Pleural Effusion Clinical Trial
Official title:
The Effect of Perioperative Non-Steroidal Anti-Inflammatory Drug Naproxen on Pleural Effusion Formation After Lung Resection
Verified date | September 2016 |
Source | McMaster University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Following a lung resection procedure, patients have their pleural space drained of fluid that accumulates due to the severing of proximal vessels like lymph nodes. The volume of fluid pumped depends on the severity of the inflammation. The investigators are conduction this study to attempt to use painkillers with intrinsic anti-inflammatory action to try and reduce the degree of inflammation in patients' pleural cavity, thus ensuring patients are discharged faster, with a greater comfort level, and a hopefully lower rate of admission.
Status | Terminated |
Enrollment | 7 |
Est. completion date | January 2018 |
Est. primary completion date | January 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility |
Inclusion Criteria: - Participants must be 18 years of age or older - Participants must be undergoing a major lung resection due to primary or secondary malignancy - Must have an aptitude for following directions and commitment to the study Exclusion Criteria: - Patients who are unable to read and communicate in English - Patients undergoing a pneumonectomy or Open lung resection - Previous treatments on the same anatomical side including chemotherapy, radiation therapy, and radio-frequency ablation - Patients who have undergone decortication for empyema or malignancy. - Patients who have a chest tube in-situ for persistent air leak - Patients with clinical or laboratory indicators of renal failure, defined as serum creatinine level of 170µmol/l - Patients with active or previous history of peptic ulcer disease - Patients with a known intolerance to Proton Pump Inhibitors (PPIs) - Known allergy to study drugs - Use of NSAIDs 4 weeks prior to randomization or on-going use of NSAIDs. - The use of any medications known to reduce inflammation, including but not limited to: steroids (both oral and intravenously), methotrexate, COX-II inhibitors, other NSAIDs - Chest tube for persistent air leak. - Patients who are pregnant or lactating - Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements. - Inability or unwillingness of individual or legal guardian/representative to give written informed consent |
Country | Name | City | State |
---|---|---|---|
Canada | St. Joseph's Healthcare Hamilton | Hamilton | Ontario |
Lead Sponsor | Collaborator |
---|---|
McMaster University | McMaster Surgical Associates |
Canada,
Ackerman N, Tomolonis A, Miram L, Kheifets J, Martinez S, Carter A. Three day pleural inflammation: a new model to detect drug effects on macrophage accumulation. J Pharmacol Exp Ther. 1980 Dec;215(3):588-95. — View Citation
Cerfolio RJ, Bryant AS. Results of a prospective algorithm to remove chest tubes after pulmonary resection with high output. J Thorac Cardiovasc Surg. 2008 Feb;135(2):269-73. doi: 10.1016/j.jtcvs.2007.08.066. — View Citation
Kroegel C, Antony VB. Immunobiology of pleural inflammation: potential implications for pathogenesis, diagnosis and therapy. Eur Respir J. 1997 Oct;10(10):2411-8. Review. — View Citation
Scheiman JM, Hindley CE. Strategies to optimize treatment with NSAIDs in patients at risk for gastrointestinal and cardiovascular adverse events. Clin Ther. 2010 Apr;32(4):667-77. doi: 10.1016/j.clinthera.2010.04.009. Review. — View Citation
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Trelle S, Reichenbach S, Wandel S, Hildebrand P, Tschannen B, Villiger PM, Egger M, Jüni P. Cardiovascular safety of non-steroidal anti-inflammatory drugs: network meta-analysis. BMJ. 2011 Jan 11;342:c7086. doi: 10.1136/bmj.c7086. Review. — View Citation
Watanabe A, Watanabe T, Ohsawa H, Mawatari T, Ichimiya Y, Takahashi N, Sato H, Abe T. Avoiding chest tube placement after video-assisted thoracoscopic wedge resection of the lung. Eur J Cardiothorac Surg. 2004 May;25(5):872-6. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in volume of pleural effusion collected | The investigators are looking to measure the volume of pleural effusion collected from in-situ chest tubes in patients following a lung resection, measured in mL | 4 weeks | |
Secondary | Hospital length of stay; compared between intervention and control arms | The length of stay will be measured from the admitting day to the day of discharge to home. | 4 weeks | |
Secondary | Gastrointestinal complications | Recorded as a binary event, adverse events related to the gastrointestinal tract may occur in participants undergoing treatment. The extent of this occurrence will determine whether or not further intervention by the Data and Safety Monitoring Committee is necessary. | 4 weeks | |
Secondary | General re-admission rates | Participants recently discharged following a lung resection have a chance to be re-admitted for a post-operative complication. This will be measured as a binary event and the total associated length of stay associated with the episode. | 4 weeks | |
Secondary | Total number of days chest tubes remain in-situ | This outcome is related to the volume of pleural effusion produced and will measure the time chest tubes remain in place following surgery, measured in days. | 4 weeks |
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