Hypotension Prediction During Cardiac Surgery Postoperative Period (HPI-CCV)

Description of the Performance of a New Index for Hypotension Prediction During the Immediate Postoperative Period of Cardiac Surgery in the Intensive Care Unit

The goal of this observational study is to learn about the performance of a new index for hypotension prediction during the immediate postoperative period of cardiac surgery patients in the intensive care unit. The main questions it aims to answer are:

1. Is this new index, Hypotension Prediction Index, able to predict hypotension during the immediate postoperative period in cardiac surgery patients in the intensive care unit?
2. How frequent hypotension is during the immediate postoperative period of cardiac surgery patients in the intensive care unit? Participants will not receive any treatment beyond the usual clinical practice during the study. All patients will have an invasive arterial line that is part of the usual clinical practice. This arterial line is connected to a pressure transducer for continuous measurement of arterial pressure. A transducer equipped with the necessary technology to calculate the hypotension prediction index will be used instead of the usual transducer. An echocardiogram will be performed in every patient in the study. This test is done frequently in patients after a cardiac surgery.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Hypotension
• Intervention / Treatment: Device: Postoperative hypotension prediction index

Detailed Description

A non-interventional study will be performed, in which physiological signals will be acquired using usual clinical practice monitoring devices. These devices will be connected to catheters that are used as a routine management of the study patients. No management indication will be performed as part of the study.

The patients who accepted to participate in the study by previously signing the informed consent, will be received at the intensive care unit coming from the surgical room after a programmed cardiac surgery and once stability is ensured, investigators will proceed to connect an arterial pressure catheter that is routinely inserted into the radial artery to an Acumen IQ sensor (Edwards Lifesciences, Irvine California, USA). This sensor replaces the pressure transducer normally used in clinical practice, has similar characteristics and its use does not interfere with the usual routine. This sensor will be connected to the multiparametric monitor situated at the patient's bedside and to the Hemosphere monitoring platform (Edwards Lifesciences, Irvine California, USA). Besides being used as a pressure transducer, the Acumen IQ sensor allows for a more detailed arterial pressure signal analysis together with the Acumen Hypotension Prediction Index software. This software automatically calculates every 20 seconds the HPI, the main study parameter of this project, which as previously mentioned predicts hypotension episodes (defining hypotension as mean arterial blood pressure below 65 mmHg for at least 1 minute). Besides the HPI, the Acumen Hypotension Prediction Index software calculates complementary hemodynamic monitoring parameters that can help managing patients with different conditions among which there an be found the moderate and high risk postoperative conditions. These parameters are: stroke volume, stroke volume variation, mean arterial pressure, dP/dt (the maximal of the first derivative during the ascending phase of the arterial pressure - time curve, related to the left ventricular contractility), cardiac index, systemic vascular resistance and arterial dynamic elastance (the ratio between the pulse pressure variation and the stroke volume variation, which allows to evaluate the afterload).

The study time will be 12 hours (counting from the moment of the beginning of the patient monitoring in the intensive care unit), during which, besides the parameters calculated by the Acumen Hypotension Prediction Index, monitoring clinical and analytical routine parameters will be collected as furtherly detailed. Moreover, a transthoracic echocardiogram will be routinely performed during the first 6 hours of the patient's stay in the intensive care unit. This is a noninvasive procedure and will not interfere with the patient's usual care.

The HPI will not be shown on the monitoring platform to avoid any influence on the normal clinical practice and to be able to measure the real incidence of hypotension episodes. The complementary parameters calculated by the software will be available to the treating physician and can be used for decision making based on his criteria. The results of the echocardiogram will be available as well to the treating physician and will be interpreted and used based on treating physician criteria.

As described, besides the evaluation of the HPI performance, the results of this study will allow to have information regarding the behavior of arterial pressure in cardiac surgery postoperative patients and the creation of a protocol to reduce hypotension in these patients.

