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Search / Trial NCT05960604

Pressure Recording Analytical Method Parameters and Their Relationship With Hypotension in Hypertensive Patients

Launched by RECEP TAYYIP ERDOGAN UNIVERSITY · Jul 17, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Mostcare Pressure Recording Analytical Method Pulse Contour Analysis Hemodynamic Monitoring Effective Arterial Elastance Cardiac Cycle Efficiency Cardiac Power Output Myocardial Contraction Cardiac Output Stroke Volume Systemic Vascular Resistance

ClinConnect Summary

This clinical trial, called PRAM-in-HYPO, is looking at how certain measurements of heart function can help doctors understand and predict low blood pressure (hypotension) in patients with high blood pressure (hypertension) who are undergoing major surgeries. The researchers want to see if using advanced monitoring technology can help identify patients at risk for low blood pressure after they receive anesthesia. This is important because low blood pressure during surgery can lead to complications.

To participate in this study, you need to be at least 18 years old, be scheduled for major surgery lasting more than two hours, and have a longer expected recovery time. Participants will be closely monitored using special equipment to measure their heart function and blood pressure during the surgery. However, individuals with certain heart or kidney conditions, or those who are critically ill, cannot take part in this trial. If you are eligible and decide to join, you will have the chance to help improve care for future surgical patients by contributing to valuable research.

Gender

ALL

Eligibility 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

About Recep Tayyip Erdogan University

Recep Tayyip Erdogan University is a prominent academic institution committed to advancing healthcare through innovative research and clinical trials. Located in Turkey, the university fosters a collaborative environment that integrates cutting-edge science with clinical practice. With a focus on enhancing patient care and contributing to medical knowledge, the university actively engages in diverse clinical research initiatives aimed at addressing pressing health challenges. Its multidisciplinary approach ensures rigorous study design and ethical standards, positioning the institution as a key player in the advancement of medical research and education in the region.

Locations

Rize, , Turkey

İstanbul, , Turkey

Rize, , Turkey

Ankara, , Turkey

Erzurum, , Turkey

Istanbul, , Turkey

İstanbul, , Turkey

Patients applied

0 patients applied

Trial Officials

Fevzi Toraman, Prof.

Study Director

Acibadem University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported