Clinical Trial Radar

Name: 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
Creator: Recep Tayyip Erdogan University
Published: 2023-07-27
License: https://www.clinicaltrials.gov/about-site/terms-conditions#availability

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	Clinical Trial NCT05960604 (PRAM-in-HYPO) for Cardiovascular Diseases, Surgery, Hypotension, Hypotension on Induction, Hypotension During Surgery is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.

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Pressure Recording Analytical Method Parameters and Their Relationship With Hypotension in Hypertensive Patients (PRAM-in-HYPO) 660

Recruiting

Clinical Trial NCT05960604 (PRAM-in-HYPO) is an observational study for Cardiovascular Diseases, Surgery, Hypotension, Hypotension on Induction, Hypotension During Surgery that is recruiting. It started on 19 February 2024 with plans to enroll 660 participants. Led by Recep Tayyip Erdogan University, it is expected to complete by 1 June 2027. The latest data from ClinicalTrials.gov was last updated on 9 April 2025.

Brief 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 propose...Show More

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 am...Show More

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

Conditions

Cardiovascular DiseasesSurgeryHypotensionHypotension on InductionHypotension During Surgery

Publications

Choudhry NK, Kronish IM, Vongpatanasin W, Ferdinand KC, Pavlik VN, Egan BM, Schoenthaler A, Houston Miller N, Hyman DJ; American Heart Association Council on Hypertension; Council on Cardiovascular and Stroke Nursing; and Council on Clinical Cardiology. Medication Adherence and Blood Pressure ...

Other Study IDs

PRAM-in-HYPO

NCT ID Number

NCT05960604

Start Date (Actual)

2024-02-19

Last Update Posted

2025-04-09

Completion Date (Estimated)

2027-06

Enrollment (Estimated)

660

Study Type

Observational

Status

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

Arms / Interventions

Participant Group/Arm

Intervention/Treatment

Low cardiac reserve/efficiency

Patients who were identified as having low cardiac reserve and efficiency, based on PRAM parameters.

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 parame...Show More

Normal cardiac reserve/efficiency

Patients who were identified as having normal cardiac reserve and efficiency, based on PRAM parameters.

Passive leg raising

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	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	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	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	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	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	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

Participation Assistant

Eligibility Criteria

Eligible Ages

Adult, Older Adult

Minimum Age

18 Years

Eligible Sexes

All

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

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

Recep Tayyip Erdogan University

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

Study Responsible Party

Başar Erdivanlı, Principal Investigator, Assoc. Prof. Başar Erdivanlı, Recep Tayyip Erdogan University

Study Central Contact

Contact: Başar Erdivanlı, Assoc. Prof., +90-505-7800730, [email protected]

5 Study Locations in 1 Countries

Turkey (Türkiye)

Gazi University Medical Faculty, Department of Anesthesiology and Reanimation, Ankara, 06560, Turkey (Türkiye)

Aycan Özdemirkan, Assoc. Prof., Contact, +90-532-7884107, [email protected]

Recruiting

Erzurum Atatürk University Medical Faculty, Department of Anesthesiology and Reanimation, Erzurum, 25240, Turkey (Türkiye)

Enes Aydın, Assoc. Prof., Contact, +90-554-3318289, [email protected]

Recruiting

Başakşehir Çam ve Sakura City Hospital, University Medical Faculty, Anesthesiology and Reanimation Clinic, Istanbul, 34480, Turkey (Türkiye)

Taner Abdullah, Asst. Prof, Contact, +90-537-5199544, [email protected]

Recruiting

Acıbadem University Medical Faculty, Department of Anesthesiology and Reanimation, Istanbul, 34755, Turkey (Türkiye)

Fevzi Toraman, Prof. Dr., Contact, +90-216-5004444, [email protected]

Recruiting

Recep Tayyip Erdogan University Medical Faculty, Department of Anesthesiology and Reanimation, Rize, 53100, Turkey (Türkiye)

Başar Erdivanlı, Assoc. Prof., Contact, +90-464-2130491, [email protected]

Not yet recruiting

Pressure Recording Analytical Method Parameters and Their Relationship With Hypotension in Hypertensive Patients (PRAM-in-HYPO) 660

Inclusion Criteria

Exclusion Criteria