Perioperative Personalized Blood Pressure Management

Sponsor
Universitätsklinikum Hamburg-Eppendorf (Other)
Overall Status
Recruiting
CT.gov ID
NCT04894045
Collaborator
RWTH Aachen University (Other)
200
2
2
20.6
100
4.9

Study Details

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
  • Other: Personalized management
N/A

Detailed Description

not provided

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 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 :
Apr 13, 2021
Anticipated Primary Completion Date :
Nov 30, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Individualized MAP target value [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 [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 [day of surgery]

    - time weighted average MAP below individual MAP target

Other Outcome Measures

  1. Incidence of myocardial injury after non-cardiac surgery [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 [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

Criteria

Ages Eligible for Study:
45 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Site City State Country Postal Code
1 University Hospital RWTH Aachen Aachen Germany 52074
2 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

Study Documents (Full-Text)

None provided.

More Information

Publications

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:
Jun 8, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 8, 2022