Impact of Adherence to Anemia Management Policy on Repeat Hospitalization in End Stage Renal Disease (ESRD)
NCT ID: NCT01017627
Last Updated: 2010-04-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
1500 participants
INTERVENTIONAL
2009-11-30
2010-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Association Between the Distributions MCH and RBC, and Mortality in Hemodialysis Patients
NCT04227158
Ferumoxytol Versus Oral Iron in the Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease Patients
NCT00255437
Ferumoxytol Versus Oral Iron in the Treatment of Anemia in Hemodialysis Patients
NCT00233597
Evaluation of Monthly Darbepoetin Alfa Dosing for Correction of Anemia in Non-dialysis Chronic Kidney Disease
NCT00925587
Ferumoxytol Versus Oral Iron in the Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease Patients
NCT00255424
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Patient outcomes will be followed for up to 30 days from the time of discharge from hospital.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Early anemia management
Upon return to the dialysis unit following hospitalization, patients will be immediately identified and have immediate implementation of the unit anemia protocol rather than waiting for the next regularly scheduled unit labs and regular follow-up. Thus, labs will be obtained within the first 3-7 days following hospitalization and appropriate titration of Epo and iron medications within the 7 days after discharge from hospital and under the direction of the pre-specified algorithm used in the patient's facility; all drug dosing will comply with package insert instructions
Early anemia diagnosis and treatment
Patients returning to the unit are immediately assessed and treated for anemia
case control
Each case will be "data-matched" to an intra-facility (primary control), and then an inter-facility (validation control) control patient. Matching criteria will be by age, gender, diabetic status, attending nephrologist, length of hospitalization stay, and hospital discharge date (to minimize the difference in the date between the case and control). These patients did not have early intervention but followed the usual practice of waiting for the next regularly scheduled dialysis unit labs with anemia management to follow using the regular unit algorithm.
No change from normal routine
Normal unit policy for labs and anemia treatment
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Early anemia diagnosis and treatment
Patients returning to the unit are immediately assessed and treated for anemia
No change from normal routine
Normal unit policy for labs and anemia treatment
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* resumption of routine outpatient chronic hemodialysis within three days of discharge from hospital admission
* enrolled in a facility-based anemia management program
Exclusion Criteria
* previous hospitalization within the past 30 days (ie. patients discharged from a repeat hospitalization)
* anticipated discharge from the outpatient dialysis facility within 30 days (ie anticipated transfer to another facility or hospice)
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fresenius Medical Care North America
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Fresenius Medical Care North America
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Raymond Hakim, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Fresenius Medical Services
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Denver Central
Denver, Colorado, United States
St. John's
Jacksonville, Florida, United States
JAX Beach
Jacksonville, Florida, United States
Prairie
Chicago, Illinois, United States
Tri Counties
Decatur, Indiana, United States
Huntington
Huntington, Indiana, United States
Floyd County
New Albany, Indiana, United States
South Louisville
Louisville, Kentucky, United States
Breaux Bridge
Breaux Bridge, Louisiana, United States
Delta
Delta, Louisiana, United States
East Lafayette
Lafayette, Louisiana, United States
Methuen
Methuen, Massachusetts, United States
Roxbury
Roxbury, Massachusetts, United States
Battle Creek
Battle Creek, Michigan, United States
East Lansing
East Lansing, Michigan, United States
Oshtemo
Kalamazoo, Michigan, United States
Lansing
Lansing, Michigan, United States
Saganaw Riverside
Saginaw, Michigan, United States
Saginaw
Saginaw, Michigan, United States
Eupora
Eupora, Mississippi, United States
Meridian
Meridian, Mississippi, United States
Yokna River
Oxford, Mississippi, United States
Independence Centerpoint
Independence, Missouri, United States
Desert Inn
Las Vegas, Nevada, United States
South Pecos
Las Vegas, Nevada, United States
Briggs Ave
Durham, North Carolina, United States
Freedom Lake
Durham, North Carolina, United States
Boardman
Boardman, Ohio, United States
Cortland
Cortland, Ohio, United States
Elyria
Elyria, Ohio, United States
North Randall
North Randall, Ohio, United States
Westlake
Westlake, Ohio, United States
Willoughby
Willoughby, Ohio, United States
Twin Oaks
Beaverton, Oregon, United States
Clackamas
Clackamas, Oregon, United States
Fresenius Medical Services
Brentwood, Tennessee, United States
Smyrna
Smyrna, Tennessee, United States
West Nashville
West Nashville, Tennessee, United States
North Fort Worth
Fort Worth, Texas, United States
Tarrant County
Fort Worth, Texas, United States
Waco
Waco, Texas, United States
Waco West
Waco, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Wingard RL, Pupim LB, Krishnan M, Shintani A, Ikizler TA, Hakim RM. Early intervention improves mortality and hospitalization rates in incident hemodialysis patients: RightStart program. Clin J Am Soc Nephrol. 2007 Nov;2(6):1170-5. doi: 10.2215/CJN.04261206. Epub 2007 Oct 17.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
20090068
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.