Cardiovascular Diseases Clinical Trial
— PRAM-in-HYPOOfficial title:
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
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 | Not yet recruiting |
Enrollment | 660 |
Est. completion date | March 2025 |
Est. primary completion date | October 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Acibadem University | Istanbul | |
Turkey | Recep Tayyip Erdogan University | Rize |
Lead Sponsor | Collaborator |
---|---|
Recep Tayyip Erdogan University | Turkish Society of Thoracic and Cardio-Vascular Anesthesia and Intensive Care |
Turkey,
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* Note: There are 20 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Time to discharge from PACU | Time (hours) required for discharge from the post-anesthesia care unit. | From the end of surgery until the discharge from the post anesthesia care unit, up to 7 days | |
Other | Time to extubation | Time (hours) required for tracheal extubation. | From the end of surgery until the tracheal extubation, up to 7 days | |
Other | Time to discharge from ICU | Time (days) required for discharge from the intensive care unit. | From the end of surgery until the discharge from the intensive care unit, up to 7 days | |
Other | Time to discharge from hospital | Time (days) required for discharge from the hospital. | From the end of surgery until the discharge from the hospital, up to 7 days | |
Other | MINS7 | Myocard injury in non-cardiac surgery (MINS) during the first 7 postoperative days. | From the end of surgery until the discharge from the hospital, up to 7 days | |
Other | MACE7 | Major adverse cardiac events (MACE) during the first 7 postoperative days. | From the end of surgery until the discharge from the hospital, up to 7 days | |
Other | MAKE7 | Major adverse kidney events (MAKE) during the first 7 postoperative days. | From the end of surgery until the discharge from the hospital, up to 7 days | |
Other | Survival | Course of the patient defined as either alive, dead in ICU, or dead in hospital | From the end of surgery until the discharge from the hospital, up to 7 days | |
Other | Days out of hospital 30 | On postoperative day 30, the number of days spent outside the hospital (while being alive and free from disability) will be documented, utilizing either healthcare records or through telephone communication with the participating volunteers. | From the end of surgery until postoperative day 30 | |
Primary | Difference of mean CCE, dP/dt, SVI, CPI, Ea by hypertension and diabetes mellitus | Difference in baseline PRAM parameters between patients who have hypertension, diabetes mellitus and other cardiovascular diseases and those who have none. | From the start of surgery until the end of surgery | |
Primary | Difference of mean CCE, dP/dt, SVI, CPI, Ea at the 30th second of passive leg raising by hypertension and diabetes mellitus | Difference in the magnitude of the changes observed in PRAM parameters after a passive leg raising test between patients who have hypertension, diabetes mellitus and other cardiovascular diseases and those who have none. | From the start of passive leg raising test until the end of the test | |
Secondary | Number of Participants With Mean Arterial Blood Pressure < 65 mmHg Within 5 Minutes Following Tracheal Intubation | Hypotension, defined as mean arterial blood pressure < 65 mmHg, within 5 minutes after tracheal intubation. | From the start of surgery until the end of surgery | |
Secondary | Number of Participants With Mean Arterial Blood Pressure < 65 mmHg Between Tracheal Intubation and Surgical Incision | Hypotension, defined as mean arterial blood pressure < 65 mmHg, between 5 minutes after tracheal intubation and surgical incision. | From the start of surgery until the end of surgery | |
Secondary | Number of Participants With Mean Arterial Blood Pressure < 65 mmHg During the Surgery | Hypotension, defined as mean arterial blood pressure < 65 mmHg, between surgical incision and end of surgery. | From the start of surgery until the end of surgery | |
Secondary | Predictive factors of hypotension | Identification of patient characteristics and arterial pressure waveform parameters associated with hypotension. A multiple logistic regression analysis will be performed. | From the start of surgery until the end of surgery |
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