Evaluating hemodynamic parameters in hypertensive patients during surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.