Perioperative Personalized Blood Pressure Management

Universitätsklinikum Hamburg-Eppendorf

Status: Completed

Conditions: Postoperative Complications; Intraoperative Hypotension; Blood Pressure

Treatments: Other: Personalized management

Study type: Interventional

Funder types: Other

Identifiers

NCT04894045

2021-10462-BO-bet

Details and patient eligibility

About

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).

Full description

not provided

Enrollment: 105 patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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105 participants in 2 patient groups

Personalized management group

Other group

Description:

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.

Treatment:

Other: Personalized management

Control group

No Intervention group

Description:

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.