Perioperative Personalized Blood Pressure Management

Study Overview
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Brief Summary
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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
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not provided

Official Title
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Perioperative Personalized Blood Pressure Management in Patients Having Major Surgery: a Bicentric Prospective Randomized Controlled Interventional Pilot Trial (IMPROVE-pilot)

Conditions
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Blood Pressure, Intraoperative Hypotension, Postoperative Complications

Intervention / Treatment
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* Other: Personalized management


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Personalized management group<br>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. | Other: Personalized management<br>* 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.<br>|
| No Intervention: Control group<br>Routine intraoperative blood pressure management with a lower intervention threshold of 65 mmHg. In contrast to the patients in the personalized management group, the individual mean nighttime MAP assessed using preoperative automated blood pressure monitoring is not taken into account and the treating anesthesiologists are blinded to the data of preoperative automated blood pressure monitoring. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Individualized MAP target value | 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. | 1 day before surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with calculated MAP target | - proportion of patients in whom preoperative automated blood pressure monitoring + calculation of target MAP is possible | day of surgery | 
| Duration and severity of MAP below MAP target | - time weighted average MAP below individual MAP target | day of surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blood Pressure, Intraoperative Hypotension, Cardiovascular Dynamics