Variables

The following variables will be studied:

• Epidemiologic: age, sex, weight, height.
• Severity and risk assessment and classification systems: APACHE II, EUROSCORE II, Sequential Organ Failure Assessment Score (SOFA), Simplified Acute Physiology Score III (SAPS III)
• Risk factors: renal failure, hypertension, diabetes, dyslipidemia
• Surgery: type, total surgery time, circulatory bypass time, ischemia time
• Monitoring: HPI, arterial pressure (mean, systolic, diastolic), stroke volume variation, pulse pressure variation, dynamic arterial elastance, dP/dt, cardiac index, central venous pressure, at admission and 12h later, besides variability analysis of these parameters. Continuous arterial pressure register will be analyzed and mean arterial pressure below 65 mmHg will be determined, normalized by the monitoring time.
• Hypotension treatment: fluid bolus, vasoactive and inotropic types and doses. This management will be performed according to physician criteria.
• Echocardiographic variables: right ventricle (RV) diameter /left ventricle (LV) diameter, Tricuspid Annular Plane Systolic Excursion (TAPSE), S wave, RV/LV ratio, pulmonary artery systolic pressure (PASP) estimation, LV ejection fraction, Left Ventricular Outflow Tract Velocity Time Integral (LVOT VTI), Right Ventricular Outflow Tract Velocity Time Integral (RVOT VTI), Pulmonary Velocity Acceleration Time (PVAT), inferior vena cava (IVC) diameter.
• Mechanical ventilation at admission and 12h later: positive end expiratory pressure (PEEP), FiO2 - Fraction of inspired oxygen (FiO2), tidal volume (VT), respiratory rate, mean pressure, plateau pressure, peak pressure.
• Blood analysis: hemoglobin, leukocytes, lymphocytes, arterial blood gas parameters, renal function, ferritin, D-dimer, interleukin 6 (IL-6), peak creatin kinase (CK), creatin kinase myocardial band (CK-MB), troponin I, brain natriuretic peptide (BNP).
• Clinical results: ICU length of stay, hospital length of stay, mechanical ventilation time, vasoactive support, and mechanical ventilation. Acute kidney failure development, peak troponin I, perioperative acute myocardial infarction, mortality, stroke, evolutive SOFA, other complications (sepsis)

Data Analysis

The adequate analytic and statistical methods will be used to:

• Describe arterial pressure and complementary hemodynamic variables behavior
• Evaluate HPI performance predicting hypotension in the postoperative cardiac surgery period in the intensive care unit
• Create a predictive model for hypotension development in the cardiac surgery postoperative period
• Analyze the relationship between postoperative hypotension and complications development.

• Study Type: Observational
• Enrollment (Estimated): 41

Contacts and Locations

• Study Contact: Name: Arnoldo Santos, MD, PhD; Phone Number: 2670 0034915504800; Email: asantos@fjd.es

Study Locations

• Spain
  • Madrid, Spain, 28040
    • Recruiting
    • Intensive Care Unit. Hospital Universitario Fundación Jimenez Diaz
    • Contact: Arnoldo Santos, MD, PhD; Phone Number: 2671 915504800; Email: asantos@fjd.es
    • Contact: Jorge Llabata, MD; Phone Number: 2671 915504800; Email: jorge.llabata@quironsalud.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients in the postoperative period of programmed cardiac surgery, who are admitted to the intensive care unit after the surgery. according to inverstigator and Hemosphere monitor disponibilty

Description

Inclusion Criteria:

• age ≥ 18 y.o.
• Programmed cardiac surgery
• Hemosphere platform availability
• Signed informed consent

Exclusion Criteria:

• Need for circulatory or respiratory mechanical assistance device support
• Urgent/emergent surgery

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cardiac Surgery Postoperative Patients; Cardiac Surgery Postoperative Patients who are admitted to the intensive care unit after the surgery, from the surgical room	Device: Postoperative hypotension prediction index; Performance of the hypotension prediction index (HPI) in predicting hypotension episodes in the first 12 h of cardiac surgery postoperative

