Clinical trial NCT04894045: Perioperative Personalized Blood Pressure Management
Official title: Perioperative Personalized Blood Pressure Management in Patients Having Major Surgery: a Bicentric Prospective Randomized Controlled Interventional Pilot Trial (IMPROVE-pilot)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Pressure
Intraoperative Hypotension
Postoperative Complications
Keywords: Blood Pressure
Intraoperative Hypotension
Cardiovascular Dynamics
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
Collaborators: name: RWTH Aachen University
First posted: 2021-05-20
Enrollment: 105
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Individualized MAP target value
timeFrame: 1 day before surgery
Secondary outcomes:
measure: Proportion of patients with calculated MAP target
timeFrame: day of surgery
measure: Duration and severity of MAP below MAP target
timeFrame: day of surgery
Other outcomes:
measure: Incidence of myocardial injury after non-cardiac surgery
timeFrame: baseline, postoperative days 1, 2 and 3
measure: Incidence of acute kidney injury
timeFrame: baseline, postoperative day 1, 2 and 3
Locations:
city: Aachen
country: Germany
facility: University Hospital RWTH Aachen
city: Hamburg
country: Germany
facility: Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf
Study officials:
affiliation: Department of Anesthesiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
name: Bernd Saugel, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Anesthesiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
name: Karim Kouz, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Salmasi V, Maheshwari K, Yang D, Mascha EJ, Singh A, Sessler DI, Kurz A. Relationship between Intraoperative Hypotension, Defined by Either Reduction from Baseline or Absolute Thresholds, and Acute Kidney and Myocardial Injury after Noncardiac Surgery: A Retrospective Cohort Analysis. Anesthesiology. 2017 Jan;126(1):47-65. doi: 10.1097/ALN.0000000000001432.
citation: Sessler DI, Bloomstone JA, Aronson S, Berry C, Gan TJ, Kellum JA, Plumb J, Mythen MG, Grocott MPW, Edwards MR, Miller TE; Perioperative Quality Initiative-3 workgroup; POQI chairs; Miller TE, Mythen MG, Grocott MP, Edwards MR; Physiology group; Preoperative blood pressure group; Intraoperative blood pressure group; Postoperative blood pressure group. Perioperative Quality Initiative consensus statement on intraoperative blood pressure, risk and outcomes for elective surgery. Br J Anaesth. 2019 May;122(5):563-574. doi: 10.1016/j.bja.2019.01.013. Epub 2019 Feb 27.