Pleural and Pericardial Effusion Following Open Heart Surgery

NCT02045641 | Completed DMC

• 1 other identifier: 1-10-72-246-13
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Disease; Pleural Effusion; Pericardial Effusion

Keywords

cardiac surgery; postoperative treatment; pleural effusion; physical performance

Outcome Measures

Primary Outcomes (1)

• change in walking distance before and after intervention

  The primary outcome measure is the change in walking distance before and after pleuracentesis, subsequently the size of pleural effusion (both cm measured on ultrasound and drained volume) that results in a reduction of distance in the 6 minute walk test of at least 30%.

  day 4, day 15, day 30

Secondary Outcomes (1)

• change in walking distance from baseline to day 30 after surgery

  day 0 and day 30

Other Outcomes (1)

• needle pleuracentesis versus pigtail catheter

  day 0, day 4, day 15 and day 30

Study Arms (2)

current postoperative regimen

NO INTERVENTION

The group will follow the current postoperative regimen at the surgical ward; screening for pleural effusions with x-ray and further diagnostic procedures in case of symptoms. Treatment will be entirely in the hands of the clinical personnel.

pleuracentesis

EXPERIMENTAL

The group will follow the current postoperative regimen. In addition they will be followed with ultrasound examination, clinical examination, spirometry examination and 6 minute walk test. In case of either a) pleural effusion \> 400ml OR b) pleural effusion\< 400ml with symptoms in rest or during the walk test, the effusion will be drained and examinations will be repeated. In case of pericardial effusion of predefined size and location, either the surgeon on call or a cardiologist will be consulted.

Procedure: pleuracentesis

Interventions

pleuracentesis PROCEDURE

Direct needle drainage of pleural effusions with dynamic ultrasound technique

pleuracentesis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 years.
• Admitted for elective aortic valve surgery, coronary artery bypass graft surgery or combinations.
• Be able to understand the written and oral patient information and to give informed consent.

You may not qualify if:

• Surgical combinations involving the mitral valve since they are already examined with full echocardiography prior to discharge, which may influence protocol driven decisions.
• Simultaneous participation in any other clinical intervention trial

Sponsors & Collaborators

• Aarhus University Hospital Skejby: lead

Study Sites (1)

Aarhus University Hospital

Aarhus N, 8200, Denmark

Location

Related Publications (1)

• Hansen LS, Hjortdal VE, Jakobsen CJ, Heiberg J, Maagaard M, Sloth E. Early, dedicated follow-up and treatment of pleural effusions enhance the recovery rate after open cardiac surgery: results from a randomized, clinical trial. Eur J Cardiothorac Surg. 2017 Jan;51(1):58-66. doi: 10.1093/ejcts/ezw233. Epub 2016 Jul 11.

  PMID: 27401709 DERIVED

MeSH Terms

Conditions

Heart Diseases; Pleural Effusion; Pericardial Effusion

Interventions

Thoracentesis

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Pleural Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Paracentesis; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Vibeke E. Hjortdal, MD PHD DMSc

  Aarhus University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PHD fellow

Study Record Dates

• First Submitted: January 21, 2014
• First Posted: January 27, 2014
• Study Start: September 1, 2013
• Primary Completion: October 1, 2015
• Study Completion: November 1, 2015
• Last Updated: November 17, 2015

Record last verified: 2015-11

Locations

DK (1)