Perioperative Personalized Blood Pressure Management: IMPROVE-multi (IMPROVE)

December 5, 2024 updated by: Universitätsklinikum Hamburg-Eppendorf

Effect of Personalized Perioperative Blood Pressure Management on Postoperative Complications and Mortality in High-risk Patients Having Major Abdominal Surgery: a Multicenter Prospective Randomized Controlled Interventional Clinical Trial

Rates of major complications and mortality in the first weeks after surgery remain very high: postoperative mortality is still around 2% in central Europe and the United States. Postoperative deaths are a consequence of postoperative complications. Postoperative complications that are most strongly associated with postoperative death include acute kidney injury and acute myocardial injury. To avoid postoperative complications it is thus crucial to identify and address modifiable risk factors for complications. One of these modifiable risk factors may be intraoperative hypotension. Intraoperative hypotension is associated with major postoperative complications including acute kidney injury, acute myocardial injury, and death. It remains unknown which blood pressure value should be targeted in the individual patient during surgery to avoid physiologically important intraoperative hypotension. In current clinical practice, an absolute mean arterial pressure threshold of 65mmHg is used as a lower "one-size-fits-all" intervention threshold. This "population harm threshold" is based on the results of retrospective studies. However, using this population harm threshold for all patients ignores the obvious fact that blood pressure varies considerably among individuals. In contrast to current "one-size-fits-all" perioperative blood pressure management, the investigators propose the concept of personalized perioperative blood pressure management. Specifically, the investigators propose to test the hypothesis that personalized perioperative blood pressure management reduces the incidence of a composite outcome of acute kidney injury, acute myocardial injury, non-fatal cardiac arrest, and death within 7 days after surgery compared to routine blood pressure management in high-risk patients having major abdominal surgery. The investigators will perform preoperative automated blood pressure monitoring for one night to define individual intraoperative blood pressure targets. Automated blood pressure monitoring is the clinical reference method to assess blood pressure profiles. The mission of the trial is to reduce postoperative morbidity and mortality after major surgery. The vision is to achieve this improvement in patient outcome by using the innovative concept of personalized perioperative blood pressure management. This trial is expected to change and improve current clinical practice and will have a direct impact on perioperative blood pressure management guidelines.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1272

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Bernd Saugel, M.D.
  • Phone Number: 004940741052415
  • Email: b.saugel@uke.de

Study Contact Backup

  • Name: Karim Kouz, M.D.
  • Phone Number: 004940741052415
  • Email: k.kouz@uke.de

Study Locations

  • Germany
      • Hamburg, Germany, 20246
        • Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Consenting patients ≥45 years scheduled for elective major abdominal surgery under general anesthesia that is expected to last ≥90 minutes AND

  • Presence of ≥1 of the following high-risk criteria:

    • exercise tolerance <4 metabolic equivalents as defined by the guidelines of the American College of Cardiology/American Heart Association
    • renal impairment (serum creatinine ≥1.3 mg/dL or estimated glomerular filtration rate <90 mL/min/1.73 m2 within the last 6 months)
    • coronary artery disease (any stage)
    • chronic heart failure (New York Heart Association Functional Classification ≥II)
    • valvular heart disease (moderate or severe)
    • history of stroke
    • peripheral arterial occlusive disease (any stage)
    • chronic obstructive pulmonary disease (any stage) or pulmonary fibrosis (any stage)
    • diabetes mellitus requiring oral hypoglycemic agent or insulin
    • immunodeficiency due to a disease (e.g., HIV, leukemia, multiple myeloma, solid organ cancer) or therapy (e.g., immunosuppressants, chemotherapy, radiation, steroids [above Cushing threshold])
    • liver cirrhosis (any Child-Pugh class)
    • body mass index ≥30 kg/m2
    • current smoking or 15 pack-year history of smoking
    • age ≥65 years
    • expected anesthesia duration >180 minutes
    • B-type natriuretic peptide (BNP) >80 ng/L or N-terminal B-type natriuretic peptide (NT-proBNP) >200 ng/L within the last 6 months

