalent to 0.05 mcg/kg/min for a 50-kg patient). The drug will be initiated within 1 hour after randomization, infused for 24 hours after randomization, and then discontinued.

DRUG

Placebo

5% Dextrose in water 250 ml infused intravenously at a rate of 10 ml/h. The drug will be initiated within 1 hour after randomization, infused for 24 hours after randomization, and then discontinued.

Locations (2)

Faculty of Medicine Ramathibodi Hospital

Bangkok, Thailand

Faculty of Medicine Siriraj Hospital

Bangkok, Thailand