Perioperative Personalized Blood Pressure Management

NCT ID: NCT04894045

Last Updated: 2023-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-13
• Study Completion Date: 2022-11-27

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

Conditions

Blood Pressure; Intraoperative Hypotension; Postoperative Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: OTHER

Personalized management

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RWTH Aachen University

OTHER

Sponsor Role: collaborator

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bernd Saugel, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany

Karim Kouz, Dr.

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany

Locations

University Hospital RWTH Aachen

Aachen, , Germany

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

Hamburg, , Germany

Countries

Germany

References

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.

Reference Type: BACKGROUND

PMID: 27792044 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30916004 (View on PubMed)

Other Identifiers

2021-10462-BO-bet

Identifier Type: -

Identifier Source: org_study_id