Impact of Adherence to Anemia Management Policy on Repeat Hospitalization in End Stage Renal Disease (ESRD)
|ClinicalTrials.gov Identifier: NCT01017627|
Recruitment Status : Unknown
Verified April 2010 by Fresenius Medical Care North America.
Recruitment status was: Enrolling by invitation
First Posted : November 20, 2009
Last Update Posted : April 2, 2010
|Condition or disease||Intervention/treatment||Phase|
|Anemia Mortality||Other: Early anemia diagnosis and treatment Other: No change from normal routine||Not Applicable|
The post-hospitalization quality improvement project will be piloted across 30 Fresenius clinics. Targeted enrollment of 1500 episodes of hospitalization in which the patient returns after discharge to resume outpatient dialysis.
Patient outcomes will be followed for up to 30 days from the time of discharge from hospital.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1500 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Case Controlled Study to Determine the Impact of Adherence to Anemia Management Policy on Repeat Hospitalization in ESRD|
|Study Start Date :||November 2009|
|Estimated Primary Completion Date :||November 2010|
|Estimated Study Completion Date :||December 2010|
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
Other: Early anemia diagnosis and treatment
Patients returning to the unit are immediately assessed and treated for anemia
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.
Other: No change from normal routine
Normal unit policy for labs and anemia treatment
- composite of death or repeat hospitalization within the 30 days after discharge from a previous hospitalization [ Time Frame: one year to accumulate 1500 hospitalizations ]
- hemoglobin, transferrin saturation, albumin, white blood cell count, and C-reactive protein* levels measured in the period following hospitalization and change relative to values measured prior to hospitalization (where available). [ Time Frame: one year to accumulate 1500 hospitalizations ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01017627
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|Principal Investigator:||Raymond Hakim, M.D., Ph.D.||Fresenius Medical Services|