The effect of proactive versus reactive treatment of hypotension on postoperative disability and outcome in surgical patients under anesthesia (PRETREAT): an adaptive, multicenter randomized controlled trial
Recruiting
- Conditions
- Postoperatief functioneren en kwaliteit van levenHypotensionlow blood pressure1002859310038430
- Registration Number
- NL-OMON55117
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 5000
Inclusion Criteria
Adult patients scheduled for elective non-cardiac surgery under general
anesthesia or central neuraxial anesthesia with a scheduled stay at the
hospital after surgery of at least one night - i.e. inpatients - will be
considered eligible for inclusion
Exclusion Criteria
Patients will be excluded when scheduled for low risk surgery, such as
ophthalmic surgery, endoscopic gastrointestinal procedures, and
(interventional) radiologic procedures. Also all other procedures under 30
minutes and obstetric or organ transplantations will be excluded.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcome of the study is persistent functional disability at six<br /><br>months after surgery, measured with the 12-item WHODAS 2.0 questionnaire</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcomes for the trial are: functional disability after 30 days<br /><br>(WHODAS 2.0), quality of live after 30 days and six months (EQ-5D-5L<br /><br>questionnaire), six-months mortality, in-hospital mortality, length of hospital<br /><br>stay, and in-hospital complications, i.e. acute kidney injury, myocardial<br /><br>injury, stroke, unexpected admission at the intensive care unit, and<br /><br>postoperative use of non-prophylactic antibiotics. </p><br>