UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041775 |
|---|---|
| Receipt number | R000047681 |
| Scientific Title | High versus low blood pressure target strategy in geriatric patients with septic shock; a multicenter randomized controlled trial |
| Date of disclosure of the study information | 2020/10/01 |
| Last modified on | 2025/05/15 13:29:01 |
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Basic information
Public title
Optimal Target Blood Pressure in Elderly with Septic Shock trial
Acronym
OPTPRESS trial
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 highly likely to be transferred to another hospital within 72 h of randomisation
2. Patients who have been on vasopressors for 3 or more hours
3. Patients experiencing cardiac arrest before randomisation
4. Patients who are diagnosed with coronavirus disease 2019
5. Patients who have the advanced directives restricting implementation of the standard critical care (e.g., catecholamine use, mechanical ventilation, and renal replacement therapy)
6. Patients with other diseases that require stricter blood pressure control than for maintaining haemodynamics in septic shock (uncontrollable active bleeding, aneurysms, arterial dissection, etc.)
7. Patients participating in other clinical trials that involve interventions
8. Patients who need to be arrested, detained, or put in custody by law enforcement or legal agencies
9. Patients who refuse to participate in the trial
10. Patients deemed ineligible to participate by a clinical physician.
Target sample size
836
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Endo |
Organization
Tokyo Medical and Dental University
Division name
Department of Acute Critical Care and Disaster Medicine, Graduate School of Medical and Dental Sciences
Zip code
113-8510
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-3813-6111
eraeaccm@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
eraeaccm@tmd.ac.jp
Sponsor or person
Institute
Japanese Association for Acute Medicine
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research from Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
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
https://pmc.ncbi.nlm.nih.gov/articles/PMC9509562/
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s00134-025-07910-4
Number of participants that the trial has enrolled
518
Results
Of the 518 patients, 258 were in the high-target group, and 260 were in the control group. By 90 days after randomisation, 101 patients (39.3%) in the high-target group and 74 (28.6%) in the control group had died from any cause (risk difference = 10.7; 95% confidence interval, 2.6-18.9). Renal replacement therapy-free days at 28 days were shorter in the high-target group. No clinical benefits for any outcome were observed in any subpopulation, including those with known chronic hypertension.
Results date posted
| 2025 | Year | 05 | Month | 15 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Table 1, Table E1 of the article (available at: https://link.springer.com/article/10.1007/s00134-025-07910-4)
Participant flow
Figure 1 of the article (available at: https://link.springer.com/article/10.1007/s00134-025-07910-4)
Adverse events
Results section of the article (available at: https://link.springer.com/article/10.1007/s00134-025-07910-4)
Outcome measures
Results section of the article (available at: https://link.springer.com/article/10.1007/s00134-025-07910-4)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 09 | Month | 12 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 06 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 13 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 15 | Day |
Date trial data considered complete
| 2024 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2024 | Year | 04 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 09 | Month | 13 | Day |
Last modified on
| 2025 | Year | 05 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047681
