Clinical Trials Logo
  1. Home
  2. Heart Disease
  3. NCT02045641

Pleural and Pericardial Effusion Following Open Heart Surgery — IMAGING  

Heart Disease Clinical Trial

Official title:
The Clinical Impact of an Aggressive Approach Towards Pleural and Pericardial Effusions Following Open Heart Surgery: a Step Towards Standard Guidelines

Clinical Trial Summary

One of the most common postoperative complications after open cardiac surgery is fluid accumulation between the pleural membranes or in the pericardial sac. This study investigates the consequence of such fluid accumulations on physical performance, recovery-time, cardiac and respiratory complications, and quality of life. Half of the participants will be followed closely and offered fluid drainage at a low threshold, and half of the participants will follow the current postoperative regimen.

Clinical Trial Description

Introduction:

Knowledge concerning the impact of pleural and pericardial effusions on physical performance, recovery-time, cardiac and respiratory complications, and quality of life after open cardiac surgery is scarce. A more aggressive approach towards effusions has been suggested, but further studies are needed.

Objectives:

1. to determine the size of pleural and pericardial effusion that results in at least 30% reduction of physical performance in the 6-minute walk test.

2. to compare the improvement in physical performance between the intervention group and the control group, measured from baseline to day 30 after surgery.

Materials and methods:

A randomised controlled intervention trial. Patients admitted for open cardiac surgery (aortic valve surgery, coronary artery bypass graft surgery and combinations) will be randomised into either an intervention group or a control group. The intervention group will be followed with physical tests and ultrasonic examination the month following surgery. Pleural or pericardial effusion of a predefined size will be drained. The control group will follow the current postoperative regimen. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02045641
Study type Interventional
Source Aarhus University Hospital Skejby
Contact
Status Completed
Phase N/A
Start date September 2013
Completion date November 2015
View Details
See also
  Status Clinical Trial Phase
Completed NCT03481322 - Low Sodium Cooking Study N/A
Completed NCT00001638 - Magnetic Resonance Imaging of the Blood Vessels of the Heart
Completed NCT02376244 - The Health Impact of High Intensity Exercise Training With Intervals During Cardiac Rehabilitation N/A
Completed NCT02523144 - Dexmedetomidine in Children Having Transthoracic Echocardiography Phase 4
Completed NCT02277379 - Prediction of Bleeding and Transfusion Outcomes and Assessment of Perioperative Platelet Reactivity in Cardiac Surgery N/A
Completed NCT01871090 - Remote Device Interrogation In The Emergency Department N/A
Active, not recruiting NCT01400490 - Eicosapentaenoic Acid (EPA)and Docosahexaenoic Acid Study N/A
Completed NCT01192360 - Dynamic Contrast Enhanced Magnetic Resonance Perfusion Imaging in Congenital Heart Disease and Lung Disease Phase 3
Terminated NCT00935766 - Effect of Fish Oil (Omega-3 Fatty Acids) on Arteries Phase 3
Completed NCT00745446 - The Effect of a Retrofit Particle Trap on the Vascular Effects of Diesel Exhaust Inhalation N/A
Completed NCT00140816 - Dairy Products and Metabolic Effects (Norwegian Part) N/A
Completed NCT00178620 - Pre-hospital Administration of Thrombolytic Therapy With Urgent Culprit Artery Revascularization Phase 4
Completed NCT00013949 - Cardiovascular Vulnerability to Particulate Exposure N/A
Completed NCT01952171 - The Genetic Basis of Congenital Heart Disease in Africa
Recruiting NCT02933892 - Benefit of Transradial Approach in Chronic Kidney Disease Population Undergoing Cardiac Catheterization Phase 4
Withdrawn NCT02838355 - Employing End Tidal Capnography in Continuous Flow Ventricular Assist Device Patients N/A
Completed NCT02923518 - Cardiac Screening of Middle Aged and Older Women and Men (Master Athletes)
Terminated NCT02282163 - Evaluation of Safety and Efficacy of Lumason in Pediatric Echocardiography Phase 3
Active, not recruiting NCT02260466 - Prevalence and Post-surgical Outcomes of CARdiac Wild-type TransthyrEtin amyloidoSIs in Elderly Patients With Aortic steNosis Referred for Valvular Replacement. N/A
Completed NCT03820752 - Vaccination Coverage and Level of Protection in Patients at Risk