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

Cardiovascular Diseases Clinical Trial

— PRAM-in-HYPO  

Official 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05960604
• Other study ID #: PRAM-in-HYPO
• Status: Not yet recruiting
• Start date: December 25, 2023
• Est. completion date: March 2025

Study information

• Verified date: December 2023
• Source: Recep Tayyip Erdogan University
• Contact: Basar Erdivanli, Assoc. Prof.
• Phone: +905057800730
• Email: basar.erdivanli[@]erdogan.edu.tr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

Untreated hypertension decreases the cardiac reserve through several mechanisms, which are augmented by other cardiovascular risk factors such as diabetes mellitus and coronary artery disease. Perioperative stress on top of these overlapping diseases causes wide variations in the arterial blood pressure. From the anesthesiologist's point of view, this translates into a wide variation in response to surgical stress among patients with seemingly similar cardiovascular risk factors.

The cardiac reserve may be measured by cardiac catheterization or echocardiography, none of which are feasible during a surgery. Recently, some parameters of the Pressure Recording Analytical Method (PRAM) were shown to be affected by hypertension or intraoperative events such as pneumoperitoneum and position changes. This suggests that PRAM may be used to evaluate the risk of adverse hemodynamic events in newly diagnosed, untreated hypertensive patients.

The investigators hypothesized that there is a relationship between hypertension, diabetes mellitus and decreased cardiac reserve and efficiency and that PRAM parameters may identify this. Also, the static or dynamic PRAM parameters may predict pre-incision hypotension in patients wo will undergo major surgical procedures.

In order to test these hypothesis, a prospective cohort study was planned, as the outcome has a very short latency and the intent is to observe the outcome, not to prevent or treat it. The investigators aim to collect high quality hemodynamic data from normotensive, hypertensive, and untreated hypertensive patients. In order to obtain sufficient relevant data, only patients scheduled for major surgeries will be included. Patients who are planned to be monitored with the MostCare hemodynamic monitor, and who need a passive leg raising test will be included in the study.

Hypertension is the most prevalent of cardiovascular risk factors, namely diabetes mellitus, coronary artery disease, smoking, obesity, and dyslipidemia, which may present as either the mediator or cofounder of hypertension. Therefore a detailed medical history including information relevant to these conditions will be collected.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Hypotension
• Hypotension During Surgery
• Hypotension on Induction
• Surgery

Intervention

Diagnostic Test:
• Passive leg raising
All patients who met the inclusion criteria will be placed head down flat and feet up at a 45° angle for 30 seconds. Hemodynamic parameters and analysis by pressure recording analytical method obtained with the MostCare will be collected before, during and after the test until the end of the surgery. The total duration of the intervention (passive leg raising) is 30 seconds. The total duration of hemodynamic parameters recording is expected to be 60-600 minutes.

Locations

Country	Name	City	State
Turkey	Acibadem University	Istanbul
Turkey	Recep Tayyip Erdogan University	Rize

Sponsors (2)

Lead Sponsor	Collaborator
Recep Tayyip Erdogan University	Turkish Society of Thoracic and Cardio-Vascular Anesthesia and Intensive Care

Country where clinical trial is conducted

Turkey, 

References & Publications (20)

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Siripruekpong S, Geater A, Cheewatanakornkul S. Comparison of intraoperative arterial blood pressure lability during general anaesthesia in masked, uncontrolled hypertensive and adequately controlled hypertensive patients: a prospective observational study. Anaesthesiol Intensive Ther. 2022;54(5):402-412. doi: 10.5114/ait.2022.123143. — View Citation

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* Note: There are 20 references in all — Click here to view all references

Outcome

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