Right Ventricular Pressure Waveform Monitoring in Cardiac Surgery

Congestive Heart Failure Clinical Trial

— PACEPORT  

Official title:

Early Identification and Prediction of Right Ventricular Dysfunction and Failure in Critically Ill Patients: An Observational Non-Interventional Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04092855
• Other study ID #: 2019-2527
• Status: Recruiting
• Start date: December 10, 2018
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: Montreal Heart Institute
• Contact: Sophie Robichaud, RRT
• Phone: 5143763330
• Email: sophie.robichaud[@]icm-mhi.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

RV dysfunction has been associated with increased mortality in the ICU and cardiac surgical patients. Thus, early identification of RV dysfunction at less severe stages will allow for earlier intervention and potentially better patient outcomes.

However, so far, no studies have reported prospectively the prevalence of abnormal RV pressure waveform during cardiac surgery and in the ICU. The investigator's primary hypothesis is that the prevalence of abnormal RV pressure waveform occurs in more than 50% of cardiac surgical patients throughout their hospitalization. Those patients with abnormal RV pressure waveform will be more prone to post-operative complications related to RV dysfunction and failure in the OR and ICU.

Description:

Right ventricular (RV) dysfunction is mostly associated to a decrease in contractility, right ventricular pressure overload or right ventricular volume overload. RV dysfunction can occur in a number of clinical scenarios in the intensive care unit (ICU) and operating room (OR): pulmonary embolism, acute respiratory distress syndrome (ARDS), septic shock, RV infarction, and in pulmonary hypertensive patients undergoing cardiac surgery.

Unfortunately, identifying which patients will develop RV dysfunction and then progress towards RV failure have proven difficult. One of the reasons for delaying the diagnosis of RV dysfunction could be the lack of uniform definition, especially in the perioperative period. Echocardiographic definitions of RV dysfunction have been described: RV fractional area change (RVFAC) < 35 %, tricuspid annular plane systolic excursion (TAPSE) < 16 mm, tissue Doppler S wave velocity <10 cm/s, RV ejection fraction (RVEF) <45% and RV dilation. However, echocardiographic indices alone are insufficient in describing RV function. The diagnosis of fulminant RV failure is more easily recognised as a combination of echocardiographic measures, compromised hemodynamic measures and clinical presentation. RV dysfunction is inevitably associated with absolute or relative pulmonary hypertension because of the anatomic and physiological connection between the RV and pulmonary vascular system. The gold standard for measuring pulmonary pressure is still the pulmonary artery catheter. However, RV output can initially be preserved despite of pulmonary hypertension. It is therefore mandatory that early, objective, continuous, easily obtainable and subclinical indices of RV dysfunction are found and validated to initiate early treatment of this disease.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 112
• Est. completion date: December 31, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

-Male or female patients, age 18 and older, undergoing cardiac surgery and receiving standard of care monitoring utilizing a pulmonary artery catheter.

Exclusion Criteria:

• Emergency surgery or inability to obtain consent

• Concomitant diseases such as pericardial constriction, congenital heart disease, severe valvular regurgitation, right ventricular systolic dysfunction, or right ventricular infarction.

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure
• Right Heart Failure
• Right Ventricular Dysfunction
• Ventricular Dysfunction
• Ventricular Dysfunction, Right

Locations

Country	Name	City	State
Canada	Montreal Heart Institute	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Montreal Heart Institute	Edwards Lifesciences

Country where clinical trial is conducted

Canada, 

References & Publications (25)

Ait-Oufella H, Bourcier S, Alves M, Galbois A, Baudel JL, Margetis D, Bige N, Offenstadt G, Maury E, Guidet B. Alteration of skin perfusion in mottling area during septic shock. Ann Intensive Care. 2013 Sep 16;3(1):31. doi: 10.1186/2110-5820-3-31. — View Citation

