UMIN-CTR Clinical Trial

Basic information
Public title	High versus low blood pressure target strategy in geriatric patients with septic shock; a multicenter randomized controlled trial
Acronym	High versus low blood pressure target strategy in geriatric patients with septic shock
Scientific Title	High versus low blood pressure target strategy in geriatric patients with septic shock; a multicenter randomized controlled trial
Scientific Title:Acronym	High versus low blood pressure target strategy in geriatric patients with septic shock
Region	Japan

Condition
Condition	Septic shock
Classification by specialty	Emergency medicine Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the survival outcome between high (80-85 mmHg) and low (65-70 mmHg) blood pressure target strategies in the initial resuscitation of septic shock in patients who are aged 65 years or older, using the norepinephrine dose-restricted protocol
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	All-cause mortality at 90 days after randomization
Key secondary outcomes	1. Lactate clearance at 24 hours after randomization 2. Incidence rates of adverse events (arrhythmia, thrombosis, ischemia, or hemorrhage) during the 72 hours after randomization 3. All-cause mortality rate at 28 days 4. Sepsis-related mortality at 28 days after randomization 5. Ventilator-free days at 28 days after randomization 6. Renal replacement therapy-free days at 28 days after randomization 7. Catecholamine-free days at 28 days after randomization 8. Sepsis-related mortality at 90 days after randomization

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Targeting mean arterial pressure of 80-85 mmHg during the first 72 hours after randomization
Interventions/Control_2	Targeting mean arterial pressure of 65-70 mmHg during the first 72 hours after randomization
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	65 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with septic shock who are aged 65 years or older and requires management in an intensive care unit
Key exclusion criteria	1. Patients who are transferred to another hospital within 72 hours after randomization 2. Patients who are transferred from another hospital and more than 3 hours have passed since the start of vasopressors. 3. Patients who have already participated in another trial with intervention 4. Patients who are determined to discontinue the aggressive treatment during the initial evaluation 5. Patients who have experienced cardiac arrest before randomization 6. Patients who have another disease requiring stricter blood pressure control than septic shock 7. Prisoner 8. Patients who refuse to participate in this study
Target sample size	832

Research contact person
Name of lead principal investigator	1st name Yasuhiro Middle name Last name Otomo
Organization	Tokyo Medical and Dental University
Division name	Trauma and Acute Critical Care Center
Zip code	113-8510
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL	03-3813-6111
Email	otomo.accm@tmd.ac.jp

Public contact
Name of contact person	1st name Akira Middle name Last name Endo
Organization	Tokyo Medical and Dental University
Division name	Trauma and Acute Critical Care Center
Zip code	113-8510
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL	03-3813-6111
Homepage URL
Email	eraeaccm@tmd.ac.jp

Sponsor
Institute	Japanese Association for Acute Medicine
Institute
Department

Funding Source
Organization	Self-funding
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Medical Research Institute Tokyo Medical and Dental University
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
Tel	03-3813-6111
Email	info.bec@tmd.ac.jp

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	2020 Year 10 Month 01 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	Preinitiation
Date of protocol fixation	2020 Year 09 Month 12 Day
Date of IRB
Anticipated trial start date	2021 Year 05 Month 01 Day
Last follow-up date	2024 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 09 Month 13 Day
Last modified on	2020 Year 09 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047681

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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