Safety Profile of Iodopovidone as an Agent for Pleurodesis in Malignant Pleural Effusion
1 other identifier
interventional
60
1 country
1
Brief Summary
Iodopovidone is safe when using as a pleurodesis sclerosing agent for malignant pleural effusion, with minimal adverse events, especially reducing dose.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jan 2010
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
August 7, 2012
CompletedFirst Posted
Study publicly available on registry
August 22, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedMay 13, 2014
May 1, 2014
3.5 years
August 7, 2012
May 12, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Safety of iodopovidone as an agent for pleurodesis
The safety was assessed by mean clinical measures as MRC dyspnea schedule, analogic visual pain schedule, visual acuity test, measurement of pulse oximetry, heart rate, blood pressure and temperature. Complementary exams were chest x-ray, electrocardiogram and laboratory tests.
Until 30th day after surgical procedure
Secondary Outcomes (1)
Quality of life
Until 1 week before the procedure date and 1 month after it
Other Outcomes (1)
Efficacy of iodopovidone as an agent for pleurodesis
Procedure date and 2nd, 4th, 11st and 30th day after the surgical procedure
Study Arms (2)
Iodopovidone 1%
EXPERIMENTALThe patients enrolled in this arm were submitted to pleurodesis with iodopovidone 1% administration into pleural cavity.
Iodopovidone 2%
EXPERIMENTALThe patients enrolled in this arm were submitted to pleurodesis with iodopovidone 2% administration into pleural cavity.
Interventions
Comparison of two dosages of iodopovidone as an agent for pleurodesis in malignant pleural effusion
Eligibility Criteria
You may qualify if:
- malignant pleural effusion
- Recurrent pleural effusion
- Complete lung expansion (\> 80%) after puncture emptying confirmed by chest radiography.
- Karnofsky index \> 40.
- Agreed to participate in the study and sign an Informed Consent
You may not qualify if:
- Thrombocytopenia or coagulation disorders
- Patients with impaired renal function
- Pleural or active systemic infection
- Massive neoplastic infiltration of the skin
- Inability to understand the quality of life questionnaire
- Previous pleural procedures
- Allergy to iodine
- Thyroid disorders
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Grupo de Pesquisa em Pleura e Oncologia Toracicalead
- Instituto do Coracaocollaborator
- Instituto do Cancer do Estado de São Paulocollaborator
Study Sites (1)
Hospital Aristides Maltez
Salvador, Estado de Bahia, 40285-001, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Ricardo M Terra, MD, PhD
InCor Heart Institute
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 7, 2012
First Posted
August 22, 2012
Study Start
January 1, 2010
Primary Completion
July 1, 2013
Study Completion
July 1, 2013
Last Updated
May 13, 2014
Record last verified: 2014-05