Completed

NCT Number: NCT04894045

Perioperative Personalized Blood Pressure Management

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).

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Key information

Conditions

Blood Pressure Intraoperative Hypotension Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital RWTH Aachen, Aachen, Germany

About this study

not provided

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Personalized management

Other

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.

Primary outcomes

Individualized MAP target value

Time frame: 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 outcomes

Proportion of patients with calculated MAP target

Time frame: 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

Time frame: day of surgery
- time weighted average MAP below individual MAP target

Other outcomes

Incidence of myocardial injury after non-cardiac surgery

Time frame: 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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Collaborators

RWTH Aachen University

Registry information

Official study title

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

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2022
First posted: May 20, 2021
Registry last updated: Feb 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed