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


Email



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


Email



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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name