We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Right Ventricular Echocardiography in caRdiac SurgEry (ReVERSE)

This study is currently recruiting participants.
Verified September 2017 by Lars Grønlykke, Rigshospitalet, Denmark
Sponsor:
ClinicalTrials.gov Identifier:
NCT03301571
First Posted: October 4, 2017
Last Update Posted: October 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Lars Grønlykke, Rigshospitalet, Denmark
  Purpose

Postoperative right ventricular (RV) dysfunction increases mortality and risk of cardiac failure after cardiac surgery substantially. A comprehensive understanding of this condition is paramount in order to achieve success in treatment and early diagnosis.

This study has two main aims.

Perioperative aim:

To investigate correlations between changes in echocardiographic measurements and hemodynamic changes at baseline and following coronary artery bypass graft (CABG) surgery.

Postoperative aim:

To evaluate changes in haemodynamics and echocardiographic parameters during separate physiological interventions (increase in preload/afterload, oxygen fraction, pacing modes (AAI/DDD/VVI)).


Condition Intervention
Right Ventricular Dysfunction Other: Change in preload and afterload Other: Inspired oxygen Other: Pacemaker mode

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Intervention Model Description:
All patients will receive the same interventions
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Response in Right Ventricular Function to Change in Afterload, Preload and Inspired Oxygen in Patients Undergoing Coronary Artery Bypass Graft Surgery

Resource links provided by NLM:


Further study details as provided by Lars Grønlykke, Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Change in right ventricular function during CABG assessed with TAPSE [ Time Frame: During a standard CABG operation ]
    Assessing the change in RV function during CABG surgery


Secondary Outcome Measures:
  • Right ventricular function assessed with TAPSE after each intervention [ Time Frame: Immediate postoperative period ]
    Change in TAPSE after each intervention

  • Change in cardiac output measured with Swan-Ganz during CABG [ Time Frame: During a standard CABG operation ]
    Cardiac output measured with the thermodilution technique

  • Change in cardiac output measured with Swan-Ganz after each intervention [ Time Frame: Immediate postoperative period ]
    Cardiac output measured with the thermodilution technique

  • Response in right ventricular function parameter S' to each intervention [ Time Frame: Immediate postoperative period ]
    Change in S'

  • Response in right ventricular function parameter S' during CABG [ Time Frame: During a standard CABG operation ]
    Change in S'

  • Response in right ventricular function parameter Tei index to each intervention [ Time Frame: Immediate postoperative period ]
    Change in Tei index

  • Response in right ventricular function parameter Tei index during a standard CABG operation [ Time Frame: During a standard CABG operation ]
    Change in Tei index

  • Response in right ventricular function parameter RVFAC to each intervention [ Time Frame: Immediate postoperative period ]
    Change in RVFAC

  • Response in right ventricular function parameter RVFAC during a standard CABG operation [ Time Frame: During a standard CABG operation ]
    Change in RVFAC

  • Response in left ventricular function parameter MAPSE to each intervention [ Time Frame: Immediate postoperative period ]
    Change in MAPSE

  • Response in left ventricular function parameter MAPSE during a standard CABG operation [ Time Frame: During a standard CABG operation ]
    Change in MAPSE

  • Response in right ventricular function parameter strain % to each intervention [ Time Frame: Immediate postoperative period ]
    Change in strain %

  • Response in right ventricular function parameter strain % during a standard CABG operation [ Time Frame: During a standard CABG operation ]
    Change in strain %

  • Response in right ventricular function parameter strain rate to each intervention [ Time Frame: Immediate postoperative period ]
    Change in strain rate

  • Response in right ventricular function parameter strain rate during a standard CABG operation [ Time Frame: During a standard CABG operation ]
    Change in strain rate

  • Response in right ventricular function parameter RV size to each intervention [ Time Frame: Immediate postoperative period ]
    Change in RV size

  • Response in right ventricular function parameter RV size during a standard CABG operation [ Time Frame: During a standard CABG operation ]
    Change in RV size

  • Response in right ventricular function parameter pulmonary artery flow velocity to each intervention [ Time Frame: Immediate postoperative period ]
    Change in flow velocity in pulmonary artery

  • Response in right ventricular function parameter pulmonary artery flow velocity during a standard CABG operation [ Time Frame: During a standard CABG operation ]
    Change in flow velocity in pulmonary artery

  • Response in right ventricular function parameter RVEF to each intervention [ Time Frame: Immediate postoperative period ]
    Change in RVEF measured with 3D echo

  • Response in right ventricular function parameter RVEF during a standard CABG operation [ Time Frame: During a standard CABG operation ]
    Change in RVEF measured with 3D echo

  • Response in right ventricular function parameter RVEF during CABG [ Time Frame: Immediate postoperative period ]
    Change in RVEF measured with 3D echo

  • Change in cardiac output measured with Swan Ganz in response during a standard CABG operation [ Time Frame: During a standard CABG operation ]
    Following each intervention in the postoperative period cardiac output will be measured with the thermodilution technique.

  • Change in cardiac output measured with Swan Ganz in response to each intervention [ Time Frame: Immediate postoperative period ]
    Following each intervention in the postoperative period cardiac output will be measured with the thermodilution technique.

  • Change in hemodynamic pressures in response to each intervention [ Time Frame: Immediate postoperative period ]
    Following each intervention in the postoperative period hemodynamic pressures will be measured with the Swan Ganz catheter

  • Change in hemodynamic pressures during a standard CABG operation [ Time Frame: During a standard CABG operation ]
    Following each intervention in the postoperative period hemodynamic pressures will be measured with the Swan Ganz catheter


Estimated Enrollment: 30
Actual Study Start Date: May 1, 2017
Estimated Study Completion Date: January 1, 2019
Estimated Primary Completion Date: January 3, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
All patients

All patients will receive the treatment (CABG) and postoperatively three different interventions:

  1. Change in preload and afterload
  2. Change in inspired oxygen
  3. Change in pacemaker modes
Other: Change in preload and afterload
Afterload: Three levels of positive end-expiratory pressure (PEEP) will be examined post-operatively: 0 cm H20, 5 cm H2O, 10 cm H2O Preload: Trendelenburg position for 5 minutes will be investigated
Other: Inspired oxygen
Following fractions of inspired O2 will be investigated: 0.5 and 1.0 for 10 minutes respectively
Other: Pacemaker mode
Following pacemaker settings will be investigated: Atrioventricular pacing 10 bpm over the patients' intrinsic rhythm, atrial pacing 10 bpm over the patients' intrinsic rhythm, ventricular pacing 10 bpm over the patients' intrinsic rhythm

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Elective coronary artery bypass graft patients
  • Normal left ventricular function defined as LVEF over 50 % on TTE preoperatively

Exclusion Criteria:

  • Pre-existing right ventricular malformations
  • Severe right ventricular impairment preoperatively
  • Pre-existing non-sinus rhythm
  • Pre-existing mitral valve stenosis or severe regurgitation
  • Pre-existing pulmonary hypertension
  • Pre-existing tricuspid valve stenosis or severe regurgitation
  • Patients with contraindication to TEE probe placement such as oesophageal stricture or obstruction
  • Patients with contraindication to Swan-Ganz catheter placement
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03301571


Contacts
Contact: Lars Grønlykke, MD 35455624 ext +45 larsgroenlykke@gmail.com
Contact: Hanne Ravn, MD, PhD 35451710 ext +45 hanne.berg.ravn@regionh.dk

Locations
Denmark
Rigshospitalet Recruiting
Copenhagen, Capital Region, Denmark, 2100
Contact: Lars Grønlykke, MD    35455624 ext +45    larsgroenlykke@gmail.com   
Contact: Hanne Ravn, MD, PhD    35451710 ext +45    hanne.berg.ravn@regionh.dk   
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Principal Investigator: Lars Grønlykke, MD Rigshospitalet, Denmark
  More Information

Responsible Party: Lars Grønlykke, Principal investigator, MD, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT03301571     History of Changes
Other Study ID Numbers: 17005565
First Submitted: September 19, 2017
First Posted: October 4, 2017
Last Update Posted: October 4, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Lars Grønlykke, Rigshospitalet, Denmark:
Coronary artery bypass graft
Echocardiography

Additional relevant MeSH terms:
Ventricular Dysfunction
Ventricular Dysfunction, Right
Heart Diseases
Cardiovascular Diseases