Perioperative Personalized Blood Pressure Management

NCT04894045 | Completed

• 1 other identifier: 2021-10462-BO-bet
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 2

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).

Conditions

Blood Pressure; Intraoperative Hypotension; Postoperative Complications

Keywords

Blood Pressure; Intraoperative Hypotension; Cardiovascular Dynamics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Proportion of patients with calculated MAP target

  day of surgery

• Duration and severity of MAP below MAP target

  day of surgery

Other Outcomes (2)

• Incidence of myocardial injury after non-cardiac surgery

  baseline, postoperative days 1, 2 and 3

• Incidence of acute kidney injury

  baseline, postoperative day 1, 2 and 3

Study Arms (2)

Personalized management group

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.

Other: Personalized management

Control group

NO INTERVENTION

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.

Interventions

Personalized management 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.

Personalized management group

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead
• RWTH Aachen University: collaborator

Study Sites (2)

University Hospital RWTH Aachen

Aachen, 52074, Germany

Location

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

Hamburg, 20246, Germany

Location

Related Publications (2)

• 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.

  PMID: 27792044 BACKGROUND

• 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.

  PMID: 30916004 BACKGROUND

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2021
• First Posted: May 20, 2021
• Study Start: April 13, 2021
• Primary Completion: November 24, 2022
• Study Completion: November 27, 2022
• Last Updated: February 28, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)