Hypotension Circulatory System Hypotension
Conditions
Interventions
Current intervention as of 20/03/2019:
Patients will be randomised following a 1:1 sequence to either the intervention group (permissive hypotension) or usual care.
Permissive hypotension group: Pat
Sponsors
Intensive Care National Audit & Research Centre
Eligibility
Sex/Gender
All
Inclusion 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 4. Vasopressors expected to continue for 6 hours or more as assessed by treating clinician
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical evaluation: All-cause mortality is assessed through data-linkage with nationally held death registrations at 90 days. Economic evaluation: Incremental net monetary benefit (INB), evaluated at the NICE recommended threshold of £20,000 per quality-adjusted life year (QALY), at 90 days. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Mortality at discharge from the critical care unit and acute hospital is assessed by reviewing patient medical notes at critical care unit discharge 2. Duration of survival is assessed through data-linkage with nationally held death registrations at the longest available follow-up (e.g. patients will be followed up for a minimum of six months following randomisation, with the earliest recruited patients followed-up for survival to 24 months) 3. Duration of advanced respiratory and renal support (defined according to the Critical Care Minimum Dataset [CCMDS]) during the critical care unit stay is assessed by reviewing patient medical notes at critical care unit discharge 4. Days alive and free of advanced respiratory support and renal support is assessed by reviewing patient medical notes at critical care unit discharge 5. Duration of critical care unit and acute hospital stay is assessed by reviewing patient medical notes at critical care unit and hospital discharge 6. Cognitive function is assessed using the Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE, short version) at 90 days and one year 7. Health-related quality of life is assessed using the EuroQol EQ-5D-5L questionnaire at 90 days and one year 8. Resource use and costs is assessed using a health services questionnaire at 90 days and one year 9. Estimated lifetime incremental cost-effectiveness | — |
Countries
England, United Kingdom
Contacts
Public ContactAlvin Richards-Belle
Outcome results
None listed