Safety Profile of Iodopovidone as an Agent for Pleurodesis in Malignant Pleural Effusion
Background: Chemical pleurodesis is the treatment of choice in most cases of malignant
pleural effusion. The literature mentions a variety of chemicals which may be used for this
purpose, each with its own advantages and disadvantages. The iodopovidone has been recently
studied due to the existence of some side effects of other agents. Nevertheless, there are
still some questions in the literature regarding its safety and possible adverse effects.
Because of these questions, we propose the development of a study to ensure the safety and
efficacy of iodopovidone as a pleurodesis sclerosing agent.
Objective: The main purpose of this study is to evaluate the safety of pleurodesis for
malignant pleural effusion using iodopovidone as a sclerosing agent in different doses. The
secondary objectives are to determine clinical efficacy and quality of life of the patients
after realization of the proposed procedure.
Methods: There will be a randomized clinical trial, covering patients diagnosed with
malignant pleural effusion at Hospital Aristides Maltez - Bahia League Against Cancer. The
research will be revised and approved by the Ethics in Research of the Heart Institute,
Hospital das Clínicas - FMUSP and of the Hospital Aristides Maltez - Bahia League Against
Cancer. The free and informed consent will be evaluated by the same authority pursuant and
the study group will include only those who agree to participate and signed an approved.
There will be included patients with malignant pleural effusion diagnosis. Main exclusion
criteira will be iodine allergie, renal failure, thyroid disease, refusal to sign the
informed consent and patients unable to respond the quality of life questionnaire. After
inclusion, patients will be randomized and assigned to two groups according to the
iodopovidone concentration solution: 1% or 2%. All procedures will be performed by infusion
of the solution through a chest tube previously placed.The data analysis will involve
clinical measures and complementary exams trying to evaluate all organ systems and sorting
through possible adverse effects, classifying those as CTCAEV. Clinical measures will
involve MRC dyspnea schedule, analogic visual pain schedule, visual acuity test, measurement
of pulse oximetry, heart rate, blood pressure and temperature. Complementary exams will be
chest x-ray, eletrocardiogram and laboratory tests. Such measures shall be performed in the
preoperative, immediate postoperative, second, fourth, eleventh and thirty days
postoperative. Quality of life questionnaires will be applied before and on thirty days
postoperative as well. After that, randomized groups will be compared.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Safety of iodopovidone as an agent for pleurodesis
The safety will be 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 will be chest x-ray, eletrocardiogram and laboratory tests.
Until 30th day after surgical procedure
Ricardo M Terra, MD, PhD
InCor Heart Institute
Brazil: National Committee of Ethics in Research