NCT04782154

Brief 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. Our 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
136

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 4, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

August 9, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

September 2, 2022

Status Verified

August 1, 2022

Enrollment Period

7 months

First QC Date

March 1, 2021

Last Update Submit

August 31, 2022

Conditions

Right Ventricular DysfunctionRight Heart FailureCongestive Heart Failure

Keywords

Right Ventricular Pressure Waveform

Outcome Measures

Primary Outcomes (1)

  • 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 and a RVdP/dt \< 400 mmHg.

    From thermodilution catheter insertion until 2 hours after ICU arrival

Secondary Outcomes (27)

  • Proportion of patients with difficult and complex separation from cardiopulmonary bypass at the end of cardiac surgery

    From the discontinuation of cardiopulmonary bypass until ICU arrival after surgery, assessed up to 4 hours

  • Cumulative time of Persistent Organ Dysfunction or Death (TPOD) during the first 28 days after cardiac surgery

    Up to 28 days or until hospital discharge

  • Incidence of deaths during hospitalisation

    Up to 28 days or until hospital discharge

  • Incidence of acute kidney injury (AKI)

    Up to 28 days or until hospital discharge

  • Incidence of major bleeding

    Up to 28 days or until hospital discharge

  • +22 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects ≥ 18 years of age, with planned surgery or liver transplantation, projected to receive Swan-Ganz as part of the procedure/standard of care with intermittent cardiac output measures will be screened for inclusion into the Study. Only subjects meeting all inclusion criteria will be enrolled.

You may qualify if:

  • Be ≥ 18 years of age
  • Participate in the Informed Consent process and sign/date the approved informed consent forms
  • Projected to receive Swan-Ganz catheter as part of procedure/standard of care with intermittent cardiac output and mixed venous oxygen saturation (SvO2) measures

You may not qualify if:

  • Refuse to sign consent
  • Have left bundle branch block
  • Have recurrent sepsis
  • Have hypercoagulopathy
  • Allergic to FORE-SIGHT Elite sensor adhesive
  • Latex allergy due to presence of latex in the Swan-Ganz catheter balloon.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

Location

Related Publications (16)

  • Denault AY, Couture P, Buithieu J, Haddad F, Carrier M, Babin D, Levesque S, Tardif JC. Left and right ventricular diastolic dysfunction as predictors of difficult separation from cardiopulmonary bypass. Can J Anaesth. 2006 Oct;53(10):1020-9. doi: 10.1007/BF03022532.

    PMID: 16987858BACKGROUND

  • Mehta Y, Arora D. Newer methods of cardiac output monitoring. World J Cardiol. 2014 Sep 26;6(9):1022-9. doi: 10.4330/wjc.v6.i9.1022.

    PMID: 25276302BACKGROUND

  • 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.

    PMID: 25432139BACKGROUND

  • 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.

    PMID: 27470232BACKGROUND

  • 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.

    PMID: 16798301BACKGROUND

  • Haddad F, Hunt SA, Rosenthal DN, Murphy DJ. Right ventricular function in cardiovascular disease, part I: Anatomy, physiology, aging, and functional assessment of the right ventricle. Circulation. 2008 Mar 18;117(11):1436-48. doi: 10.1161/CIRCULATIONAHA.107.653576. No abstract available.

    PMID: 18347220BACKGROUND

  • Swan HJ, Ganz W, Forrester J, Marcus H, Diamond G, Chonette D. Catheterization of the heart in man with use of a flow-directed balloon-tipped catheter. N Engl J Med. 1970 Aug 27;283(9):447-51. doi: 10.1056/NEJM197008272830902. No abstract available.

    PMID: 5434111BACKGROUND

  • Haddad F, Couture P, Tousignant C, Denault AY. The right ventricle in cardiac surgery, a perioperative perspective: II. Pathophysiology, clinical importance, and management. Anesth Analg. 2009 Feb;108(2):422-33. doi: 10.1213/ane.0b013e31818d8b92.

    PMID: 19151265BACKGROUND

  • 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.

    PMID: 28024557BACKGROUND

  • 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.

    PMID: 27467173BACKGROUND

  • 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.

    PMID: 25445946BACKGROUND

  • 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.

    PMID: 30269893BACKGROUND

  • Richard C, Monnet X, Teboul JL. Pulmonary artery catheter monitoring in 2011. Curr Opin Crit Care. 2011 Jun;17(3):296-302. doi: 10.1097/MCC.0b013e3283466b85.

    PMID: 21499096BACKGROUND

  • 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.

    PMID: 10390426BACKGROUND

  • 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.

    PMID: 20620859BACKGROUND

  • 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.

    PMID: 23623891BACKGROUND

MeSH Terms

Conditions

Ventricular Dysfunction, RightHeart Failure

Condition Hierarchy (Ancestors)

Ventricular DysfunctionHeart DiseasesCardiovascular Diseases

Study Officials

  • Andre Y Denault, MD,PhD

    Montreal Heart Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, FRCPC, ABIM-CC

Study Record Dates

First Submitted

March 1, 2021

First Posted

March 4, 2021

Study Start

August 9, 2021

Primary Completion

March 1, 2022

Study Completion

April 1, 2022

Last Updated

September 2, 2022

Record last verified: 2022-08

Locations

CA(1)