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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03442907
Other study ID # IMPROVE-1.0
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2018
Est. completion date January 31, 2020

Study information

Verified date January 2021
Source Universitätsklinikum Hamburg-Eppendorf
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 368
Est. completion date January 31, 2020
Est. primary completion date October 10, 2019
Accepts healthy volunteers No
Gender All
Age group 50 Years to 110 Years
Eligibility 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

Study Design


Intervention

Procedure:
24 hour blood pressure measurement, fluids, vasopressors
Targeting individual blood blood pressure values during surgical procedures
Standard of Care
Treatment according to Standard of care at the Department of Anaesthesiology, University Medical Centre Hamburg Eppendorf

Locations

Country Name City State
Germany Klinik und Poliklinik für Anästhesiologie, Zentrum für Anästhesiologie und Intensivmedizin, Universitätsklinikum Hamburg-Eppendorf Hamburg

Sponsors (1)

Lead Sponsor Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Composite endpoint: Incidence of POCD or delirium POCD is measured on the basis of a neuropsychological test battery and the delirium on the basis of the CAM-ICU test. 3rd-7th postoperative day
Secondary Kidney function Glomerular filtration rate; calculated 24h, 48h and 72h after surgery (Cockcroft-Gault equation) 24, 48 and 72 hrs after surgery
Secondary cardiac ischemia high-sensitive troponin T measurements are performed prior and 6 hours after surgery 6 hours after surgery
Secondary length of hospital stay 30 days
Secondary 30-day mortality 30 days
Secondary 30-day morbidity European perioperative outcome definitions 30 days
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