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Completed

NCT Number: NCT03442907

Personalized Blood Pressure Management

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.

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Key information

Conditions

Blood Pressure Intraoperative Hypotension Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

50 year–110 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Hamburg, 20246, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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
  • failure to meet the inclusion criteria
  • Impossibility of 24-h blood pressure measurement

Treatment and study plan

24 hour blood pressure measurement, fluids, vasopressors

Procedure

Targeting individual blood blood pressure values during surgical procedures

Standard of care

Procedure

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

Primary outcomes

  1. Composite endpoint: Incidence of POCD or delirium

    Time frame: 3rd-7th postoperative day

    POCD is measured on the basis of a neuropsychological test battery and the delirium on the basis of the CAM-ICU test.

Secondary outcomes

  1. Kidney function

    Time frame: 24, 48 and 72 hrs after surgery

    Glomerular filtration rate; calculated 24h, 48h and 72h after surgery (Cockcroft-Gault equation)

  2. cardiac ischemia

    Time frame: 6 hours after surgery

    high-sensitive troponin T measurements are performed prior and 6 hours after surgery

  3. length of hospital stay

    Time frame: 30 days

  4. 30-day mortality

    Time frame: 30 days

  5. 30-day morbidity

    Time frame: 30 days

    European perioperative outcome definitions

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Registry information

Official study title

Intraoperative Blood Pressure Management Based on the Individual Blood Pressure Profile: Impact on Postoperative Organ Function

Acronym: IMPROVE

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Feb 22, 2018
Registry last updated
Jan 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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