Safety Profile of Iodopovidone as an Agent for Pleurodesis in Malignant Pleural Effusion

• Safety of iodopovidone as an agent for pleurodesis [ Time Frame: Until 30th day after surgical procedure ] [ Designated as safety issue: Yes ]
  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.
  
  

• Quality of life [ Time Frame: Until 1 week before the procedure date and 1 month after it ] [ Designated as safety issue: No ]
  Quality of life questionnaires will be applied until 1 week before the procedure date and on thirty days postoperative as well.
  
  

• Efficacy of iodopovidone as an agent for pleurodesis [ Time Frame: Procedure date and 2nd, 4th, 11st and 30th day after the surgical procedure ] [ Designated as safety issue: No ]
  The efficacy assessment will be based on need of additional pleural surgical procedures.
  
  

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.