- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT01169051
A Retrospective Analysis of Statin Use and Outcome After Thoracic Cancer Surgery
Přehled studie
Postavení
Detailní popis
Statins are well established for the use of primary and secondary prevention of cardiovascular disease. Moreover, there is increasing evidence that statins have numerous effects separate from their lipid lowering properties-pleiotropic effects. These pleiotropic effects, including a reduction in the inflammatory response and improved endothelial function, may improve perioperative outcomes via modulation of the surgical stress response. Improved perioperative outcomes have been demonstrated in patients undergoing vascular, cardiac and non-cardiovascular surgery. Specific to the thoracic surgery population, statin use has been reported to reduce the incidence of atrial fibrillation.
Statins, via inhibition of the rate limiting step of the mevalonate pathway, have also sparked interest in their potential anticancer effects as well as in cancer prevention. There is some evidence for anticancer effects of statins in patients with esophageal and lung cancer. Additionally, other agents with known anti-inflammatory effects also point to the potential for improved outcome in cancer patients. In this regard, aspirin use is reported to associate with prolonged survival in breast cancer patients, while perioperative use of anti-inflammatory agents (COX-II inhibitor use and lung cancer; aprotinin use and mesothelioma; aprotinin use and esophageal cancer) is associated with improved postoperative survival. Moreover, the use of regional analgesia is commonly employed in the thoracic surgery population and has been associated with attenuation of metastasis and improvement in recurrence rates for some types of cancers.
In a prospective pilot study of patients undergoing elective thoracic surgery, a collaborative member of our group recently found that patients suffering postoperative complications had poorer endothelial function, as measured by flow mediated dilation. Those patients with poorer endothelial function had greater wound healing complications (6% vs. 0%, p=0.01), longer ICU length of stay (4 vs. 0.9 days, p=0.02), and longer hospital length of stay (14 vs. 6.9 days, p=0.01). Although this pilot study was underpowered to demonstrate a significant correlation between Brachial Artery Reactivity Testing (BART) derived endothelial function and "all" postoperative complications, it provides hypothesis generating data and supports the hypothesis that statins, as modulators of endothelial function, may have a role in improving postoperative outcome.
Typ studie
Zápis (Aktuální)
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
This study is a retrospective chart review of adult thoracic surgery patients who underwent:
- Esophagectomy
- Pulmonary wedge resection
- Pulmonary lobectomy
- Pulmonary pneumonectomy
Data collected will be from January 1, 2007 forward.
Popis
Inclusion Criteria:
This study is a retrospective chart review of adult thoracic surgery patients who underwent:
- Esophagectomy
- Pulmonary wedge resection
- Pulmonary lobectomy
- Pulmonary pneumonectomy
Data collected will be from January 1, 2007 forward
Exclusion Criteria:
None
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
|---|
|
Thoracic sugery statins
|
|
Thoracic surgery non-statins
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
|---|
|
Effect of perioperative statin use on in-hospital morbidity after thoracic cancer surgery
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Effect of perioperative statin use on the development of Major Adverse Pulmonary Events (MAPE)
Časové okno: 30 days after initial surgery
|
Includes acute lung injury, acute respiratory distress syndrome, pulmonary embolus, respiratory failure requiring mechanical ventilation and pneumonia
|
30 days after initial surgery
|
|
Effect of perioperative statin use and the development of Major Adverse Cardiac Events (MACE)
Časové okno: 30 days after initial surgery
|
Includes atrial fibrillation, other arrhythmia, myocardial infarction and congestive heart failure.
|
30 days after initial surgery
|
|
Effect of perioperative statin on mortality associated with cancer recurrence following thoracic cancer surgery.
|
Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Justin Sandall, D.O., Vanderbilt University
- Ředitel studie: Mias Pretorius, M.D., Vanderbilt University
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhadovaný)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 100698
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