Blood Pressure, Intraoperative Hypotension, Postoperative Complications
Conditions
Brief summary
The aim of this research project is to find out whether a personalized definition of the lower blood pressure threshold based on the individual blood pressure profile by means of preoperative 24-hour blood pressure measurement can reduce organ damage (brain, kidney, heart) through reduced blood flow during surgery.
Interventions
PROCEDURE24 hour blood pressure measurement, fluids, vasopressors
Targeting individual blood blood pressure values during surgical procedures
PROCEDUREStandard of Care
Treatment according to Standard of care at the Department of Anaesthesiology, University Medical Centre Hamburg Eppendorf
Sponsors
Universitätsklinikum Hamburg-Eppendorf
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 110 Years
Healthy volunteers
No
Inclusion criteria
* age ≥ 50 years * ASA II-IV (Classification of the American Society of Anesthesiologists for the assessment of the perioperative risk depending on the underlying diseases) * duration of intervention in general anesthesia at least 90 minutes
Exclusion criteria
* Pregnancy * Emergency procedures * Surgery requiring controlled hypotension (e.g., aneurysm) * Cerebrovascular events in the past medical history * Patients of cardiac surgery, vascular surgery, neurosurgery, and transplantation surgery * Pre-existing dementia (anamnesis) * kidney transplant * dialysis-dependent renal insufficiency (KDIGO criteria) * no patient consent * failure to meet the inclusion criteria * Impossibility of 24-h blood pressure measurement
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite endpoint: Incidence of POCD or delirium | 3rd-7th postoperative day | POCD is measured on the basis of a neuropsychological test battery and the delirium on the basis of the CAM-ICU test. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Kidney function | 24, 48 and 72 hrs after surgery | Glomerular filtration rate; calculated 24h, 48h and 72h after surgery (Cockcroft-Gault equation) |
| cardiac ischemia | 6 hours after surgery | high-sensitive troponin T measurements are performed prior and 6 hours after surgery |
| length of hospital stay | 30 days | — |
| 30-day mortality | 30 days | — |
| 30-day morbidity | 30 days | European perioperative outcome definitions |
Countries
Germany
Outcome results
None listed