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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05496322
Other study ID # 16-22
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 26, 2023
Est. completion date December 2025

Study information

Verified date May 2024
Source University of Messina
Contact Alberto Noto
Phone +390902212450
Email alberto.noto@unime.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Continuous non-invasive arterial pressure monitoring has the potential to decrease the duration of intraoperative hypotension and hypertension compared to conventional intermittent blood pressure monitoring. Chen et al. demonstrated using continuous non-invasive arterial pressure devices for every hour of surgery it is possible to identify an average of 14 minutes of potentially treatable hypotensive and hypertensive time(12). Whether the ability to detect more hypotension events by continuous non-invasive arterial pressure monitoring use can improve patient outcomes, is still an open research question


Recruitment information / eligibility

Status Recruiting
Enrollment 1265
Est. completion date December 2025
Est. primary completion date January 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - All adult (age =18 years) patients scheduled for elective non-cardiac surgery in participating centers - Surgical case planned with non invasive blood pressure monitoring according to local clinical practice or policies. Exclusion Criteria: - Missing of preoperative serum creatinine during 30 days prior surgery - Preoperative dialysis - Chronic kidney disease (eGFR < 60ml/min Cockcroft-Gault equation) - Surgical procedure lasting less than 60 min - Planned use of permissive hypotension - Urological procedures (including nephrectomy and renal transplantation) - Refusal to give informed consent

Study Design


Intervention

Device:
Continuous Non Invasive Blood Pressure Monitoring
Continuous non-invasive arterial pressure monitoring
Intermittent Non Invasive Blood Pressure Monitoring
Intermittent non-invasive arterial pressure monitoring

Locations

Country Name City State
Italy A.O.U. G.Martino - University of Messina Messina

Sponsors (2)

Lead Sponsor Collaborator
University of Messina Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Post operative myocardial injury The primary outcome will be the proportions of myocardial injury (Definitions: elevation of serum Troponin T (TnT) >= 30 ng/L in the first post-operative week) 1 week
Secondary Post operative Acute kidney injury Proportions of postoperative AKI (Definition: increase in postoperative serum creatinine concentration during the first 7 postoperative days by more than 1.5-fold or greater than 0.3 mg/dl. Preoperative concentration was defined as the most recent recorded measurement within 30 days before the surgery) 1 week
Secondary Post operative death Death during postoperative hospital stay 28 day after surgery
Secondary Events 30d post surgery Any of the following events after surgery: Stroke, Non fatal cardiac arrest, AKI stage 2-3, Sepsis, Death) 30 days after surgery
Secondary Events 90d post surgery Any of the following events after surgery: Stroke, Non fatal cardiac arrest, AKI stage 2-3, Sepsis, Death) 90 days after surgery
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