Amsallem M, Kuznetsova T, Hanneman K, Denault A, Haddad F. Right heart imaging in patients with heart failure: a tale of two ventricles. Curr Opin Cardiol. 2016 Sep;31(5):469-82. doi: 10.1097/HCO.0000000000000315. — View Citation

Beaubien-Souligny W, Benkreira A, Robillard P, Bouabdallaoui N, Chasse M, Desjardins G, Lamarche Y, White M, Bouchard J, Denault A. Alterations in Portal Vein Flow and Intrarenal Venous Flow Are Associated With Acute Kidney Injury After Cardiac Surgery: A Prospective Observational Cohort Study. J Am Heart Assoc. 2018 Oct 2;7(19):e009961. doi: 10.1161/JAHA.118.009961. — View Citation

Bergeron N, Dubois MJ, Dumont M, Dial S, Skrobik Y. Intensive Care Delirium Screening Checklist: evaluation of a new screening tool. Intensive Care Med. 2001 May;27(5):859-64. doi: 10.1007/s001340100909. — View Citation

Denault A, Lamarche Y, Rochon A, Cogan J, Liszkowski M, Lebon JS, Ayoub C, Taillefer J, Blain R, Viens C, Couture P, Deschamps A. Innovative approaches in the perioperative care of the cardiac surgical patient in the operating room and intensive care unit. Can J Cardiol. 2014 Dec;30(12 Suppl):S459-77. doi: 10.1016/j.cjca.2014.09.029. Epub 2014 Oct 5. — View Citation

Denault AY, Bussières J, Carrier M, Mathieu P, and the DSBSG. The importance of difficult separation from cardiopulmonary bypass: the Montreal and Quebec Heart Institute experience. Exp Clin Cardiol. 2006;11 (1):37.

Denault AY, Bussieres JS, Arellano R, Finegan B, Gavra P, Haddad F, Nguyen AQN, Varin F, Fortier A, Levesque S, Shi Y, Elmi-Sarabi M, Tardif JC, Perrault LP, Lambert J. A multicentre randomized-controlled trial of inhaled milrinone in high-risk cardiac surgical patients. Can J Anaesth. 2016 Oct;63(10):1140-1153. doi: 10.1007/s12630-016-0709-8. Epub 2016 Jul 28. — View Citation

Denault AY, Chaput M, Couture P, Hebert Y, Haddad F, Tardif JC. Dynamic right ventricular outflow tract obstruction in cardiac surgery. J Thorac Cardiovasc Surg. 2006 Jul;132(1):43-9. doi: 10.1016/j.jtcvs.2006.03.014. — View Citation

Denault AY, Pearl RG, Michler RE, Rao V, Tsui SS, Seitelberger R, Cromie M, Lindberg E, D'Armini AM. Tezosentan and right ventricular failure in patients with pulmonary hypertension undergoing cardiac surgery: the TACTICS trial. J Cardiothorac Vasc Anesth. 2013 Dec;27(6):1212-7. doi: 10.1053/j.jvca.2013.01.023. Epub 2013 Mar 21. — View Citation

Haddad F, Couture P, Tousignant C, Denault AY. The right ventricle in cardiac surgery, a perioperative perspective: I. Anatomy, physiology, and assessment. Anesth Analg. 2009 Feb;108(2):407-21. doi: 10.1213/ane.0b013e31818f8623. — View Citation

Haddad F, Doyle R, Murphy DJ, Hunt SA. Right ventricular function in cardiovascular disease, part II: pathophysiology, clinical importance, and management of right ventricular failure. Circulation. 2008 Apr 1;117(13):1717-31. doi: 10.1161/CIRCULATIONAHA.107.653584. No abstract available. — View Citation

Hrymak C, Strumpher J, Jacobsohn E. Acute Right Ventricle Failure in the Intensive Care Unit: Assessment and Management. Can J Cardiol. 2017 Jan;33(1):61-71. doi: 10.1016/j.cjca.2016.10.030. Epub 2016 Nov 11. — View Citation

