I95.2
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Elective, non-cardiac surgery under general anesthesia Indication for invasive blood pressure monitoring (IBP) according to institutional standard operating procedures (SOPs) Ability to provide informed consent
Exclusion criteria
Exclusion criteria: Pregnant individuals and children Patients unable to understand the study information and/or provide informed consent Preoperative requirement for intensive care Conditions associated with significant inter-arm blood pressure differences Contraindications to the placement of invasive blood pressure monitoring (IBP) Severe aortic stenosis, pheochromocytoma, hypertrophic obstructive cardiomyopathy, heart failure with reduced ejection fraction (HFrEF) Chronic medication with norepinephrine or dopamine reuptake inhibitors, tricyclic antidepressants, or monoamine oxidase inhibitors (MAOIs) End-stage renal disease requiring dialysis (CKD stage 5)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PIH – defined as a mean arterial pressure (MAP) < 65 mmHg during the first 15 minutes after induction of anesthesia, quantified as the area under the curve (AUC) below a MAP of 65 mmHg. The unit for this endpoint measurement is mmHg × min (millimetres of mercury multiplied by minutes) | — |
Secondary
| Measure | Time frame |
|---|---|
| AUC below MAP thresholds of 60, 50, and 40 mmHg (mmHg × min) Duration of MAP values <65, <60, <50, and <40 mmHg (minutes) Proportion of patients with any MAP measurement <65, <60, <50, and <40 mmHg (%) Proportion of patients with MAP values <65, <60, <50, and <40 mmHg sustained for at least one minute (%) AUC above MAP thresholds of 100, 110, 120, and 140 mmHg (mmHg × min) Standard deviation of MAP (mmHg) Cumulative dose of vasopressors (mg) Cumulative volume of crystalloids administered (ml) Postoperative myocardial injury (defined as an elevation of high-sensitivity troponin T [hsTnT] above the 99th percentile) Postoperative acute kidney injury (AKI), defined as an increase in serum creatinine (sCr) = 0.3 mg/dL within 48 hours Maximum serum creatinine within the first 2 postoperative days Postoperative delirium, assessed in the PACU and on postoperative days 1 and 2 (using Nu-DESC and CAM-ICU) Incidence of ICU admission | — |
Countries
Germany
Contacts
Charité - Universitätsmedizin Berlin, Klinik für Anästhesiologie und Intensivmedizin