Exclusion Criteria:

  • emergency surgery
  • surgery: nephrectomy, liver or kidney transplantation
  • status post transplantation of kidney, liver, heart, or lung
  • sepsis (according to current Sepsis-3 definition)
  • American Society of Anesthesiologists physical status classification V or VI
  • pregnancy
  • patients on renal replacement therapy
  • impossibility of preoperative automated blood pressure monitoring

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Routine management (control) group
Routine intraoperative blood pressure management with a lower intervention threshold of 65 mmHg. In contrast to the patients assigned to 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.
Experimental: Personalized management (intervention) group
In patients randomized to the personalized management group, intraoperative mean arterial pressure will be maintained at least at the mean nighttime mean arterial pressure (assessed using preoperative automated blood pressure monitoring) with a minimum mean arterial pressure of 65 mmHg, and maximum mean arterial pressure of 110 mmHg. The perioperative trial intervention period starts with the beginning of the induction of general anesthesia and ends two hours after surgery ends.
Other: Personalized blood pressure management
Personalized blood pressure management: Intraoperative mean arterial pressure will be maintained at least at the mean nighttime mean arterial pressure (assessed using preoperative automated blood pressure monitoring) with a minimum mean arterial pressure of 65 mmHg, and maximum mean arterial pressure of 110 mmHg.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Composite outcome of major postoperative complications
Time Frame: Postoperative Day 7
Collapsed composite ("any event versus none") of acute kidney injury, acute myocardial injury (including myocardial infarction), non-fatal cardiac arrest, and death within 7 days after surgery
Postoperative Day 7

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Postoperative acute kidney injury
Time Frame: Postoperative Day 3
Incidence of acute kidney injury within 3 days after surgery
Postoperative Day 3
Postoperative acute kidney injury
Time Frame: Postoperative Day 7
Incidence of acute kidney injury within 7 days after surgery
Postoperative Day 7
Composite outcome of long-term postoperative complications
Time Frame: Postoperative Day 30
Collapsed incidence of need for renal replacement therapy, myocardial infarction, non-fatal cardiac arrest, and death within 30 days after surgery
Postoperative Day 30
Composite outcome of long-term postoperative complications
Time Frame: Postoperative Day 90
Collapsed incidence of need for renal replacement therapy, myocardial infarction, non-fatal cardiac arrest, and death within 90 days after surgery
Postoperative Day 90
Postoperative need for renal replacement therapy
Time Frame: Postoperative Day 30
Incidence of need for renal replacement therapy within 30 days after surgery
Postoperative Day 30
Postoperative need for renal replacement therapy
Time Frame: Postoperative Day 90
Incidence of need for renal replacement therapy within 90 days after surgery
Postoperative Day 90
Postoperative myocardial infarction
Time Frame: Postoperative Day 30
Incidence of myocardial infarction within 30 days after surgery
Postoperative Day 30
Postoperative myocardial infarction
Time Frame: Postoperative Day 90
Incidence of myocardial infarction within 90 days after surgery
Postoperative Day 90
Postoperative non-fatal cardiac arrest
Time Frame: Postoperative Day 30
Incidence of non-fatal cardiac arrest within 30 days after surgery
Postoperative Day 30
Postoperative non-fatal cardiac arrest
Time Frame: Postoperative Day 90
Incidence of non-fatal cardiac arrest within 90 days after surgery
Postoperative Day 90
Postoperative death
Time Frame: Postoperative Day 30
Incidence of death within 30 days after surgery
Postoperative Day 30
Postoperative death
Time Frame: Postoperative Day 90
Incidence of death within 90 days after surgery
Postoperative Day 90
Postoperative fever
Time Frame: Postoperative Day 7
Incidence of fever within 7 days after surgery
Postoperative Day 7
Postoperative respiratory infection
Time Frame: Postoperative Day 7
Incidence of respiratory infection within 7 days after surgery
Postoperative Day 7
Postoperative neurological infection
Time Frame: Postoperative Day 7
Incidence of neurological infection within 7 days after surgery
Postoperative Day 7
Postoperative urinary system infection
Time Frame: Postoperative Day 7
Incidence of urinary system infection within 7 days after surgery
Postoperative Day 7
Postoperative endometritis
Time Frame: Postoperative Day 7
Incidence of endometritis within 7 days after surgery
Postoperative Day 7
Postoperative deep incisional surgical site infection
Time Frame: Postoperative Day 7
Incidence of deep incisional surgical site infection within 7 days after surgery
Postoperative Day 7
Postoperative organ or space surgical site infection
Time Frame: Postoperative Day 7
Incidence of organ or space surgical site infection within 7 days after surgery
Postoperative Day 7
Postoperative sepsis
Time Frame: Postoperative Day 7
Incidence of sepsis within 7 days after surgery
Postoperative Day 7
Unplanned hospital re-admission
Time Frame: Postoperative Day 30
Incidence of unplanned hospital re-admission within 30 days after surgery
Postoperative Day 30
Composite outcome of major postoperative complications
Time Frame: Postoperative Day 3
Collapsed incidence of acute kidney injury, acute myocardial injury (including myocardial infarction), non-fatal cardiac arrest, and death within 3 days after surgery
Postoperative Day 3
Postoperative acute myocardial injury (including myocardial infarction)
Time Frame: Postoperative Day 3
Incidence of acute myocardial injury (including myocardial infarction) within 3 days after surgery
Postoperative Day 3
Postoperative acute myocardial injury (including myocardial infarction)
Time Frame: Postoperative Day 7
Incidence of acute myocardial injury (including myocardial infarction) within 7 days after surgery
Postoperative Day 7
Postoperative non-fatal cardiac arrest
Time Frame: Postoperative Day 3
Incidence of non-fatal cardiac arrest within 3 days after surgery
Postoperative Day 3
Postoperative non-fatal cardiac arrest
Time Frame: Postoperative Day 7
Incidence of non-fatal cardiac arrest within 7 days after surgery
Postoperative Day 7
Postoperative death
Time Frame: Postoperative Day 3
Incidence of death within 3 days after surgery
Postoperative Day 3
Postoperative death
Time Frame: Postoperative Day 7
Incidence of death within 7 days after surgery
Postoperative Day 7
Postoperative infectious complications
Time Frame: Postoperative Day 7
Collapsed incidence of fever, respiratory infection, neurological infection, urinary system infection, colitis or infection with Clostridium difficile, endometritis, surgical site infection, deep incisional surgical site infection, organ or space surgical site infection, unknown infection with pathogenic organisms in tissue or fluid, and sepsis within 7 days after surgery
Postoperative Day 7
Postoperative colitis or infection with Clostridium difficile
Time Frame: Postoperative Day 7
Incidence of colitis or infection with Clostridium difficile within 7
Postoperative Day 7
Postoperative surgical site infection
Time Frame: Postoperative Day 7
Incidence of surgical site infection within 7 days after surgery
Postoperative Day 7
Postoperative unknown infection with pathogenic organisms in tissue or fluid
Time Frame: Postoperative Day 7
Incidence of unknown infection with pathogenic organisms in tissue or fluid
Postoperative Day 7
Hospital discharge
Time Frame: Postoperative Day 90
Time-to-event outcome with the event "hospital discharge"
Postoperative Day 90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universitätsklinikum Hamburg-Eppendorf

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Cleveland Clinic
Jena University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Bernd Saugel, M.D., Department of Anesthesiology, University Medical Center Hamburg-Eppendorf

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 26, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 25, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 25, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 16, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 12, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 14, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 11, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ZKSJ0147

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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