Evaluating hemodynamic parameters in hypertensive patients during surgery
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
Recep Tayyip Erdogan University · NCT05960604
This study is testing how well the heart works in people with high blood pressure during major surgeries to see if it can help predict and prevent low blood pressure during anesthesia.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 660 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Recep Tayyip Erdogan University (other) |
| Locations | 5 sites (Ankara and 4 other locations) |
| Trial ID | NCT05960604 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the relationship between cardiac reserve and efficiency in hypertensive patients undergoing major surgical procedures. Utilizing the Pressure Recording Analytical Method (PRAM), the study will evaluate hemodynamic variables to identify patients at risk of hypotension during anesthesia. The investigators will build a predictive model based on these parameters to optimize patient management and improve outcomes. The study focuses on patients with cardiovascular risk factors, including hypertension and diabetes mellitus, to understand their response to surgical stress.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who are undergoing major surgery under general anesthesia and have cardiovascular risk factors such as hypertension or diabetes.
Not a fit: Patients who refuse to consent, have significant cardiac arrhythmias, or exhibit arterial waveform distortion may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the management of hypertensive patients during surgery, potentially reducing the incidence of hypotension and improving surgical outcomes.
How similar studies have performed: While the specific application of PRAM in hypertensive patients during surgery is novel, similar studies have shown promise in using hemodynamic monitoring to predict adverse events.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Refuse to consent to the study * Arterial wave form distortion * Cardiac arrhythmia * 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 * Preoperatively receiving vasoactive drugs * Patients fitted with an intra-aortic balloon pump * Patients fitted with Extracorporeal Membrane Oxygenation * Critically ill patients requiring preoperative intensive care unit * Presence of intraabdominal hypertension * New York Heart Association Class 3-4 heart failure * Congestive heart failure with ejection fraction \< 35% * Glomerular filtration rate \< 30 ml/min/1.73 m2 * Ongoing renal replacement therapy
Where this trial is running
Ankara and 4 other locations
- Gazi University Medical Faculty, Department of Anesthesiology and Reanimation — Ankara, Turkey (Türkiye) (RECRUITING)
- Erzurum Atatürk University Medical Faculty, Department of Anesthesiology and Reanimation — Erzurum, Turkey (Türkiye) (RECRUITING)
- Başakşehir Çam ve Sakura City Hospital, University Medical Faculty, Anesthesiology and Reanimation Clinic — Istanbul, Turkey (Türkiye) (RECRUITING)
- Acıbadem University Medical Faculty, Department of Anesthesiology and Reanimation — Istanbul, Turkey (Türkiye) (RECRUITING)
- Recep Tayyip Erdogan University Medical Faculty, Department of Anesthesiology and Reanimation — Rize, Turkey (Türkiye) (NOT_YET_RECRUITING)
Study contacts
- Study coordinator: Başar Erdivanlı, Assoc. Prof.
- Email: basar.erdivanli@erdogan.edu.tr
- Phone: +90-505-7800730
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cardiovascular Diseases, Surgery, Hypotension, Hypotension on Induction, Hypotension During Surgery, Mostcare, Pressure Recording Analytical Method, Pulse contour analysis