Intraoperative hypotension, postoperative disability and outcome
Conditions
Interventions
The proactive strategy consists of two components: 1) a target blood pressure that provides a sufficient safety margin above the minimal acceptable threshold of a MAP of 65 mmHg
2) a guideline with suggestions how to keep patients at their target blood pressure.
Patients with a high likelihood of IOH require larger safety margins and thus higher target blood pressures compar
Sponsors
University Medical Center Utrecht, The Netherlands
Eligibility
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: • Adult =18 years or older • Elective, non-cardiac surgery under general anaesthesia or central neuraxial anaesthesia • Expected hospital stay of at least one night after surgery
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: • Low risk surgery: Opthalmic surgery, endoscopic gastrointestinal procedures, (interventional) radiologic procedures, obstetric procedure • Organ transplantation • Procedures with a scheduled surgical time of less than 30 minutes • Participation in another clinical trial that is interfering with the procedures and outcomes of the PRETREAT trial • Patients unable to fully comply to study needs (e.g. legally incapable patients or patients unable to communicate in Dutch or English). • Patients with an American Society of Anaesthesiologists (ASA) Physical status 5
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is disability at six months after surgery, measured by the 12-item World Health Organization Disability Assessment Score (WHODAS) 2.0 scale. The WHODAS scale records difficulties experienced in different functional domains including, cognition, mobility, self-care, getting along, life activities and participation during the previous 30 days. Disability is defined as a decrement in each functioning domain corresponding to score between 0% and 100%, in which no disability stands for a score of 0% and full disability represents a score of 100%, including death. The WHODAS 2.0 is easy to use and patient centered. In a validation study including non-cardiac surgical patients, the WHODAS 2.0 has been found to be a clinically acceptable, valid, reliable and responsive instrument for measuring postoperative disability. Moreover, as multiple organ systems are susceptible to low organ perfusion, the primary endpoint of the study should reflect the variation in possible adverse effects of IOH, not only a specific organ injury due to possible hypoperfusion. Hence, the primary endpoint is measured with the 12-item WHODAS 2.0 scale. The primary endpoint will be collected using Castor EDC. | — |
Secondary
| Measure | Time frame |
|---|---|
| Endpoints: patient level • Disability at 30 days after surgery, measured with the 12-item WHODAS 2.0 • Quality of life at 30 days and 6 months postoperatively, measured with the EuroQoL 5D-5L questionnaire • In-hospital mortality within 48 hours and during hospital stay • All-cause mortality within 6 months • Length of hospital stay • Troponin in first week after surgery when available from routine clinical care • Creatinine in first week after surgery when available from routine clinical care • Intensive Care admission during hospital stay • Non-prophylactic antibiotics during hospital stay in first week after surgery • Readmission at the same hospital within 6 months after surgery • Reoperation during hospital stay • Hemorrhage requiring blood transfusion after surgery • Onset of cardiac complications 24 hours after surgery (new-onset atrial fibrillation & new-onset heart failure and/or ischemia) • In-hospital life-threatening events (shock, deep vein thrombosis or pulmonary embolism, myocardial infarction, cerebral vascular accident, acute kidney injury) Endpoints: process level • The incidence of intraoperative hypotension (MAP 130) • The depth and duration of intraoperative hypotension (MAP 130) • Estimated intraoperative blood loss in ml Endpoints: behavioral level • Intraoperative anaesthetic/analgesic drug use • Average intraoperative use of the following blood pressure interventions (vasopressor use, inotropic use, intravenous fluid administration, blood products administration) • Time to first blood pressure intervention after MAP drops below target blood pressure at any point during the anaesthetic case Determinants • Disability before surgery, measured with the 12-item WHODAS 2.0 • Quality of life before surgery, measured with the EuroQoL 5D-5L questionnaire • Gender • Age • Surgery specialty • Duration of procedure (planned duration, actual duration) • ASA-class • Comorbidity (hypertension, cardiac diseases, diabetes) • Type of anesthesia (general | — |
Contacts
Public ContactTeus Kappen
UMC Utrecht
Outcome results
None listed