Right Ventricular Dysfunction in Cardiac Surgery Patients

• Sponsor: Medical Centre Leeuwarden (Other)
• Overall Status: Completed
• CT.gov ID: NCT03183414
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Actual Duration (Months): 9.8
• Patients Per Site Per Month: 1.5

Study Details

Study Description

Brief Summary

To establish the correlation between echocardiographic parameters of the RV, measured with TEE and the right ventricular ejection fraction (thermodilution). To identify a time in the perioperative process when RV dysfunction occurs.

Condition or Disease	Intervention/Treatment	Phase
Right Ventricular Dysfunction	Other: echocardiographic measurements

Detailed Description

Measurements with echocardiography were done during cardiac surgery to observe the right ventricular dysfunction in the perioperative process

Study Design

• Study Type: Observational
• Actual Enrollment: 15 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Right Ventricular Dysfunction in Cardiac Surgery
• Actual Study Start Date: Sep 6, 2017
• Actual Primary Completion Date: Jun 20, 2018
• Actual Study Completion Date: Jun 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
cardiac surgery patients cardiac surgery patients with a significant peroperative aortic valve stenosis (gradient>40mmHg and/or aortic valve area <1cm2). During cardiac surgery measurements of right ventricular dysfunction were taken by echocardiography	Other: echocardiographic measurements; echocardiographic parameters of the RV, measured with TEE and the right ventricular ejection fraction (thermodilution)

Outcome Measures

Primary Outcome Measures

1. The correlation between echocardiographic parameters of the RV, measured with TEE and the RVEF measured with the pulmonary artery catheter [during cardiac surgery]

   The correlation between echocardiographic parameters of the RV, measured with TEE and the RVEF measured with the pulmonary artery catheter.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• cardiac surgery patients

• elective, isolated aortic valve replacement or coronary artery bypass grafting in combination with aortic valve replacement

Exclusion Criteria:

• age < 18

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical Centre Leeuwarden	Leeuwarden		Netherlands	8934AD

Sponsors and Collaborators

• Medical Centre Leeuwarden

Investigators

• Principal Investigator: Christiaan Boerma, MD, MCL

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Matty Koopmans, MSc, Medical Centre Leeuwarden
• ClinicalTrials.gov Identifier: NCT03183414
• Other Study ID Numbers: nWMO 220
• First Posted: Jun 12, 2017
• Last Update Posted: Nov 26, 2019
• Last Verified: Nov 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• 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 Matty Koopmans, MSc, Medical Centre Leeuwarden: cardiac surgery; transoesophageal echocardiography
• Additional relevant MeSH terms: Ventricular Dysfunction; Ventricular Dysfunction, Right

Study Results

No Results Posted as of Nov 26, 2019