Blood Pressure, Intraoperative Hypotension, Postoperative Complications
Conditions
Keywords
Blood Pressure, Intraoperative Hypotension, Cardiovascular Dynamics
Brief summary
The investigators propose a pilot trial to (1) proof the concept that defining the intraoperative mean arterial pressure (MAP) intervention threshold based on the mean nighttime MAP (assessed using preoperative automated blood pressure monitoring) results in clinically relevant (mean nighttime MAP ± 10 mmHg) different target values compared with using an absolute population-derived MAP intervention threshold of 65 mmHg (primary endpoint); (2) investigate if a personalized perioperative blood pressure management is feasibly in multi-center studies, especially if the target values can be sufficiently achieved (secondary endpoint); (3) study the impact of personalized perioperative blood pressure management on the incidence of myocardial injury after non-cardiac surgery (MINS) (exploratory endpoint); (4) study the impact of personalized perioperative blood pressure management on the incidence of acute kidney injury within the first three postoperative days according to the KDIGO (Kidney Disease: Improving Global Outcomes) definition without oliguric criteria (exploratory endpoint).
Detailed description
not provided
Interventions
OTHERPersonalized management
Intraoperative MAP will be maintained at least at the mean nighttime MAP (assessed using preoperative automated blood pressure monitoring). If the mean nighttime MAP is below 65 mmHg, intraoperative MAP will be maintained at least at 65 mmHg.
Sponsors
RWTH Aachen University
Universitätsklinikum Hamburg-Eppendorf
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
In control group patients, the treating anesthesiologists are blinded to the data of preoperative automated blood pressure monitoring. Participants and outcomes assessors are blinded to group allocation.
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 45 * American Society of Anesthesiologists physical status class (ASA) II-IV * scheduled for elective major surgery under general anesthesia * surgery expected to last ≥ 120 minutes
Exclusion criteria
* emergency surgery * patients having liver or kidney transplantation * laparoscopic surgery * pregnancy * status of post transplantation of kidney, liver, heart, or lung * sepsis (according to current Sepsis-3 definition) * impossibility of preoperative automated blood pressure monitoring * MAP differences between the right and the left arm of more than 20 mmHg surgery that requires controlled hypotension
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Individualized MAP target value | 1 day before surgery | Difference between intraoperative target MAP (defined as the mean nighttime MAP assessed using preoperative automated blood pressure monitoring) and 65 mmHg; we consider a difference \> ± 10 mmHg as clinically meaningful. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with calculated MAP target | day of surgery | \- proportion of patients in whom preoperative automated blood pressure monitoring + calculation of target MAP is possible |
| Duration and severity of MAP below MAP target | day of surgery | \- time weighted average MAP below individual MAP target |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence of myocardial injury after non-cardiac surgery | baseline, postoperative days 1, 2 and 3 | Incidence of myocardial injury after non-cardiac surgery assessed through measurement of baseline high-sensitivity troponin T (before surgery) and high-sensitivity troponin T on postoperative days 1,2, and 3. |
| Incidence of acute kidney injury | baseline, postoperative day 1, 2 and 3 | Incidence of acute kidney injury within the first three postoperative days according to the KDIGO definition without oliguric criteria assessed through measurement of baseline creatinine (before surgery) and creatinine after surgery on postoperative days 1, 2, and 3. |
Countries
Germany
Outcome results
None listed