UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059218 |
|---|---|
| Receipt number | R000067335 |
| Scientific Title | PERfusion-guided Strategic hypotensiON for AduLts In SEptic shock: A multicentre randomised clinical trial |
| Date of disclosure of the study information | 2026/01/01 |
| Last modified on | 2026/01/22 17:32:58 |
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Basic information
Public title
PERfusion-guided Strategic hypotensiON for AduLts In SEptic shock
Acronym
PERSONALISE trial
Scientific Title
PERfusion-guided Strategic hypotensiON for AduLts In SEptic shock: A multicentre randomised clinical trial
Scientific Title:Acronym
PERSONALISE trial
Region
| Japan |
Condition
Condition
Septic shock
Classification by specialty
| Infectious disease | Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This clinical trial aims to evaluate the efficacy and safety of the hypothesis that, in patients with septic shock undergoing initial resuscitation, a permissive hypotension strategy (allowing lower mean arterial pressure (MAP) as long as peripheral tissue perfusion is adequately maintained) will provide greater clinical benefit compared with usual care (MAP is targeted at 65 mmHg in accordance with the Surviving Sepsis Campaign Guideline 2021). In addition, we will evaluate whether the timing of vasopressin initiation modifies the effect of a CRT-guided individualized permissive hypotension strategy, and will exploratorily examine the effects for clinical outcomes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Catecholamine-free days at 28 days
Key secondary outcomes
1. Ischemia-related adverse events within 72 hours after randomization (myocardial infarction, ischemic stroke, intestinal necrosis, or irreversible peripheral limb ischemia).
2. Arrhythmias within 72 hours after randomization (ventricular tachycardia or supraventricular arrhythmias with hemodynamic compromise).
3. Hemorrhagic events within 72 hours after randomization.
4. All-cause mortality at 28 and 90 days after randomization.
5. Lactate clearance at 24 hours after randomization.
6. SOFA score at 72 hours after randomization.
7. Ventilator-free days at 28 days.
8. Renal replacement therapy-free days at 28 days.
9. KDIGO criteria at 28 days or at hospital discharge
10. Win ratio, defined in the following hierarchical order: (i)90-day mortality, (ii) ventilator days, (iii) renal replacement therapy days, and (iv) vasopressor days.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is 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
4
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
In the permissive hypotension group, after achieving an initial MAP of 65 mmHg during early resuscitation, the target MAP will be gradually reduced in 5-mmHg increments, as long as a capillary refill time (CRT) of <3 seconds is maintained. To minimize the risk of potential organ hypoperfusion, the lower limit of the target MAP will be set at >=50 mmHg. Vasopressin will be initiated in combination when a norepinephrine dose of >=0.1 ug/kg/min is required.
Interventions/Control_2
In the Usual Care group, MAP will be maintained at 65 mmHg in accordance with the 2021 Surviving Sepsis Campaign Guidelines.
Vasopressin will be initiated in combination when a norepinephrine dose of >=0.1 ug/kg/min is required.
Interventions/Control_3
In the permissive hypotension group, after achieving an initial MAP of 65 mmHg during early resuscitation, the target MAP will be gradually reduced in 5-mmHg increments, as long as a capillary refill time (CRT) of <3 seconds is maintained. To minimize the risk of potential organ hypoperfusion, the lower limit of the target MAP will be set at >=50 mmHg. Vasopressin will be initiated in combination when a norepinephrine dose of >=0.3 ug/kg/min is required.
Interventions/Control_4
In the Usual Care group, MAP will be maintained at 65 mmHg in accordance with the 2021 Surviving Sepsis Campaign Guidelines.
Vasopressin will be initiated in combination when a norepinephrine dose of >=0.3 ug/kg/min is required.
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Individuals who meet all the following criteria:
1. Patients who are aged 18 years or older
2. Patients who are diagnosed with septic shock clinically (irrespective of out-of-hospital or in-hospital onset)
3. Patients who admitted to intensive care unit.
Key exclusion criteria
Individuals who met either of the following criteria:
1. Patients who have been on vasopressors for 3 or more hours
2. Patients who have the advanced directives restricting implementation of the standard critical care (e.g., catecholamine use, mechanical ventilation, and renal replacement therapy)
3. Patients experiencing cardiac arrest before randomization
4. Patients with other diseases that require stricter blood pressure control than for maintaining hemodynamics in septic shock
5. Patients who need to be arrested, detained, or put in custody by law enforcement or legal agencies
6. Patients who refuse to participate in the trial
7. Patient who is ultimately unable to provide consent, either by themselves or through a legally authorized representative
8. Patients deemed ineligible to participate by a clinical physician
Target sample size
232
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Endo |
Organization
Institute of Science Tokyo
Division name
Department of Acute Critical Care and Disaster Medicine
Zip code
113-8519
Address
1-5-45 Yushima, Bunkyo, Tokyo
TEL
03-3813-6111
akira.endo.0112@gmail.com
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Endo |
Organization
Institute of Science Tokyo
Division name
Department of Acute Critical Care and Disaster Medicine
Zip code
113-8519
Address
1-5-45 Yushima, Bunkyo, Tokyo
TEL
03-3813-6111
Homepage URL
akira.endo.0112@gmail.com
Sponsor or person
Institute
Akira Endo, Department of Acute Critical Care and Disaster Medicine, Institute of Science Tokyo
Institute
Department
Personal name
Funding Source
Organization
Japanese Association for Acute Medicine
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 Ethics Committee of Institute of Science Tokyo
Address
1-5-45 Yushima, Bunkyo, Tokyo
Tel
03-5803-4574
mkan-rinsho.adm@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
1. 東京科学大学病院（東京都）
2. 大阪医科薬科大学病院（大阪府）
3. 東京慈恵会医科大学附属病院（東京都）
4. 大阪急性期・総合医療センター（大阪府）
5. 総合病院土浦協同病院（茨城県）
6. 慶應義塾大学病院（東京都）
7. 兵庫県立西宮病院（兵庫県）
8. 札幌医科大学病院（北海道）
9. 亀田総合病院（千葉県）
10. 静岡県立総合病院（静岡県）
11. 北海道大学病院（北海道）
12. 筑波大学附属病院（茨城県）
13. 山口大学医学部附属病院（山口県）
14. 東京女子医科大学足立医療センター（東京都）
15. 海老名総合病院（神奈川県）
16. 埼玉医大国際医療センター（埼玉県）
17. 川﨑医科大学附属病院（岡山県）
18. 宮崎県立宮崎病院（宮崎県）
19. 横浜市立大学附属病院（神奈川県）
20. 大阪府立中河内救命救急センター（大阪府）
21. 大分大学医学部附属病院（大分県）
22. 東海大学医学部附属病院（神奈川県）
23. 佐賀大学医学部附属病院（佐賀県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | 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
| 2025 | Year | 08 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2027 | 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
| 2025 | Year | 09 | Month | 28 | Day |
Last modified on
| 2026 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067335
