Pressure Recording Analytical Method Parameters and Their Relationship With Hypotension in Hypertensive Patients (PRAM-in-HYPO)

April 8, 2025 updated by: Başar Erdivanlı, Recep Tayyip Erdogan University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

660

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
      • Ankara, Turkey, 06560
        • Recruiting
        • Gazi University Medical Faculty, Department of Anesthesiology and Reanimation
        • Contact:
          • Aycan Özdemirkan, Assoc. Prof.
          • Phone Number: +90-532-7884107
          • Email: aycan.k@gmail.com
      • Erzurum, Turkey, 25240
        • Recruiting
        • Erzurum Atatürk University Medical Faculty, Department of Anesthesiology and Reanimation
        • Contact:
          • Enes Aydın, Assoc. Prof.
          • Phone Number: +90-554-3318289
          • Email: EnesMD@msn.com
      • Istanbul, Turkey, 34480
        • Recruiting
        • Başakşehir Çam ve Sakura City Hospital, University Medical Faculty, Anesthesiology and Reanimation Clinic
        • Contact:
      • Rize, Turkey, 53100
        • Not yet recruiting
        • Recep Tayyip Erdogan University Medical Faculty, Department of Anesthesiology and Reanimation
        • Contact:
      • İstanbul, Turkey, 34755
        • Recruiting
        • Acıbadem University Medical Faculty, Department of Anesthesiology and Reanimation
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who are scheduled for any major surgery will be included. Major surgery includes a broad list of cardiac surgery, thoracic surgery, hepatic surgery, pancreatic surgery, colorectal surgery, major orthopedic surgeries, cancer surgeries, where blood loss or intravascular volume loss is expected due to factors related to the patient or surgery.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Low cardiac reserve/efficiency
Patients who were identified as having low cardiac reserve and efficiency, based on PRAM parameters.
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.
Normal cardiac reserve/efficiency
Patients who were identified as having normal cardiac reserve and efficiency, based on PRAM parameters.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference of mean CCE, dP/dt, SVI, CPI, Ea by hypertension and diabetes mellitus
Time Frame: From the start of surgery until the end of surgery
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
Difference of mean CCE, dP/dt, SVI, CPI, Ea at the 30th second of passive leg raising by hypertension and diabetes mellitus
Time Frame: From the start of passive leg raising test until the end of the test
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Mean Arterial Blood Pressure < 65 mmHg Within 5 Minutes Following Tracheal Intubation
Time Frame: From the start of surgery until the end of surgery
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
Number of Participants With Mean Arterial Blood Pressure < 65 mmHg Between Tracheal Intubation and Surgical Incision
Time Frame: From the start of surgery until the end of surgery
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
Number of Participants With Mean Arterial Blood Pressure < 65 mmHg During the Surgery
Time Frame: From the start of surgery until the end of 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
Predictive factors of hypotension
Time Frame: From the start of surgery until the end of surgery
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to discharge from PACU
Time Frame: From the end of surgery until the discharge from the post anesthesia care unit, up to 7 days
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
Time to extubation
Time Frame: From the end of surgery until the tracheal extubation, up to 7 days
Time (hours) required for tracheal extubation.
From the end of surgery until the tracheal extubation, up to 7 days
Time to discharge from ICU
Time Frame: From the end of surgery until the discharge from the intensive care unit, up to 7 days
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
Time to discharge from hospital
Time Frame: From the end of surgery until the discharge from the hospital, up to 7 days
Time (days) required for discharge from the hospital.
From the end of surgery until the discharge from the hospital, up to 7 days
MINS7
Time Frame: From the end of surgery until the discharge from the hospital, up to 7 days
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
MACE7
Time Frame: From the end of surgery until the discharge from the hospital, up to 7 days
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
MAKE7
Time Frame: From the end of surgery until the discharge from the hospital, up to 7 days
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
Survival
Time Frame: From the end of surgery until the discharge from the hospital, up to 7 days
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
Days out of hospital 30
Time Frame: From the end of surgery until postoperative day 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Recep Tayyip Erdogan University

Collaborators

Turkish Society of Thoracic and Cardio-Vascular Anesthesia and Intensive Care

Investigators

  • Study Director: Fevzi Toraman, Prof., Acibadem University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 19, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

April 7, 2023

First Submitted That Met QC Criteria

July 17, 2023

First Posted (Actual)

July 27, 2023

Study Record Updates

Last Update Posted (Actual)

April 9, 2025

Last Update Submitted That Met QC Criteria

April 8, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRAM-in-HYPO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The Ethics Committee's approval is required to make individual participant data available to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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