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HPI Performance on Hypotension Prediction	Area Under the Receiver Operator Characteristic (ROC) curve for hypotension prediction, defining hypotension as mean arterial blood pressure below 65 mmHg for at least 1 minute.	First 12 hours of the cardiac surgery postoperative period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hypotension incidence	Hypotension incidence	First 12 hours of the cardiac surgery postoperative period
Hypotension consequences: acute kidney injury	Development of Acute kidney injury described as an increase in Serum Creatinine (SCr) by ⩾0.3 mg/dl (⩾26.5 μmol/l) within 48 hours or Increase in SCr to ⩾1.5 times baseline, which is known or presumed to have occurred within the prior 7 days; or Urine volume <0.5 ml/kg/h for 6 hours, as well as maximum creatinine levels.	Up to two months after surgery
Hypotension consequences: myocardial injury	Development of complications related with hypotension such as myocardial injury. Dynamics of Troponin I levels will be studied, baseline at ICU admission, peak levels, dynamics during the first 12h hours of admission up to the first 7 days of ICU admission.	First 7 days of ICU admission
Hypotension consequences: prolonged mechanical ventilation	Development of complications related with hypotension such as prolonged mechanical ventilation defined as more than 21 days of mechanical ventilation.	Mechanical ventilation free days at 2 months
Actions performed for hypotension management: vasopressors and inotropic drugs	Administration of noradrenaline, dobutamine, levosimendan and vasopressin accumulated dosis and maximum dosis	First 12 hours of the cardiac surgery postoperative period
Actions performed for hypotension management: fluid therapy	Description and quantification of actions performed for hypotension management such fluid therapy type and dose in ml/h.	First 12 hours of the cardiac surgery postoperative period
General outcomes: Intensive care unit and hospital length of stay	The intensive care unit length of stay (days) and hospital length of stay (days) will be studied	Up tp two months after surgery
General outcomes: mortality	Mortality (binary variable, alive or dead) will be studied	Up to two months after surgery
General outcomes: respiratory failure	Respiratory failure development will be studied defined as failure to wean from mechanical ventilation within 48 hours of surgery or unplanned intubation/reintubation postoperatively.	Up to two months after surgery
General outcomes: nosocomial infections	Nosocomial infections development will be studied, defined as an infection acquired during the process of receiving health care that was not present during the time of admission.	Up to two months after surgery
General outcomes: reintervention	Need for cardiac surgery reintervention (binary variable)	First 48 hours of the cardiac surgery postoperative period

Collaborators and Investigators

• Sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Publications and helpful links

