? ? The Data Coordinating Center (DCC) for the Frequent Hemodialysis Network (FHN) will continue to coordinate the scientific and operational aspects of the two FHN clinical trials: one comparing short in-center 6x/week dialysis with conventional 3x/week dialysis and one comparing long home nocturnal 6x/week dialysis with home conventional 3x/week dialysis. During the on-going recruitment and follow-up of each FHN trial, the DCC will monitor patient recruitment and compliance as a whole and by clinical center. The database management system previously developed is used to assure accurate and complete collection of trial data. An inquiry system is used to resolve data discrepancies. The DCC will continue to make changes as necessary in the forms, database, manuals of operation, FHN web site, and reports. Many of the interactions with the clinical investigators are done through the work of subcommittees. The DCC will provide yearly centralized training of clinical center staff on the entry of trial patients, the completion of trial forms, and the use of the data management system. The DCC will promote adherence to the trial protocols. Site visit calls or visits to the clinical centers are made as necessary. Trial progress is given in reports to the clinical centers, Steering Committee, and Data Safety and Monitoring Board. Statistical analyses are performed during the course of each trial with final outcome analyses completed and reported at the end of each trial. The DCC handles the planning of meetings and conference calls, and administrative tasks. The DCC will develop new statistical methodology as needed to properly analyze the data being collected. Biological specimens and trial data (at end) are transferred to NIDDK repositories. Since the FHN is a multi-centered effort on two trials, the DCC will provide leadership to coordinate each trial's conduct to optimize resources and gain efficiencies. The DCC will work to foster a spirit of cooperation, which is important in this network. Results from the FHN trials will lead to a better understanding of more frequent hemodialysis beyond the conventional 3x/week and its impact on many outcomes affecting the health and well-being of hemodialysis patients. ? ? ?

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project--Cooperative Agreements (U01)
Project #
2U01DK066597-05
Application #
7522919
Study Section
Special Emphasis Panel (ZDK1-GRB-N (J1))
Program Officer
Eggers, Paul Wayne
Project Start
2003-09-30
Project End
2012-01-31
Budget Start
2008-08-15
Budget End
2009-01-31
Support Year
5
Fiscal Year
2008
Total Cost
$1,167,694
Indirect Cost
Name
Cleveland Clinic Lerner
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
135781701
City
Cleveland
State
OH
Country
United States
Zip Code
44195
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Lo, Joan C; Beck, Gerald J; Kaysen, George A et al. (2017) Thyroid function in end stage renal disease and effects of frequent hemodialysis. Hemodial Int 21:534-541
Alpers, Charles E; Imrey, Peter B; Hudkins, Kelly L et al. (2017) Histopathology of Veins Obtained at Hemodialysis Arteriovenous Fistula Creation Surgery. J Am Soc Nephrol 28:3076-3088
Robbin, Michelle L; Greene, Tom; Cheung, Alfred K et al. (2016) Arteriovenous Fistula Development in the First 6 Weeks after Creation. Radiology 279:620-9
Allon, Michael; Greene, Tom; Dember, Laura M et al. (2016) Association between Preoperative Vascular Function and Postoperative Arteriovenous Fistula Development. J Am Soc Nephrol 27:3788-3795
Dember, Laura M; Imrey, Peter B; Duess, Mai-Ann et al. (2016) Vascular Function at Baseline in the Hemodialysis Fistula Maturation Study. J Am Heart Assoc 5:
Farber, Alik; Imrey, Peter B; Huber, Thomas S et al. (2016) Multiple preoperative and intraoperative factors predict early fistula thrombosis in the Hemodialysis Fistula Maturation Study. J Vasc Surg 63:163-70.e6
Ferrario, Manuela; Raimann, Jochen G; Larive, Brett et al. (2015) Non-Linear Heart Rate Variability Indices in the Frequent Hemodialysis Network Trials of Chronic Hemodialysis Patients. Blood Purif 40:99-108
Dember, Laura M; Imrey, Peter B; Beck, Gerald J et al. (2014) Objectives and design of the hemodialysis fistula maturation study. Am J Kidney Dis 63:104-12

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