Perioperative Personalized Blood Pressure Management

Blood Pressure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04894045
• Other study ID #: 2021-10462-BO-bet
• Status: Completed
• Phase: N/A
• Start date: April 13, 2021
• Est. completion date: November 27, 2022

Study information

• Verified date: February 2023
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

not provided

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: November 27, 2022
• Est. primary completion date: November 24, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure
• Hypotension
• Intraoperative Hypotension
• Postoperative Complications

Intervention

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.

Locations

Country	Name	City	State
Germany	University Hospital RWTH Aachen	Aachen
Germany	Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf	Hamburg

Sponsors (2)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf	RWTH Aachen University

Country where clinical trial is conducted

Germany, 

References & 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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	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
Secondary	Duration and severity of MAP below MAP target	- time weighted average MAP below individual MAP target	day of surgery