The 65 Trial (v1.0)
Research type
Research Study
Full title
Evaluating the clinical and cost-effectiveness of permissive hypotension in critically ill patients aged 65 years or over with vasodilatory hypotension
IRAS ID
215503
Contact name
Paul Mouncey
Contact email
Sponsor organisation
Intensive Care National Audit & Research Centre (ICNARC)
Duration of Study in the UK
2 years, 8 months, 1 days
Research summary
The optimal blood pressure target to guide treatment in critical care is not known. It is, however, well-known that both very low blood pressure (severe hypotension) and, adverse effects from medical interventions (e.g. vasopressors) that increase blood pressure, can increase the risk of death.
Current guidelines recommend that clinicians aim for a mean arterial pressure (MAP) of 65 mmHg or more. These guidelines are based on low quality evidence and no guidance is given on an upper limit. Previous research shows MAP values in critical care frequently rise significantly higher than 65 mmHg, thus exposing patients to potentially unnecessary doses of vasopressors and associated side-effects (e.g. abnormal heart rhythm, heart muscle damage, renal failure and insufficient blood flow to the intestines and limbs).
This research is important to patients because of emerging evidence from a (currently unpublished) meta-analysis suggesting that using a lower MAP target (permissive hypotension) to guide treatment may increase survival in older critically ill patients. A large clinical trial is therefore needed to evaluate this idea. The 65 Trial will evaluate the clinical and cost-effectiveness of permissive hypotension (MAP target of 60 - 65 mmHg during vasopressor therapy) in critically ill patients aged 65 years or over with hypotension.
The 65 Trial tests the idea that the overall benefits associated with permissive hypotension will outweigh the risks associated with lower MAP values and with medical interventions used to raise blood pressure.
The 65 Trial is funded by the National Institute for Health Research, Health Technology Assessment Programme and will take place in 65 NHS hospitals over 18 months. The following patients will be eligible:
• age 65 years or older
• vasodilatory hypotension
• decision to start vasopressors or started within prior 6 hours following/during adequate fluid resuscitation
• vasopressors expected to continue for 6 hours or moreREC name
South Central - Oxford C Research Ethics Committee
REC reference
17/SC/0142
Date of REC Opinion
24 Apr 2017
REC opinion
Further Information Favourable Opinion