UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002905 |
|---|---|
| Receipt number | R000003542 |
| Scientific Title | Effects of Vasodilators on Renal Function and Neuroholmonal Activation in Patients With Acute Pulmonary Edema |
| Date of disclosure of the study information | 2009/12/16 |
| Last modified on | 2011/12/17 08:57:54 |
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Basic information
Public title
Effects of Vasodilators on Renal Function and Neuroholmonal Activation in Patients With Acute Pulmonary Edema
Acronym
Effects of Vasodilators on Renal Function and Neuroholmonal Activation in Patients With Acute Pulmonary Edema
Scientific Title
Effects of Vasodilators on Renal Function and Neuroholmonal Activation in Patients With Acute Pulmonary Edema
Scientific Title:Acronym
Effects of Vasodilators on Renal Function and Neuroholmonal Activation in Patients With Acute Pulmonary Edema
Region
| Japan |
Condition
Condition
Acute Cardiogenic Pulmonary Edema
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the imapct of intravenous vasodilators(carperitide or isosorbide dinitrate) on renal function and neuroholmonal activations in patients with acute cardiogenic pulmonary edema
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in serum creatinine, BUN and cystatin C levels from the admission value to discharge and/or day 7 of hospitalization
Key secondary outcomes
Change in serum neuroholmonal factor (catecholamine, renin, angiotensin II, aldosterone and vasopressin) levels before and at 15, 30, 60, and 180 minutes after administration of vasodilators
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Continuous infusion of carperitide at 0.025 microg/kg/min for 72 hours
Interventions/Control_2
Continuous infusion of isosorbide dinitrate (ISDN) at 0.5 microg/kg/min for 72 hours
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)Pulmonary edema on admission
2)Dyspnea as a chief compliant
3)Systolic blood pressure >100mmHg
4)Patients providing written consent for participation in this clinical trial on their own volition after receiving a thorough explanation of the study
Key exclusion criteria
1)Systolic blood pressure <100mmHg
2)Patients on hemodialysis
3)Patients with acute coronary syndrome
4)Patients with a history of hypersensitivity to any of the components of the product
5)Patients who are judged by the principal investigator to be ineligible for enrollment in the study
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tohru Masuyama |
Organization
Hyogo College of Medicine
Division name
Cardiovascular Division
Zip code
Address
1-1 Mukogawa-cho, Nishinomiya-city, Hyogo 6638501 JAPAN
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenichi Fujii |
Organization
Hyogo College of Medicine
Division name
Cardiovascular Division
Zip code
Address
1-1 Mukogawa-cho, Nishinomiya-city, Hyogo 6638501 JAPAN
TEL
0798-45-6553
Homepage URL
Sponsor or person
Institute
Cardiovascular Division, Hyogo College of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
| 2009 | Year | 12 | Month | 16 | 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
| 2009 | Year | 11 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 12 | Month | 16 | Day |
Last modified on
| 2011 | Year | 12 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003542
