UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Influence of continuous infusion of low-dose human atrial natriuretic peptide on renal function during cardiac surgery
Title of the study (Brief title)	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	Akira Sezai
Organization	Nihon University School of Medicine
Division name	Department of Cardiovascular Surgery
Address	30-1 Oyaguchi kami-machi, Itabashi-ku, Tokyo, Japan
TEL	03-3972-8111
Email	asezai.med@gmail.com

Public contact
Name of contact person	Akira Sezai
Organization	Nihon University School of Medicine
Division name	Department of Cardiovascular Surgery
Address	30-1 Oyaguchi kami-machi, Itabashi-ku, Tokyo, Japan
TEL	03-3972-8111
Homepage URL
Email	asezai.med@gmail.com

Sponsor
Institute	Nihon University School of Medicine
Institute
Department

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.

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

Progress
Recruitment status	Completed
Date of protocol fixation	1997 Year 03 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001749