Perioperative Personalized Blood Pressure Management

Universitätsklinikum Hamburg-Eppendorf105 enrolled

Overview

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).

not provided

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

105

Conditions

Blood Pressure Intraoperative Hypotension

Eligibility

Sex: ALLMin age: 45 Years

Medical Language ↔ Plain English

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

Locations (2)

University Hospital RWTH Aachen

Aachen, Germany

Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf

Hamburg, Germany

Outcomes

Primary Outcomes

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.

Time frame: 1 day before surgery

Secondary Outcomes

Proportion of patients with calculated MAP target

\- proportion of patients in whom preoperative automated blood pressure monitoring + calculation of target MAP is possible

Time frame: day of surgery

Duration and severity of MAP below MAP target

\- time weighted average MAP below individual MAP target