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Trial record 33 of 537 for:    NITRATE ION

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01125124
Recruitment Status : Unknown
Verified April 2010 by University of Sao Paulo General Hospital.
Recruitment status was:  Recruiting
First Posted : May 18, 2010
Last Update Posted : May 18, 2010
Sponsor:
Information provided by:
University of Sao Paulo General Hospital

Tracking Information
First Submitted Date  ICMJE April 26, 2010
First Posted Date  ICMJE May 18, 2010
Last Update Posted Date May 18, 2010
Study Start Date  ICMJE August 2009
Estimated Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 14, 2010)
  • Chest pain on the first five days after pleurodesis [ Time Frame: Along the first five days after treatment ]
    Chest pain will be evaluated via Visual Analog Scale.
  • Chest pain after 10 days of pleurodesis [ Time Frame: On the 10th day after the procedure. ]
    Chest pain will be assessed using the Visual Analog Scale
  • Chest pain after 30 days of pleurodesis [ Time Frame: Within 30 days of the procedure ]
    Chest pain will be evaluated by Visual Analog Scale
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 14, 2010)
  • Effectiveness of the pleurodesis [ Time Frame: After 30 days of the procedure ]
    On hospital discharge, five days after the procedure, patients are submitted to chest computerized tomography (CT). After 30 days of the procedure, patients are submitted to another chest CT and the volume of pleural effusion is calculated and compared to that of the hospital discharge date (calculated by the 5th day CT).
  • Dyspnea [ Time Frame: Before the procedure, during the first five days after the procedure, ten days after the procedure and on the 30th day post-procedure. ]
    Dyspnea will be evaluated through the British MRC dyspnea scale.
  • Adverse effects [ Time Frame: Within the first 5 days after the procedure, on the 10th day after the procedure and on the 30th day after the procedure ]
    The safety of the treatment will be assessed both by monitoring of complete blood counts, renal function, liver function and inflammation markers, as well as monitoring of body temperature, arterial blood pressure and heart rate. The occurrence of adverse side effects will be assessed using the United States National Cancer Institute Common Terminology Criteria for Adverse Events v.3.0.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Effectiveness Study for Pleurodesis With Silver Nitrate in Malignant Pleural Effusion
Official Title  ICMJE Evaluation of Chest Pain, Effectiveness and Safety of Pleurodesis With Pleural Catheters and Silver Nitrate for Malignant Pleural Effusion.
Brief 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.
Detailed Description

Malignant pleural effusion is a frequent complication in advanced neoplasia. Pleurodesis is the procedure of choice for symptomatic control, with talc as the sclerosing agent of choice. However, the occurrence of severe adverse effects associated with its use has led to the search for other agents.

Silver nitrate poses an option, presenting excellent results in animal models and having successful usage in pleurodesis in the past. Although important, the current literature on the effective use of silver nitrate for pleurodesis is still too scarce, and a deeper knowledge on the occurrence of adverse side effects, especially pain, is still necessary to allow the substance to be considered as an effective alternative to talc, as well as for the definition of an adequate dosage.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Malignant Pleural Effusion
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Active Comparator: Silver Nitrate 1
    Patients submitted to pleurodesis via pleural catheter using 30ml of 0.5% silver nitrate solution.
    Intervention: Drug: Silver Nitrate
  • Experimental: Silver Nitrate 2
    Patients submitted to instilation of 30ml 0.3% silver nitrate solution via pleural catheter.
    Intervention: Drug: Silver Nitrate
  • Experimental: Silver Nitrate 3
    Patients submitted to instilation of 60ml 0.3% silver nitrate solution via pleural catheter.
    Intervention: Drug: Silver Nitrate
Publications * Paschoalini Mda S, Vargas FS, Marchi E, Pereira JR, Jatene FB, Antonangelo L, Light RW. Prospective randomized trial of silver nitrate vs talc slurry in pleurodesis for symptomatic malignant pleural effusions. Chest. 2005 Aug;128(2):684-9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 14, 2010)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2010
Estimated Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Malignant pleural effusion confirmed by cytologic analysis of the fluid and/or pleural biopsy.
  • Recurrent and symptomatic malignant pleural effusion.
  • Full pulmonary expansion (>90%) post thoracocentesis, confirmed via chest x-ray.
  • Karnofsky Performance Status >30
  • Agreement to participate of the study by signing of the Informed Consent Term.

Exclusion Criteria:

  • Coagulopathies (prothrombin activity <50%) and/or thrombocytopenia (<80000 count).
  • Active pleural or systemic infection.
  • Massive skin neoplastic infiltration.
  • Inability of understanding the pain scale.
  • Previous pleural procedures (except for thoracocentesis and/or pleural biopsy).
  • Refusal to participate of the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01125124
Other Study ID Numbers  ICMJE 1041/09
1041/09 ( Other Identifier: University of Sao Paulo General Hospital Research Committee )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr Ricardo Mingarini Terra, INCOR-HCFMUSP
Study Sponsor  ICMJE University of Sao Paulo General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ricardo M Terra, MD University of Sao Paulo General Hospital
PRS Account University of Sao Paulo General Hospital
Verification Date April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP