YALE UNIVERSITY
Grant: $53,229 - National Institutes of Health - Jul. 20, 2009
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Award Description: The objective of the primary research protocol presented in the PI's parent K-24 renewal application (Complications of Cirrhosis) aimed at comparing the efficacy of a combination of vasoconstrictors (octreotide + midodrine) vs. standard intravenous albumin as an adjuvant to large-volume paracentesis in lengthening the time to recurrence of ascites in patients with cirrhosis. Accrual started in 10/04 and from then until 3/07 (29 months), 38 patients had been screened, of which only 8 had been randomized (sample size required is a minimum of 80 patients). The study's DSMB met in 3/07 and although the study was deemed relevant enough to continue accrual, it suggested hiring a research assistant (RA) specifically dedicated to screening potential study candidates from the oupatient and inpatient services, consenting them, following the procedures required per protocol, including followup of patients and filling out the respective forms. These tasks were previously being performed irregularly and inconsistently by research fellows. Additionally, ther RA regularly contacts Gastroenterology/Hepatology physicians from the greater New Haven area to identify potential candidates for the study. The RA started working in January 2008 with salary costs being covered by the PI's VA Merit Review. In these 13 months, both the screening and accrual of patients has almost tripled, from an initial rate of randomized patients of 0.27/month to a current randomization rate of 0.8/month. This is the result of a marked increase in patients screened (from 47 patients in the initial period of 38 months, to 108 in 13 months). Additionally, patients that are not candidates for this study have been evaluated for participation in a pilot project funded by the Yale Liver Center (NIDDK-funded). The PI's VA Merit Review is at a no-cost extension and funds for the RA's salary will be unavailable as of July 2009 and this will result in loss of employment of this invaluable resource that has kept this important study viable. This is crucial at this point in which the RA has already set up an efficient system and now that a new site has been recruited that will require training of the site's research assistant by the RA.
Project Description: See Award Description
Jobs Summary: None (Total jobs reported: 0)
Project Status: Not Started
This award's data was last updated on Jul. 20, 2009. Help expand these official descriptions using the wiki below.
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