UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of intravenous immunoglobulin replacement therapy for hypogammaglobulinemia in severe infections
Title of the study (Brief title)	Efficacy of intravenous immunoglobulin replacement therapy for hypogammaglobulinemia in severe infections
Region	Japan

Condition
Condition	severe infectious diseases
Classification by specialty	Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To reveal the patient's characteristics and the improvement of their prognosis by administrating IVIG
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	prognosis (ICU mortality rate, 28 days mortality rate, 90-days mortality rate, hospital mortality rate)
Key secondary outcomes	1) characteristics of the patients 2) the severity of organ failure: SOFA score JAAM-DIC score 3) Serum IgG value and IVIG dosage at admitting to the ICU 4) Evaluation of reactivity to the treatment: Changes in SOFA score, Days of vasopressors, Length of ICU days, Hospitalized Days, ventilator days

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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 patients admitted to the ICU during the study period
Key exclusion criteria	1) A case of death or survival within 24 hours after admitting to the ICU 2) Child under 15 years old
Target sample size	300

Research contact person
Name of lead principal investigator	Hiroomi Tatsumi
Organization	Sapporo Medical University School of Medicine
Division name	Department of Intensive Care Medicine
Address	South1 West16, Chuo-ku, Sapporo
TEL	011-611-2111
Email	tatsumi@qc4.so-net.ne.jp

Public contact
Name of contact person	Masayuki Akatsuka
Organization	Sapporo Medical University School of Medicine
Division name	Department of Intensive Care Medicine
Address	South1 West16, Chuo-ku, Sapporo
TEL	011-611-2111
Homepage URL
Email	m_a_let_go@yahoo.co.jp

Sponsor
Institute	Sapporo Medical University
Institute
Department

Funding Source
Organization	Sapporo Medical University
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	2018 Year 06 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 02 Month 01 Day
Anticipated trial start date	2018 Year 03 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	We will analyze the efficacy of intravenous immunoglobulin replacement therapy by collecting data in the future.

Management information
Registered date	2018 Year 05 Month 31 Day
Last modified on	2018 Year 05 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037406