The 65 trial

Not Applicable

Completed

• Conditions: Hypotension; Circulatory System

• Registration Number: ISRCTN10580502
• Lead Sponsor: Intensive Care National Audit & Research Centre

Brief Summary

2019 Protocol article in https://doi.org/10.1177/1751143719870088 (added 13/09/2019) 2020 Results article in https://www.ncbi.nlm.nih.gov/pubmed/32049269 (added 13/02/2020) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33648623/ (added 03/03/2021) 2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/34093727/ (added 03/05/2024)

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-11
• Study Completion: 2019-10-31
• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 2600

Inclusion Criteria

Current inclusion criteria as of 16/02/2018:
1. Age 65 years or older
2. Vasodilatory hypotension as assessed by treating clinician
3. Started infusion (for at least one hour) of vasopressors within prior 6 hours (if noradrenaline, then a minimum dose of 0.1 µg kg-1 min-1)
4. Adequate fluid resuscitation is completed or ongoing
5. Vasopressors expected to continue for 6 hours or more as assessed by treating clinician

Previous inclusion criteria:
1. Age 65 years or older
2. Vasodilatory hypotension as assessed by treating clinician
3. Decision to start vasopressors or started within prior 6 hours following/during adequate fluid resuscitation
4. Vasopressors expected to continue for 6 hours or more as assessed by treating clinician

Exclusion Criteria

1. Vasopressors being used solely as therapy for bleeding, acute ventricular failure (left or right) or post-cardiopulmonary bypass vasoplegia
2. Ongoing treatment for brain injury or spinal cord injury
3. Death perceived as imminent
4. Previous enrolment to the 65 Trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified