Thoracoscopy Versus Fibrinolysis in Children With Empyema

NCT00323531 | Completed Phase 2

• 1 other identifier: 06 01-019
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The null hypothesis is that patients receiving either thoracoscopy or fibrinolysis for empyema recover in the same amount of time. Therefore, we will test this by randomizing the next 40 patients who consent to the study to one treatment or the other.

Conditions

Empyema

Keywords

thoracoscopy; fibrinolysis; empyema; children

Outcome Measures

Primary Outcomes (1)

• Length of hospitalization after intervention

  1 month

Secondary Outcomes (1)

• Days where a maximum temperature was equal to or above 38 degrees C, days of tube drainage, doses of analgesia and days of oxygen requirement, hospital days after intervention, hospital charges after intervention and procedure charges

  1 month

Study Arms (2)

1

ACTIVE COMPARATOR

Video assisted thoracoscopic decortication

Procedure: VATS decortication

2

EXPERIMENTAL

Fibrinolysis through the chest tube

Procedure: Chest tube with tPA infusion for 3 days

Interventions

Chest tube with tPA infusion for 3 days PROCEDURE

fibrinolysis through the chest tube

Also known as: Fibrinolysis, tPA

2

VATS decortication PROCEDURE

thoracoscopic decortication

Also known as: VATS, pleural debridement

1

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients less than 18 years of age requiring an intervention for empyema by one of the following:
• Septation or loculation seen on ultrasound or computed tomography
• Many white blood cells, bacteria present, or thick viscid purulence identified on pleural tap

You may not qualify if:

• Immunodeficiency process
• Secondary diagnosis or condition that will keep them in the hospital beyond the empyema
• Existing contraindications to VATS or chest tube.

Sponsors & Collaborators

• Children's Mercy Hospital Kansas City: lead

Study Sites (1)

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

MeSH Terms

Conditions

Empyema

Interventions

Chest Tubes; Fibrinolysis; Thoracic Surgery, Video-Assisted

Condition Hierarchy (Ancestors)

Suppuration; Infections; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Equipment; Equipment and Supplies; Blood Coagulation; Hemostasis; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Thoracoscopy; Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Video-Assisted Surgery; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Thoracic Surgical Procedures

Study Officials

• Shawn D St. Peter, MD

  Children's Mercy Hospital Kansas City

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 8, 2006
• First Posted: May 9, 2006
• Study Start: March 1, 2006
• Primary Completion: October 1, 2007
• Study Completion: October 1, 2007
• Last Updated: May 9, 2008

Record last verified: 2008-05

Locations

US (1)