Perioperative Personalized Blood Pressure Management

• ClinicalTrials.gov Identifier: NCT04894045
• Recruitment Status: Completed
• First Posted: May 20, 2021
• Last Update Posted: February 28, 2023
• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Collaborator: RWTH Aachen University
• Information provided by (Responsible Party): Universitätsklinikum Hamburg-Eppendorf

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Blood Pressure; Intraoperative Hypotension; Postoperative Complications	Other: Personalized management	Not Applicable

Detailed Description:

not provided

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 105 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Masking Description: In control group patients, the treating anesthesiologists are blinded to the data of preoperative automated blood pressure monitoring. Participants and outcomes assessors are blinded to group allocation.
• Primary Purpose: Treatment
• Official Title: Perioperative Personalized Blood Pressure Management in Patients Having Major Surgery: a Bicentric Prospective Randomized Controlled Interventional Pilot Trial (IMPROVE-pilot)
• Actual Study Start Date: April 13, 2021
• Actual Primary Completion Date: November 24, 2022
• Actual Study Completion Date: November 27, 2022

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

1. 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
2. Duration and severity of MAP below MAP target [ Time Frame: day of surgery ]
   - time weighted average MAP below individual MAP target

Other Outcome Measures:

1. 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.
2. 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.

Eligibility Criteria

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

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

Contacts and Locations

Locations

Germany

University Hospital RWTH Aachen

Aachen, Germany, 52074

Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf

Hamburg, Germany, 20246

Sponsors and Collaborators

Universitätsklinikum Hamburg-Eppendorf

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

More Information

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.

• Responsible Party: Universitätsklinikum Hamburg-Eppendorf
• ClinicalTrials.gov Identifier: NCT04894045
• Other Study ID Numbers: 2021-10462-BO-bet
• First Posted: May 20, 2021
• Last Update Posted: February 28, 2023
• Last Verified: February 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Universitätsklinikum Hamburg-Eppendorf:

Blood Pressure; Intraoperative Hypotension; Cardiovascular Dynamics

Additional relevant MeSH terms:

Hypotension; Postoperative Complications; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes