UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004671 |
|---|---|
| Receipt number | R000005564 |
| Scientific Title | Prospective study to examine whether Blood N-terminal proBNP (N-terminal pro brain natriuretic peptide) can be used as an indicator of cardiac preload during massive fluid resuscitation in critically ill patients. |
| Date of disclosure of the study information | 2010/12/13 |
| Last modified on | 2012/10/12 07:23:22 |
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Basic information
Public title
Prospective study to examine whether Blood N-terminal proBNP (N-terminal pro brain natriuretic peptide) can be used as an indicator of cardiac preload during massive fluid resuscitation in critically ill patients.
Acronym
Prospective study to examine blood levels of N-terminal proBNP as an indicator of cardiac preload during resusucitation.
Scientific Title
Prospective study to examine whether Blood N-terminal proBNP (N-terminal pro brain natriuretic peptide) can be used as an indicator of cardiac preload during massive fluid resuscitation in critically ill patients.
Scientific Title:Acronym
Prospective study to examine blood levels of N-terminal proBNP as an indicator of cardiac preload during resusucitation.
Region
| Japan |
Condition
Condition
shock
Classification by specialty
| Laboratory medicine | Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine if Blood N-terminal proBNP can be used as an indicator of cardiac preload during massive fluid resuscitation in critically ill patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
To evaluate the correlation between the NT-proBNP level and global end-diastolic volume index (GEDVI) measured by thermodilution method
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
NT-proBNP
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Mean Arterial Pressure ; under 65mmHg
2) Cardiac Index ; under 2.2L/min/m2
3) Patients who need IV fluid infusion more than 1,000mL in four hours
4) No gender restrictions
5) Adults over 20 years
6) Patients who had PiCCO catheter inserted to evaluatehemodynamic monitoring
7) Patients with the consent of himself, his legal representative or guardian
Key exclusion criteria
1) Systemic Vascular Resistance Index ; 1200 dynesxsec/cm5/m2
2) History of heart failure
3) Patients without the consent of himself, his legal representative or guardian
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoshi Yamanouchi |
Organization
Tohoku University School of Medicine
Division name
Emergency Medicine
Zip code
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Tohoku University School of Medicine
Division name
Emergency Medicine
Zip code
Address
TEL
Homepage URL
med-kenkyo@bureau.tohoku.ac.jp
Sponsor or person
Institute
Emergency Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2010 | Year | 12 | Month | 13 | 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
Terminated
Date of protocol fixation
| 2010 | Year | 11 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 12 | Month | 07 | Day |
Last modified on
| 2012 | Year | 10 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005564
