A prospective, multicentre, observational trial for hemodynamic reaction following initial fluid resuscitation in patients with hemorrhagic shock due to blunt trauma

UMIN ID: UMIN000001059

Registered date:07/03/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Trauma patients with hemorrhagic shock
• Date of first enrollment: 2007/12/01
• Target sample size: 100
• Countries of recruitment: Japan
• Study type: Observational

Outcome(s)

• Primary Outcome: 1) Character of patients with hemorrhagic shock 2) Systolic blood pressure (SBP) and heart rate (HR) on admission 3) SBP and HR at the time when 1L of fluid replacement was administered. 4) SBP and HR at the time when 2L was administered. 5) SBP and HR at the time when the management of ER was finished. 6) Total volume of fluid replacement and blood transfusion at ER 7) Total volume of fluid replacement and blood transfusion during 24 hr 8) Details of interventional treatment performed for hemorrhage

Key inclusion & exclusion criteria

• Age minimum: 16years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: (1) Penetrating trauma (2) When the physician selected permissive hypotension therapy (3) Cardiopulmonary arrest (4) Patients whose fluid therapy started before admission (5) Patients with terminal stage of chronic disease (6) When the physician consider that the initial fluid resuscitation therapy is inappropriate for the patient (state the specific reason)

Related Information

• Primary Sponsor: The General Planning Committee of Japanese Association for the Surgery of Trauma
• Source(s) of Monetary Support: The Japanese Association for the Surgery of Trauma