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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:
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:
Data Analysis
The adequate analytic and statistical methods will be used to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cardiac Surgery Postoperative Patients | Cardiac Surgery Postoperative Patients who are admitted to the intensive care unit after the surgery, from the surgical room |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Postoperative hypotension prediction index | Device | Performance of the hypotension prediction index (HPI) in predicting hypotension episodes in the first 12 h of cardiac surgery postoperative |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Arnoldo Santos, MD, PhD | Contact | 0034915504800 | 2670 | asantos@fjd.es |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Intensive Care Unit. Hospital Universitario Fundación Jimenez Diaz | Recruiting | Madrid | 28040 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33334651 | Background | 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. | |
| 21092891 |
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In this study exists a potential generation of intellectual property generation.
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| 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 |
| Background |
| 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. |
| 19822810 | Background | 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. |
| 15108975 | Background | 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. |
| 34928430 | Background | 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. |
| 35188970 | Background | 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. |
| 16978306 | Background | 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. |
| 25161017 | Background | 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. |
| 30354725 | Background | 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. |
| 29894315 | Background | 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. |
| 30896602 | Background | 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. |
| 32065827 | Background | 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. |