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Optimal Target Blood Pressure in Elderly with Septic Shock trial

High versus low blood pressure target strategy in geriatric patients with septic shock; a multicenter randomized controlled trial - High versus low blood pressure target strategy in geriatric patients with septic shock;

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000041775
Enrollment
836
Registered
2020-10-01
Start date
2021-07-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Septic shock

Interventions

Targeting mean arterial pressure of 80-85 mmHg during the first 72 hours after randomization Targeting mean arterial pressure of 65-70 mmHg during the first 72 hours after randomization

Sponsors

Japanese Association for Acute Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with septic shock who are aged 65 years or older and requires management in an intensive care unit

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
All-cause mortality at 90 days after randomization

Secondary

MeasureTime frame
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

Countries

Japan

Contacts

Public ContactAkira Endo

Tokyo Medical and Dental University Trauma and Acute Critical Care Center

eraeaccm@tmd.ac.jp03-3813-6111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Sep 9, 2026