ISRCTN10580502
Completed
N/A
Evaluating the clinical and cost-effectiveness of permissive hypotension in critically ill patients aged 65 years or over with vasodilatory hypotension
Intensive Care National Audit & Research Centre0 sites2,600 target enrollmentApril 11, 2017
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Intensive Care National Audit & Research Centre
- Enrollment
- 2600
- Status
- Completed
- Last Updated
- last year
Overview
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)
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
Not specified
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