Perioperative Personalized Blood Pressure Management

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

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).

Study Overview

• Status: Completed
• Conditions: Postoperative Complications; Blood Pressure; Intraoperative Hypotension
• Intervention / Treatment: Other: Personalized management

Detailed Description

not provided

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Aachen, Germany, 52074
    • University Hospital RWTH Aachen
  • Hamburg, Germany, 20246
    • Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Personalized management group; 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.	Other: Personalized management; 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.
No Intervention: Control group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 day before surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with calculated MAP target	- proportion of patients in whom preoperative automated blood pressure monitoring + calculation of target MAP is possible	day of surgery
Duration and severity of MAP below MAP target	- time weighted average MAP below individual MAP target	day of surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of myocardial injury after non-cardiac surgery	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.	baseline, postoperative days 1, 2 and 3
Incidence of acute kidney injury	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.	baseline, postoperative day 1, 2 and 3

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Collaborators: RWTH Aachen University
• Investigators: Principal Investigator: Bernd Saugel, Prof. Dr., Department of Anesthesiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Principal Investigator: Karim Kouz, Dr., Department of Anesthesiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 13, 2021
• Primary Completion (Actual): November 24, 2022
• Study Completion (Actual): November 27, 2022

Study Registration Dates

• First Submitted: April 24, 2021
• First Submitted That Met QC Criteria: May 15, 2021
• First Posted (Actual): May 20, 2021

Study Record Updates

• Last Update Posted (Estimate): February 28, 2023
• Last Update Submitted That Met QC Criteria: February 27, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Blood Pressure; Intraoperative Hypotension; Cardiovascular Dynamics
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Hypotension; Postoperative Complications
• Other Study ID Numbers: 2021-10462-BO-bet

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No