Inouye SK, van Dyck CH, Alessi CA, Balkin S, Siegal AP, Horwitz RI. Clarifying confusion: the confusion assessment method. A new method for detection of delirium. Ann Intern Med. 1990 Dec 15;113(12):941-8. doi: 10.7326/0003-4819-113-12-941. — View Citation

Kellum JA, Lameire N; KDIGO AKI Guideline Work Group. Diagnosis, evaluation, and management of acute kidney injury: a KDIGO summary (Part 1). Crit Care. 2013 Feb 4;17(1):204. doi: 10.1186/cc11454. — View Citation

Korshin A, Gronlykke L, Nilsson JC, Moller-Sorensen H, Ihlemann N, Kjoller M, Damgaard S, Lehnert P, Hassager C, Kjaergaard J, Ravn HB. The feasibility of tricuspid annular plane systolic excursion performed by transesophageal echocardiography throughout heart surgery and its interchangeability with transthoracic echocardiography. Int J Cardiovasc Imaging. 2018 Jul;34(7):1017-1028. doi: 10.1007/s10554-018-1306-4. Epub 2018 Jan 30. — View Citation

Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, Kaul S, Wiviott SD, Menon V, Nikolsky E, Serebruany V, Valgimigli M, Vranckx P, Taggart D, Sabik JF, Cutlip DE, Krucoff MW, Ohman EM, Steg PG, White H. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation. 2011 Jun 14;123(23):2736-47. doi: 10.1161/CIRCULATIONAHA.110.009449. No abstract available. — View Citation

Naeije R, Manes A. The right ventricle in pulmonary arterial hypertension. Eur Respir Rev. 2014 Dec;23(134):476-87. doi: 10.1183/09059180.00007414. — View Citation

Raymond M, Gronlykke L, Couture EJ, Desjardins G, Cogan J, Cloutier J, Lamarche Y, L'Allier PL, Ravn HB, Couture P, Deschamps A, Chamberland ME, Ayoub C, Lebon JS, Julien M, Taillefer J, Rochon A, Denault AY. Perioperative Right Ventricular Pressure Monitoring in Cardiac Surgery. J Cardiothorac Vasc Anesth. 2019 Apr;33(4):1090-1104. doi: 10.1053/j.jvca.2018.08.198. Epub 2018 Aug 25. — View Citation

Rubenfeld GD, Angus DC, Pinsky MR, Curtis JR, Connors AF Jr, Bernard GR. Outcomes research in critical care: results of the American Thoracic Society Critical Care Assembly Workshop on Outcomes Research. The Members of the Outcomes Research Workshop. Am J Respir Crit Care Med. 1999 Jul;160(1):358-67. doi: 10.1164/ajrccm.160.1.9807118. No abstract available. — View Citation

Rudski LG, Lai WW, Afilalo J, Hua L, Handschumacher MD, Chandrasekaran K, Solomon SD, Louie EK, Schiller NB. Guidelines for the echocardiographic assessment of the right heart in adults: a report from the American Society of Echocardiography endorsed by the European Association of Echocardiography, a registered branch of the European Society of Cardiology, and the Canadian Society of Echocardiography. J Am Soc Echocardiogr. 2010 Jul;23(7):685-713; quiz 786-8. doi: 10.1016/j.echo.2010.05.010. No abstract available. — View Citation

Shahian DM, O'Brien SM, Filardo G, Ferraris VA, Haan CK, Rich JB, Normand SL, DeLong ER, Shewan CM, Dokholyan RS, Peterson ED, Edwards FH, Anderson RP; Society of Thoracic Surgeons Quality Measurement Task Force. The Society of Thoracic Surgeons 2008 cardiac surgery risk models: part 1--coronary artery bypass grafting surgery. Ann Thorac Surg. 2009 Jul;88(1 Suppl):S2-22. doi: 10.1016/j.athoracsur.2009.05.053. — View Citation

