Sepsis — Evaluation of Infection in Obstructing Urolithiasis
Citation(s)
Abrahamian FM, Krishnadasan A, Mower WR, Moran GJ, Talan DA Association of pyuria and clinical characteristics with the presence of urinary tract infection among patients with acute nephrolithiasis. Ann Emerg Med. 2013 Nov;62(5):526-533. doi: 10.1016/j.annemergmed.2013.06.006. Epub 2013 Jul 11.
Borofsky MS, Walter D, Shah O, Goldfarb DS, Mues AC, Makarov DV Surgical decompression is associated with decreased mortality in patients with sepsis and ureteral calculi. J Urol. 2013 Mar;189(3):946-51. doi: 10.1016/j.juro.2012.09.088. Epub 2012 Sep 24.
Cheung F, Loeb CA, Croglio MP, Waltzer WC, Weissbart SJ Bacteria on Urine Microscopy Is Not Associated with Systemic Infection in Patients with Obstructing Urolithiasis. J Endourol. 2017 Sep;31(9):942-945. doi: 10.1089/end.2017.0157. Epub 2017 Jun 27.
Fukushima H, Kobayashi M, Kawano K, Morimoto S Performance of Quick Sequential (Sepsis Related) and Sequential (Sepsis Related) Organ Failure Assessment to Predict Mortality in Patients with Acute Pyelonephritis Associated with Upper Urinary Tract Calculi. J Urol. 2018 Jun;199(6):1526-1533. doi: 10.1016/j.juro.2017.12.052. Epub 2017 Dec 29.
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
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Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.
