Skip to main content
Clinical Trials/ISRCTN10580502
ISRCTN10580502
Completed
未知

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
未知
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)

Registry
who.int
Start Date
April 11, 2017
End Date
October 31, 2019
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Sponsor
Intensive Care National Audit & Research Centre

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

Similar Trials