NIPH Clinical Trials Search

UMIN ID: UMIN000001059

Registered date:07/03/2008

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

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedTrauma patients with hemorrhagic shock
Date of first enrollment2007/12/01
Target sample size100
Countries of recruitmentJapan
Study typeObservational


Primary Outcome1) 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
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum16years-old
Age maximumNot applicable
GenderMale and Female
Include criteria
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


public contact
Name Akiyoshi Hagiwara
Address 3-2 Namiki, Tokorozawa, Saitama, 359-8513 Japan Japan
Telephone 04-2995-1511
Affiliation National Defense Medical College, Japan Department of Traumatology and Critical Care Medicine
scientific contact
Name Akio Kimura
Address 1-21-1 Toyama, Shinjyuku-ku, Tokyo, 162-8655 Japan Japan
Telephone 03-3202-7181
Affiliation International Medical Center of Japan, Tokyo, Japan Department of Emergency Medicine and Traumatology and Toxicology