UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003631 |
|---|---|
| Receipt number | R000004402 |
| Scientific Title | Clinical Research; Efficacy of human natriuretic atrial peptide (hANP) on lung resection surgery Basic Research; Efficacy of hANP on pulmonary disease |
| Date of disclosure of the study information | 2010/05/18 |
| Last modified on | 2012/06/06 16:44:16 |
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Basic information
Public title
Clinical Research; Efficacy of human natriuretic atrial peptide (hANP) on lung resection surgery
Basic Research; Efficacy of hANP on pulmonary disease
Acronym
hANP study of pulmonary disease
Scientific Title
Clinical Research; Efficacy of human natriuretic atrial peptide (hANP) on lung resection surgery
Basic Research; Efficacy of hANP on pulmonary disease
Scientific Title:Acronym
hANP study of pulmonary disease
Region
| Japan |
Condition
Condition
Pulmonary disease
Classification by specialty
| Pneumology | Chest surgery |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The objective of this study is to evaluate the efficacy of hANP on pulmonary disease.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
1. The incidence of postoperative complications after lung resection surgery
Key secondary outcomes
1. Postoperative hemodynamics
2. Postoperative inflammatory change ( white blood cell counts and C-reactive protein levels)
3. Postoperative creatinine levels and glomerular filtration rate
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Group of hANP treatment
Interventions/Control_2
Control group
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
All patients undergoing pulmonary resection in our hospital
Key exclusion criteria
None
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Nojiri |
Organization
Osaka University Graduate School of Medicine
Division name
General Thoracic Surgery
Zip code
Address
2-2 (L5), Yamadaoka, Suita-city, Osaka 565-0871, Japan
TEL
81-6-6879-3152
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Nojiri |
Organization
National Cerebral and Cardiovascular Center
Division name
Biochemistry
Zip code
Address
5-7-1, Fujishirodai, Suita-city, Osaka 565-8565
TEL
81-6-6833-5012
Homepage URL
nojirit@thoracic.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Graduate School of Medicine, Department of General Thoracic Surgery
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
National Cerebral and Cardiovascular Center
National Toneyama Hospital
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
大阪大学附属病院（大阪府）
国立循環器病研究センター（大阪府）
国立病院機構刀根山病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 05 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
http://www.ncbi.nlm.nih.gov/pubmed/22290883
Number of participants that the trial has enrolled
Results
RESULTS:
The incidence of post-operative cardiopulmonary complications was significantly lower in the hANP group than that in the control group. Patients in the hANP group showed significantly lower WBC counts and serum CRP levels post-operatively.
CONCLUSIONS:
Continuous infusion of low-dose hANP during lung cancer surgery had a prophylactic effect on post-operative cardiopulmonary complications in elderly lung cancer patients.
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
Open public recruiting
Date of protocol fixation
| 2006 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2017 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2017 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2017 | Year | 07 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 05 | Month | 18 | Day |
Last modified on
| 2012 | Year | 06 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004402
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
