Perioperative Personalized Blood Pressure Management in Patients Having Major Surgery: a Bicentric Prospective Randomized Controlled Interventional Pilot Trial (IMPROVE-pilot)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Blood Pressure
- Sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Enrollment
- 105
- Locations
- 2
- Primary Endpoint
- Individualized MAP target value
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Outcomes
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
- Duration and severity of MAP below MAP target(day of surgery)
- Proportion of patients with calculated MAP target(day of surgery)