Safety Profile of Iodopovidone as an Agent for Pleurodesis in Malignant Pleural Effusion
Condition: Pleural Effusion, Malignant
MeSH terms: Pleural Effusion, Malignant; Pleural Effusion
Study type: Interventional
Phase: Phase 4

Summary: 
      Iodopovidone is safe when using as a pleurodesis sclerosing agent for malignant pleural
      effusion, with minimal adverse events, especially reducing dose.
    

Detailed description: 
      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.
    

Intervention name(s): pleurodesis
Intervention type(s): Procedure
Intervention description(s): Comparison of two dosages of iodopovidone as an agent for pleurodesis in malignant pleural effusion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment