Personalized Blood Pressure Management

NCT ID: NCT03442907

Last Updated: 2021-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

368 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-01

Study Completion Date

2020-01-31

Brief Summary

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The aim of this research project is to find out whether a personalized definition of the lower blood pressure threshold based on the individual blood pressure profile by means of preoperative 24-hour blood pressure measurement can reduce organ damage (brain, kidney, heart) through reduced blood flow during surgery.

Detailed Description

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Conditions

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Blood Pressure Intraoperative Hypotension Postoperative Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Study group

The intraoperative blood pressure target for all patients in the study group is the mean arterial pressure (+ 10mmHg maximum) derived from the prior 24-hour blood pressure measurement.

To achieve the blood pressure target, fluid or vasoactive substances will be used.

Group Type EXPERIMENTAL

24 hour blood pressure measurement, fluids, vasopressors

Intervention Type PROCEDURE

Targeting individual blood blood pressure values during surgical procedures

Control group

Study patients of the control group are treated according to the standard operating procedures (SOP) of the Department of Anaesthesiology, University Medical Centre Hamburg Eppendorf.

Group Type ACTIVE_COMPARATOR

Standard of Care

Intervention Type PROCEDURE

Treatment according to Standard of care at the Department of Anaesthesiology, University Medical Centre Hamburg Eppendorf

Interventions

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24 hour blood pressure measurement, fluids, vasopressors

Targeting individual blood blood pressure values during surgical procedures

Intervention Type PROCEDURE

Standard of Care

Treatment according to Standard of care at the Department of Anaesthesiology, University Medical Centre Hamburg Eppendorf

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* age ≥ 50 years
* ASA II-IV (Classification of the American Society of Anesthesiologists for the assessment of the perioperative risk depending on the underlying diseases)
* duration of intervention in general anesthesia at least 90 minutes

* Impossibility of 24-h blood pressure measurement

Exclusion Criteria

* Pregnancy
* Emergency procedures
* Surgery requiring controlled hypotension (e.g., aneurysm)
* Cerebrovascular events in the past medical history
* Patients of cardiac surgery, vascular surgery, neurosurgery, and transplantation surgery
* Pre-existing dementia (anamnesis)
* kidney transplant
* dialysis-dependent renal insufficiency (KDIGO criteria)
* no patient consent
Minimum Eligible Age

50 Years

Maximum Eligible Age

110 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Klinik und Poliklinik für Anästhesiologie, Zentrum für Anästhesiologie und Intensivmedizin, Universitätsklinikum Hamburg-Eppendorf

Hamburg, , Germany

Site Status

Countries

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Germany

References

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Nicklas JY, Bergholz A, Dake F, Pham HHD, Rabe MC, Schlichting H, Skrovanek S, Flick M, Kouz K, Fischer M, Olotu C, Izbicki JR, Mann O, Fisch M, Schmalfeldt B, Frosch KH, Renne T, Krause L, Zollner C, Saugel B. Personalised blood pressure management during major noncardiac surgery and postoperative neurocognitive disorders: a randomised trial. BJA Open. 2024 Jul 1;11:100294. doi: 10.1016/j.bjao.2024.100294. eCollection 2024 Sep.

Reference Type DERIVED
PMID: 39050403 (View on PubMed)

Other Identifiers

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IMPROVE-1.0

Identifier Type: -

Identifier Source: org_study_id

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