ISRCTN10499680
Active, not recruiting
未知
A feasibility study evaluating the efficacy of indwelling pleural catheters plus sclerosant in persistent symptomatic pleural effusions secondary to heart failure
orth Bristol NHS Trust0 sites18 target enrollmentAugust 12, 2021
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Recurrent pleural effusion secondary to heart failure
- Sponsor
- orth Bristol NHS Trust
- Enrollment
- 18
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. The presence of a recurrent pleural effusion secondary to heart failure that has not responded to medical therapy
- •2\. Sufficient pleural fluid for IPC insertion
- •3\. Symptomatic breathlessness warranting pleural intervention
- •4\. Pleural infection excluded to satisfaction of treating physician
- •5\. Expected survival \>12 weeks
- •6\. Written informed consent to trial participation
Exclusion Criteria
- •1\. Age \<18 years
- •2\. Known pleural malignancy
- •3\. Pregnancy, lactation or intention to become pregnant
- •4\. Absolute contraindication to IPC insertion or therapeutic aspiration of pleural fluid
- •5\. Previous attempts at ipsilateral pleurodesis
- •6\. Evidence of extensive lung entrapment on chest x\-ray or CT, or significant fluid loculation on ultrasound scan, to a level which would normally be a contraindication to attempted talc pleurodesis or IPC insertion.
- •7\. Inability to give informed consent
- •8\. Patient has no access to a telephone
Outcomes
Primary Outcomes
Not specified
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