Safety Profile of Iodopovidone as an Agent for Pleurodesis in Malignant Pleural Effusion
Safety Profile of Iodopovidone as an Agent for Pleurodesis in Malignant Pleural Effusion
Iodopovidone is safe when using as a pleurodesis sclerosing agent for malignant pleural
 effusion, with minimal adverse events, especially reducing dose.
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 was 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 was evaluated by the same authority pursuant and the study group
 included only those who agree to participate and signed an approved. There included patients
 with malignant pleural effusion diagnosis. Main exclusion criteria were iodine allergia,
 renal failure, thyroid disease, refusal to sign the informed consent and patients unable to
 respond the quality of life questionnaire. After inclusion, patients were randomized and
 assigned to two groups according to the iodopovidone concentration solution: 1% or 2%. All
 procedures were performed by infusion of the solution through a chest tube previously
 placed.The data analysis involved clinical measures and complementary exams trying to
 evaluate all organ systems and sorting through possible adverse effects, classifying those as
 CTCAEV. Clinical measures involved 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.
 Such measures were performed in the preoperative, immediate postoperative, second, fourth,
 eleventh and thirty days postoperative. Quality of life questionnaires was applied before and
 on thirty days postoperative as well. After that, randomized groups were compared.
Inclusion Criteria:

 -  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

 Exclusion Criteria:

 -  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