UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001524
Receipt No. R000001838
Scientific Title Efficacy of Low-Dose Continuous Infusion of Human Atrial Natriuretic Peptide (hANP) During Lung Resection Surgery
Date of disclosure of the study information 2009/07/05
Last modified on 2012/06/06

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Efficacy of Low-Dose Continuous Infusion of Human Atrial Natriuretic Peptide (hANP) During Lung Resection Surgery
Acronym Efficacy of hANP During Lung Resection Surgery
Scientific Title Efficacy of Low-Dose Continuous Infusion of Human Atrial Natriuretic Peptide (hANP) During Lung Resection Surgery
Scientific Title:Acronym Efficacy of hANP During Lung Resection Surgery
Region
Japan

Condition
Condition Lung Resection Surgery
Classification by specialty
Chest surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of hANP during lung resection surgery
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase II,III

Assessment
Primary outcomes whether infusion of hANP during pulmonary resection has an effect on the reduction of postoperative complications (atrial fibrillation)
Key secondary outcomes Postoperative hemodynamics, white blood cell counts, and C-reactive protein levels

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Low-dose continuous infusion of hANP group
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who undergo pulmonary resections and preoperative BNP of 30pg/mL or more
Key exclusion criteria None
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Nojiri
Organization Toneyama National Hospital
Division name General Thoracic Surgery
Zip code
Address Toneyama 5-1-1,Toyonaka City, Osaka 560-8552,Japan
TEL 06-6853-2001
Email

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Nojiri
Organization Toneyama National Hospital
Division name General Thoracic Surgery
Zip code
Address Toneyama 5-1-1,Toyonaka City, Osaka 560-8552,Japan
TEL 06-6853-2001
Homepage URL
Email honnnori2003@yahoo.co.jp

Sponsor
Institute Toneyama National Hospital
Institute
Department

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 07 Month 05 Day

Related information
URL releasing protocol http://www.hosp.go.jp/toneyama/
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/21992849
Number of participants that the trial has enrolled
Results
Continuous infusion of low-dose human atrial natriuretic peptide during lung cancer surgery had a prophylactic effect against postoperative atrial fibrillation after pulmonary resection in patients with preoperative elevation of B-type natriuretic peptide levels. 
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
2008 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2008 Year 04 Month 01 Day
Last follow-up date
2009 Year 04 Month 01 Day
Date of closure to data entry
2009 Year 04 Month 01 Day
Date trial data considered complete
2009 Year 06 Month 01 Day
Date analysis concluded
2009 Year 10 Month 01 Day

Other
Other related information

Management information
Registered date
2008 Year 11 Month 23 Day
Last modified on
2012 Year 06 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001838

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.