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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000041775 |
Receipt No. | 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 | 2021/03/15 |
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 |
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Condition | |||
Condition | Septic shock | ||
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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Target sample size | 832 |
Research contact person | |||||||
Name of lead principal investigator |
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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 | ||||||
otomo.accm@tmd.ac.jp |
Public contact | |||||||
Name of contact person |
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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 | |
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 |
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 |
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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 |
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Anticipated trial start date |
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Last follow-up date |
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Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |