UMIN-CTR Clinical Trial

Public title

Efficacy of human atrial natriuretic peptide for the patients with severe sepsis; Impact on prevention against acute kidney injury

Acronym

SANP

Scientific Title

Efficacy of human atrial natriuretic peptide for the patients with severe sepsis; Impact on prevention against acute kidney injury

Scientific Title:Acronym

SANP

Region

Japan

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

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

Primary outcomes

30-day mortality

Key secondary outcomes

Renal function
Introduction of maintenance haemodialysis (HD)
Ventilator free days
90-day mortality

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Ryuichi Hasegawa

Organization

Tosei General Hospital

Division name

Department of Emergency and Intensive Care Medicine

Zip code

Address

160 Nishioiwake-cho, Seto, Aichi, 489-8642, Japan

TEL

Email

Name of contact person

1st name
Middle name
Last name

Organization

Tosei General Hospital

Division name

Department of Emergency and Intensive Care Medicine

Zip code

Address

TEL

0561-82-5101

Homepage URL

Email

Institute

Tosei General Hospital

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2010

Year

06

Month

24

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Terminated

Date of protocol fixation

2010

Year

06

Month

24

Day

Date of IRB

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

Other related information

Registered date

2010

Year

06

Month

24

Day

Last modified on

2018

Year

10

Month

12

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004486