Tokyo, Jan. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059218) titled 'PERfusion-guided Strategic hypotensiON for AduLts In SEptic shock' on Jan. 1.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - Active

Primary Sponsor: Institute - Akira Endo, Department of Acute Critical Care and Disaster Medicine, Institute of Science Tokyo

Condition: Condition - Septic shock Classification by malignancy - Others Genomic information - NO

Objective: 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). Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - In the Permissive Hypotension group, following achievement of an initial resuscitation target of MAP 65 mmHg, the target MAP will be stepwise reduced in 5-mmHg increments as long as capillary refill time (CRT) remains below 3 seconds. To minimize the risk of inadequate organ perfusion, the lower limit of MAP will be set at 50 mmHg . Interventions/Control_2 - In the Usual Care group, MAP will be maintained at 65 mmHg in accordance with the 2021 Surviving Sepsis Campaign Guidelines.

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 Size - 230

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 08 Month 23 Day Anticipated trial start date - 2026 Year 01 Month 01 Day Last follow-up date - 2027 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067335

Disclaimer: Curated by HT Syndication.