NCT05960604Recruiting
Pressure Recording Analytical Method Parameters and Their Relationship With Hypotension in Hypertensive Patients
Observational Study to Evaluate the Pressure Recording Analytical Method Parameters in Patients Susceptible to Post-induction Hypotension Due to Hypertension, Diabetes Mellitus, Cardiovascular Risk Factors, or Major Surgery
Source: ClinicalTrials.gov · Last updated 9 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Perioperative anesthesiologists can benefit from easily obtainable hemodynamic variables detecting or quantifying the lack of an adequate compensatory capacity of the cardiovascular system in order to optimize patient management and improve patient outcomes. Parameters of the Pressure Recording Analytical Method (PRAM; Vygon, Padua, Italy) of the MostCare system, specifically cardiac cycle efficiency has been proposed as such variables. Yet, their value in anesthesia and especially in hypertensive patients is not studied. The goal of the PRAM-in-HYPO study is to prospectively evaluate the relationship between cardiac reserve and efficiency and cardiovascular risk factors in patients wo will undergo major surgical procedures using the state-of-the-art hemodynamic monitors. Also the investigators aim to build a predictive model to identify patients with decreased cardiac reserve due to hypertension and other cardiovascular risk factors, who are susceptible to post-induction hypotension. The investigators seek to include high-risk patients or patients presenting for major surgery, who are monitored with an advanced hemodynamic monitor to adequately evaluate the differences in cardiac reserve and cardiac efficiency.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 660 (estimated)
- First submitted
- 7 Apr 2023
- Start date
- 19 Feb 2024
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Recep Tayyip Erdogan University
- Diseases
- Stroke, High blood pressure
- NCT number
- NCT05960604
What you commit to
- Study type: Observational
- Planned participants: 660
- From 19 Feb 2024 to the primary completion date, 31 Dec 2026
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Preoperatively receiving vasoactive drugs
- Ongoing renal replacement therapy
Other illness
- Cardiac arrhythmia
- Presence of intraabdominal hypertension
- New York Heart Association Class 3-4 heart failure
Lab values
- Congestive heart failure with ejection fraction \< 35%
Other
- Refuse to consent to the study
- Arterial wave form distortion
- Inappropriate identification of the dicrotic notch for any reason
- Planned intraoperative mean arterial blood pressure \< 65 mmHg
- Hemodynamic instability defined as mean arterial blood pressure \< 65 mmHg
- Preoperative requirement of inotrope/vasopressor infusion
- Patients fitted with an intra-aortic balloon pump
- Patients fitted with Extracorporeal Membrane Oxygenation
- Critically ill patients requiring preoperative intensive care unit
- Glomerular filtration rate \< 30 ml/min/1.73 m2
Who the study is looking for
- Age at least 18 years
- Undergoing major surgery under general anesthesia
- Expected surgery time \>2 h
- Expected length of postoperative stay \>2 d
- Invasive blood pressure (radial or femoral) and Mostcare monitoring
- Indication for a passive leg raising test: risk of hypovolemia (preoperative fasting, bowel preparation, loss of appetite, limited access to water) or expected major surgery, expected blood loss, cardiovascular comorbidity (hypertension, diabetes mellitus, coronary artery disease, peripheral artery disease, hyperlipidemia, morbidity, active smoking).
- Recruitment after booking for surgery with sufficient time to read, understand and question study patient information prior to attending for surgery.
- Ability and willingness to provide informed consent
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Gazi University Medical Faculty, Department of Anesthesiology and Reanimation Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Recruiting |
| Erzurum Atatürk University Medical Faculty, Department of Anesthesiology and Reanimation Coordinator of this site? Confirm its status | Erzurum | Turkey (Türkiye) | Recruiting |
| Başakşehir Çam ve Sakura City Hospital, University Medical Faculty, Anesthesiology and Reanimation Clinic Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Recruiting |
| Acıbadem University Medical Faculty, Department of Anesthesiology and Reanimation Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Recruiting |
| Recep Tayyip Erdogan University Medical Faculty, Department of Anesthesiology and Reanimation Coordinator of this site? Confirm its status | Rize | Turkey (Türkiye) | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.