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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001059
Receipt No. R000001285
Scientific Title A prospective, multicentre, observational trial for hemodynamic reaction following initial fluid resuscitation in patients with hemorrhagic shock due to blunt trauma
Date of disclosure of the study information 2008/03/07
Last modified on 2008/08/08

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Basic information
Public title A prospective, multicentre, observational trial for hemodynamic reaction following initial fluid resuscitation in patients with hemorrhagic shock due to blunt trauma
Acronym Hemodynamic reaction following initial fluid resuscitation in patients with hemorrhagic shock
Scientific Title A prospective, multicentre, observational trial for hemodynamic reaction following initial fluid resuscitation in patients with hemorrhagic shock due to blunt trauma
Scientific Title:Acronym Hemodynamic reaction following initial fluid resuscitation in patients with hemorrhagic shock
Region
Japan

Condition
Condition Trauma patients with hemorrhagic shock
Classification by specialty
Emergency medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Japan Advanced Trauma Evaluation and Care (JATEC) and Advanced Trauma Life Support (ATLS) suggest that, in patients with hemorrhagic shock, the response and the treatment policy for initial fluid resuscitation should be categorized into three groups: 1) responder; 2) transient responder; and 3) non-responder. Hemorrhagic shock is comprehensively diagnosed based on several clinical findings, such as skin color, pulse rate, blood pressure, consciousness levels, etc. However, the diagnosis varies depending on clinical experiences of each physician and/or each ER system. For clinically investigating hemorrhagic shock, an evidence-based objective index for the shock is necessary. Research results and scientific literature that have been reported in the past used systolic blood pressure (SBP) and HR as standard criteria for evaluation of the shock. However, the rationale for setting BP and HR for criteria of the categorization of hemorrhagic shock, still remain uncertain.
This study aims to 1) define (levels of) hemorrhagic shock using BP, HR, and transfused volume, and 2) determine treatment policy based on response to initial fluid resuscitation using the results of 1), and 3) determine whether the coagulation function and lactic acid value at admission can be used to categorize the shock into responder, transient responder, or non-responder.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 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 secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1) Patients who received initial fluid resuscitation for hemorrhagic shock
(2) Patients with physiological abnormality (Step 1), anatomical abnormality (Step 2), or mechanism of injury (high-energy injuries: Step 3) defined by JATEC (guideline p233).
Patients who meet criteria for 1 or 2 above.

Key exclusion 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)

Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akio Kimura
Organization International Medical Center of Japan, Tokyo, Japan
Division name Department of Emergency Medicine and Traumatology and Toxicology
Zip code
Address 1-21-1 Toyama, Shinjyuku-ku, Tokyo, 162-8655 Japan
TEL 03-3202-7181
Email

Public contact
Name of contact person
1st name
Middle name
Last name Akiyoshi Hagiwara
Organization National Defense Medical College, Japan
Division name Department of Traumatology and Critical Care Medicine
Zip code
Address 3-2 Namiki, Tokorozawa, Saitama, 359-8513 Japan
TEL 04-2995-1511
Homepage URL
Email boeihagi@ndmc.ac.jp

Sponsor
Institute The General Planning Committee of Japanese Association for the Surgery of Trauma
Institute
Department

Funding Source
Organization The Japanese Association for the Surgery of Trauma
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2008 Year 03 Month 07 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2007 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2007 Year 12 Month 01 Day
Last follow-up date
2008 Year 07 Month 01 Day
Date of closure to data entry
2008 Year 08 Month 01 Day
Date trial data considered complete
2008 Year 08 Month 01 Day
Date analysis concluded
2008 Year 12 Month 01 Day

Other
Other related information A prospective, multicentre, observational trial

Management information
Registered date
2008 Year 02 Month 29 Day
Last modified on
2008 Year 08 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001285

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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