UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001440 |
|---|---|
| Receipt number | R000001749 |
| Scientific Title | Influence of continuous infusion of low-dose human atrial natriuretic peptide on renal function during cardiac surgery |
| Date of disclosure of the study information | 2008/10/20 |
| Last modified on | 2018/03/26 11:08:30 |
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Basic information
Public title
Influence of continuous infusion of low-dose human atrial natriuretic peptide on renal function during cardiac surgery
Acronym
Influence of human atrial natriuretic peptide on renal function during cardiac surgery
Scientific Title
Influence of continuous infusion of low-dose human atrial natriuretic peptide on renal function during cardiac surgery
Scientific Title:Acronym
Influence of human atrial natriuretic peptide on renal function during cardiac surgery
Region
| Japan |
Condition
Condition
myocardial infarction, angina, valvular disease, thoracic aortic aneurysm
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Acute renal failure occurs after cardiac surgery in 2.4-16% of patients who have normal renal function preoperatively, and the prognosis of such patients is relatively poor with a mortality rate of 1.3-30%. The mortality rate rises to 33-63.7% in patients requiring hemodialysis.
Human atrial natriuretic peptide (hANP) is a hormone that is secreted in response to stretching of the atrial wall. It has a vasodilatory effect, a potent natriuretic effect, suppresses the renin-angiotensin-aldosterone system (RASS), and causes coronary artery dilation, and has thus been used clinically as a new drug for the treatment of cardiac failure.
we conducted the effect of hANP infusion during CPB on postoperative renal function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
mortality
complication
Incidence of postoperative acute renal failure
maximum value and percent increase of Cr.
Key secondary outcomes
pre-op, 0,1,3,7 days after surgery: ANP, renin activity, angiotensin II, aldosterone, blood urea nitrogen (BUN), Cr, sodium (Na), osmotic pressure (Osm),Urinary Na (U-Na), urinary Cr (U-Cr), and osmotic pressure (U-osm) .
pre-op, 0,1,3,7 days after surgery: creatinine clearance Ccr, fractional sodium excretion, free water clearance and renal failure index.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Perioperative administration of hANP
Interventions/Control_2
Perioperative non-administration of hANP
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
Patient undergoing cardiac surgery
Patients from whom informed consent was obtained
Key exclusion criteria
renal impairment(Cr>1.3mg/dl)
cardiogenic shock
Target sample size
700
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akira Sezai |
Organization
Nihon University School of Medicine
Division name
Department of Cardiovascular Surgery
Zip code
Address
30-1 Oyaguchi kami-machi, Itabashi-ku, Tokyo, Japan
TEL
03-3972-8111
asezai.med@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akira Sezai |
Organization
Nihon University School of Medicine
Division name
Department of Cardiovascular Surgery
Zip code
Address
30-1 Oyaguchi kami-machi, Itabashi-ku, Tokyo, Japan
TEL
03-3972-8111
Homepage URL
asezai.med@gmail.com
Sponsor or person
Institute
Nihon University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
a grant for the 60th anniversary of the Alumni Association of Nihon University School of Medicine and for the 50th anniversary of the foundation of Nihon University School of Medicine.
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
| 2008 | Year | 10 | Month | 20 | 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
| 1997 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 1997 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2010 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2010 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 10 | Month | 20 | Day |
Last modified on
| 2018 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001749
