Postoperative Complications Clinical Trial
— NiMonOfficial title:
Continuous Vs Intermittent Non Invasive Blood Pressure Monitoring in Preventing Post Operative Organ Failure
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 |
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
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 |
Country | Name | City | State |
---|---|---|---|
Italy | A.O.U. G.Martino - University of Messina | Messina |
Lead Sponsor | Collaborator |
---|---|
University of Messina | Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva |
Italy,
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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