UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of human atrial natriuretic peptide for the patients with severe sepsis; Impact on prevention against acute kidney injury
Title of the study (Brief title)	SANP
Region	Japan

Condition
Condition	Severe sepsis
Classification by specialty	Medicine in general Nephrology Surgery in general Emergency medicine Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study examines the efficacy of human atrial natriuretic peptide (hANP) in mortality and renal function for the patients with severe sepsis.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	30-day mortality
Key secondary outcomes	Renal function Introduction of maintenance haemodialysis (HD) Ventilator free days 90-day mortality

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	The patients with severe sepsis are treated following Surviving Sepsis Campaign guidelines 2008. Patients are randomly assigned to receive hANP or distilled water (placebo) for continuous infusion. HANP is started if catecholamine index is lower than 50 and mean arterial pressure keeps more than 65 mmHg without vasopressin. HANP is administered 1000-4000 mcg per day as much as possible. In addition, hANP is administered until patients are discharged from ICU or for 14 days in ICU stay. Administration of hANP will be stopped when the adverse event is seen as follows; severe hypotension, drug allergy, anaphylaxis, severe organ failure and so on due to hANP. Severe hypotension is defined as mean arterial pressure will be less than 65mmHg and simultaneously re-administration of vasopressin will be considered. (Catecholamine index; Dopamine (mcg/kg/min) + Dobutamine (mcg/kg/min) + Noradrenaline (mcg/kg/min) * 100)
Interventions/Control_2	The patients with severe sepsis are treated following Surviving Sepsis Campaign guidelines 2008. Distilled water (placebo) is started if catecholamine index is lower than 50 and mean arterial pressure keeps more than 65 mmHg without vasopressin. In addition, distilled water is administered until patients are discharged from ICU or for 14 days in ICU stay. (Catecholamine index; Dopamine (mcg/kg/min) + Dobutamine (mcg/kg/min) + Noradrenaline (mcg/kg/min) * 100)
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	16 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	The eligibility criteria for the study are age older 16 years and the presence of severe sepsis or septic shock. Patients, who have renal failure according to RIFLE category or are dependent on mechanical ventilation including non-invasive ventilation, are enrolled. All patients are needed to have written informed consent before enrolment in the study.
Key exclusion criteria	Patients are excluded (a)if they have already introduced maintenance HD before admission, (b)have got abdominal surgery for perforation of digestive tract, (c)have fallen in sepsis for more than 48 hours before the start of antibiotic therapy, (d)can't get out of septic shock within 72 hours after the start of antibiotic therapy, (e)have severe chronic heart failure as NYHA III or IV, (f)known pregnancy, (g)expected stay in the intensive care unit of less than 3 days, or (h)poor chance of survival.
Target sample size	60

Research contact person
Name of lead principal investigator	Ryuichi Hasegawa
Organization	Tosei General Hospital
Division name	Department of Emergency and Intensive Care Medicine
Address	160 Nishioiwake-cho, Seto, Aichi, 489-8642, Japan
TEL
Email

Public contact
Name of contact person
Organization	Tosei General Hospital
Division name	Department of Emergency and Intensive Care Medicine
Address
TEL	0561-82-5101
Homepage URL
Email

Sponsor
Institute	Tosei General 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)

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	2010 Year 06 Month 24 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2010 Year 06 Month 24 Day
Anticipated trial start date	2010 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2010 Year 06 Month 24 Day
Last modified on	2018 Year 10 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004486