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Safety and Effectiveness Study for Pleurodesis With Silver Nitrate in Malignant Pleural Effusion

NCT01125124 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2010-05-18

No results posted yet for this study

Summary

The primary purpose of this study is to determinate the degree of chest pain on patients with malignant pleural effusion submitted to pleurodesis with silver nitrate in three different dosages and concentrations ( 30ml 0.5% ; 30ml 0.3% ; 60ml 0.3%). Our secondary purpose is to evaluate the efficacy and occurence of adverse effects in the usage of silver nitrate for pleurodesis in the aforementioned dosages/concentrations.

Conditions

  • Malignant Pleural Effusion

Interventions

DRUG

Silver Nitrate

Instilation of silver nitrate solution through the pleural catheter. The catheter remains closed for 1h after the procedure and is then reopened. There will be 3 different dosages, corresponding to the 3 different arms.

Sponsors & Collaborators

  • University of Sao Paulo General Hospital

    lead OTHER

Principal Investigators

  • Ricardo M Terra, MD · University of Sao Paulo General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01125124 on ClinicalTrials.gov