General Publications

• Fischer GW, Levin MA. Vasoplegia during cardiac surgery: current concepts and management. Semin Thorac Cardiovasc Surg. 2010 Summer;22(2):140-4. doi: 10.1053/j.semtcvs.2010.09.007.
• Hatib F, Jian Z, Buddi S, Lee C, Settels J, Sibert K, Rinehart J, Cannesson M. Machine-learning Algorithm to Predict Hypotension Based on High-fidelity Arterial Pressure Waveform Analysis. Anesthesiology. 2018 Oct;129(4):663-674. doi: 10.1097/ALN.0000000000002300.
• Wijnberge M, Geerts BF, Hol L, Lemmers N, Mulder MP, Berge P, Schenk J, Terwindt LE, Hollmann MW, Vlaar AP, Veelo DP. Effect of a Machine Learning-Derived Early Warning System for Intraoperative Hypotension vs Standard Care on Depth and Duration of Intraoperative Hypotension During Elective Noncardiac Surgery: The HYPE Randomized Clinical Trial. JAMA. 2020 Mar 17;323(11):1052-1060. doi: 10.1001/jama.2020.0592.
• Meng L, Yu W, Wang T, Zhang L, Heerdt PM, Gelb AW. Blood Pressure Targets in Perioperative Care. Hypertension. 2018 Oct;72(4):806-817. doi: 10.1161/HYPERTENSIONAHA.118.11688. No abstract available.
• Guarracino F, Habicher M, Treskatsch S, Sander M, Szekely A, Paternoster G, Salvi L, Lysenko L, Gaudard P, Giannakopoulos P, Kilger E, Rompola A, Haberle H, Knotzer J, Schirmer U, Fellahi JL, Hajjar LA, Kettner S, Groesdonk HV, Heringlake M. Vasopressor Therapy in Cardiac Surgery-An Experts' Consensus Statement. J Cardiothorac Vasc Anesth. 2021 Apr;35(4):1018-1029. doi: 10.1053/j.jvca.2020.11.032. Epub 2020 Nov 19.
• Levin MA, Lin HM, Castillo JG, Adams DH, Reich DL, Fischer GW. Early on-cardiopulmonary bypass hypotension and other factors associated with vasoplegic syndrome. Circulation. 2009 Oct 27;120(17):1664-71. doi: 10.1161/CIRCULATIONAHA.108.814533. Epub 2009 Oct 12.
• Ouattara A, Boccara G, Kockler U, Lecomte P, Leprince P, Leger P, Riou B, Rama A, Coriat P. Remifentanil induces systemic arterial vasodilation in humans with a total artificial heart. Anesthesiology. 2004 Mar;100(3):602-7. doi: 10.1097/00000542-200403000-00021.
• Kotani Y, Yoshida T, Kumasawa J, Kamei J, Taguchi A, Kido K, Yamaguchi N, Kariya T, Nakasone M, Mikami N, Koga T, Nakayama I, Shibata M, Yoshida T, Nashiki H, Karatsu S, Nogi K, Tokuhira N, Izawa J. The impact of relative hypotension on acute kidney injury progression after cardiac surgery: a multicenter retrospective cohort study. Ann Intensive Care. 2021 Dec 20;11(1):178. doi: 10.1186/s13613-021-00969-4.
• de la Hoz MA, Rangasamy V, Bastos AB, Xu X, Novack V, Saugel B, Subramaniam B. Intraoperative Hypotension and Acute Kidney Injury, Stroke, and Mortality during and outside Cardiopulmonary Bypass: A Retrospective Observational Cohort Study. Anesthesiology. 2022 Jun 1;136(6):927-939. doi: 10.1097/ALN.0000000000004175.
• Weis F, Kilger E, Beiras-Fernandez A, Nassau K, Reuter D, Goetz A, Lamm P, Reindl L, Briegel J. Association between vasopressor dependence and early outcome in patients after cardiac surgery. Anaesthesia. 2006 Oct;61(10):938-42. doi: 10.1111/j.1365-2044.2006.04779.x.
• Parke RL, McGuinness SP, Gilder E, McCarthy LW. Intravenous fluid use after cardiac surgery: a multicentre, prospective, observational study. Crit Care Resusc. 2014 Sep;16(3):164-9.
• Davies SJ, Vistisen ST, Jian Z, Hatib F, Scheeren TWL. Ability of an Arterial Waveform Analysis-Derived Hypotension Prediction Index to Predict Future Hypotensive Events in Surgical Patients. Anesth Analg. 2020 Feb;130(2):352-359. doi: 10.1213/ANE.0000000000004121. Erratum In: Anesth Analg. 2023 Sep 1;137(3):e33.

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2023
• Primary Completion (Estimated): January 31, 2024
• Study Completion (Estimated): March 30, 2024

Study Registration Dates

• First Submitted: February 22, 2023
• First Submitted That Met QC Criteria: April 22, 2023
• First Posted (Actual): May 3, 2023

Study Record Updates

• Last Update Posted (Actual): November 14, 2023
• Last Update Submitted That Met QC Criteria: November 13, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: cardiac surgery; postoperative period; hypotension prediction index
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension
• Other Study ID Numbers: PIC146-22_FJD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: In this study exists a potential generation of intellectual property generation.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No