St-Pierre P, Deschamps A, Cartier R, Basmadjian AJ, Denault AY. Inhaled milrinone and epoprostenol in a patient with severe pulmonary hypertension, right ventricular failure, and reduced baseline brain saturation value from a left atrial myxoma. J Cardiothorac Vasc Anesth. 2014 Jun;28(3):723-9. doi: 10.1053/j.jvca.2012.10.017. Epub 2013 Apr 26. No abstract available. — View Citation

Stoppe C, McDonald B, Benstoem C, Elke G, Meybohm P, Whitlock R, Fremes S, Fowler R, Lamarche Y, Jiang X, Day AG, Heyland DK. Evaluation of Persistent Organ Dysfunction Plus Death As a Novel Composite Outcome in Cardiac Surgical Patients. J Cardiothorac Vasc Anesth. 2016 Jan;30(1):30-8. doi: 10.1053/j.jvca.2015.07.035. Epub 2015 Jul 29. — View Citation

Sun LY, Chung AM, Farkouh ME, van Diepen S, Weinberger J, Bourke M, Ruel M. Defining an Intraoperative Hypotension Threshold in Association with Stroke in Cardiac Surgery. Anesthesiology. 2018 Sep;129(3):440-447. doi: 10.1097/ALN.0000000000002298. Erratum In: Anesthesiology. 2019 Feb;130(2):360. — View Citation

Vieillard-Baron A, Naeije R, Haddad F, Bogaard HJ, Bull TM, Fletcher N, Lahm T, Magder S, Orde S, Schmidt G, Pinsky MR. Diagnostic workup, etiologies and management of acute right ventricle failure : A state-of-the-art paper. Intensive Care Med. 2018 Jun;44(6):774-790. doi: 10.1007/s00134-018-5172-2. Epub 2018 May 9. — View Citation

* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of abnormal diastolic RV waveforms before CPB, after CPB and in the ICU	Abnormal RV pressure waveform will be defined as a difference between the RV end-diastolic minus the early-diastolic pressure > 4 mmHg.	From thermodilution catheter insertion until 2 hours after ICU arrival
Secondary	Proportion of patients with difficult and complex separation from cardiopulmonary bypass at the end of cardiac surgery	Difficult separation from cardiopulmonary bypass: instability requiring at least two different types of pharmacological agents (i.e., inotropes ± vasopressors ± inhaled agents) Complex separation from cardiopulmonary bypass: Hemodynamic instability requiring return on cardiopulmonary bypass or addition of mechanical support (intra-aortic balloon pump or extra-corporeal membrane oxygenator)	From the discontinuation of cardiopulmonary bypass until ICU arrival after surgery, assessed up to 4 hours.
Secondary	Cumulative time of Persistent Organ Dysfunction or Death (TPOD) during the first 28 days after cardiac surgery	TPOD is a continuous variable representative of the burden of care and morbidity during the first 28 days following cardiac surgery and was chosen to circumvent issues arising for using other clinical endpoint such as ICU length of stay	Up to 28 days or until hospital discharge
Secondary	Incidence of deaths during hospitalisation	Death from any cause	Up to 30 days or until hospital discharge
Secondary	Incidence of acute kidney injury (AKI)	Acute kidney injury (AKI) according to KDIGO serum creatinine criteria: Stage 1: =50% or 27 umol/L increases in serum creatinine, Stage 2: =100% increase in serum creatinine, Stage 3 =200% increase in serum creatinine or an increase to a level of =254 umol/L or dialysis initiation.	Up to 28 days or until hospital discharge
Secondary	Incidence of major bleeding	Major bleeding is defined by the Bleeding Academic Research Consortium (BARC) as one of the following: Perioperative intracranial bleeding within 48h; Reoperation after closure of sternotomy for the purpose of controlling bleeding; Transfusion of =5 units of whole blood of packed red blood cells within a 48 hours period; Chest tube output =2L within a 24 hours period	Up to 28 days or until hospital discharge
Secondary	Incidence of surgical reintervention for any reasons	Re-operation after the initial surgery for any cause	Up to 28 days or until hospital discharge
Secondary	Incidence of deep sternal wound infection or mediastinitis	Diagnosis of a deep incisional surgical site infection or mediastinitis by a surgeon or attending physician	Up to 28 days or until hospital discharge
Secondary	Incidence of delirium	Delirium is defined as an intensive care delirium screening checklist (ICDSC) score(18) of =4 in the week following surgery or positive result for the Confusion Assessment Method for the ICU (CAM-ICU).	Up to 28 days or until hospital discharge
Secondary	Incidence of stroke	Central neurologic deficit persisting longer than 72 hours	Up to 28 days or until hospital discharge
Secondary	Total duration of ICU stay in hours	Number of hours passed in the ICU	Up to 28 days or until hospital discharge
Secondary	Duration of vasopressor requirements (in hours)	Vasopressors include norepinephrine, epinephrine, dobutamine, vasopressin, phenylephrine, milrinone, isoproterenol and dopamine.	Up to 28 days or until hospital discharge
Secondary	Duration of hospital stay (in days)	Number of days hospitalized from the day of surgery to discharge	Up to 28 days or until hospital discharge
Secondary	Duration of mechanical ventilation (in hours)	A duration of >24 hours will be considered prolonged ventilation requirements.	Up to 28 days or until hospital discharge
Secondary	Incidence of major morbidity or mortality	Including death, prolonged ventilation, stroke, renal failure (Stage =2), deep sternal wound infection and reoperation for any reason.	Up to 28 days or until hospital discharge
Secondary	Right ventricular ejection fraction	Assessed by the American Society of Echocardiography guidelines	From arrival to the operating room until 2 hours after ICU arrival
Secondary	Right ventricular fractional area change	Assessed by the American Society of Echocardiography guidelines	From arrival to the operating room until 2 hours after ICU arrival
Secondary	Right ventricular strain	Assessed by the American Society of Echocardiography guidelines	From arrival to the operating room until 2 hours after ICU arrival
Secondary	Tricuspid annular plane systolic excursion	Assessed by the American Society of Echocardiography guidelines	From arrival to the operating room until 2 hours after ICU arrival
Secondary	Right ventricular performance index	Assessed by the American Society of Echocardiography guidelines	From arrival to the operating room until 2 hours after ICU arrival
Secondary	Portal flow pulsatility fraction	Defined as the difference between the maximal and the minimal velocity during the cardiac cycle divided by the maximal velocity	From arrival to the operating room until 2 hours after ICU arrival
Secondary	Right ventricular stroke work index	0.0136x Stroke volume index x (Mean pulmonary artery pressure-mean right atrial pressure)	From arrival to the operating room until 2 hours after ICU arrival
Secondary	Relative pulmonary pressure	The ratio of the mean systemic arterial pressure divided by the mean pulmonary artery pressure	From arrival to the operating room until 2 hours after ICU arrival
Secondary	Right ventricular function index	Defined as (isovolumic contraction time + isovolumic relaxation time)/RV ejection time	From arrival to the operating room until 2 hours after ICU arrival
Secondary	Pulmonary artery pulsatility index (PAPi)	Defined as (systolic pulmonary artery pressure - diastolic pulmonary artery pressure)/central venous pressure]	From arrival to the operating room until 2 hours after ICU arrival
Secondary	Compliance of the pulmonary artery (CPA)	Stroke volume divided by the pulmonary artery pulse pressure (systolic minus the diastolic pulmonary artery pressure)	From arrival to the operating room until 2 hours after ICU arrival
Secondary	Pulsatility of femoral venous flow	Velocity variations of blood flow in the femoral vein during the cardiac cycle	From arrival to the operating room until 2 hours after ICU arrival