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Other
case control for Anemia
N/A
Waitlist Available
Led By Raymond Hakim, M.D., Ph.D.
Research Sponsored by Fresenius Medical Care North America
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year to accumulate 1500 hospitalizations
Awards & highlights
Study Summary
The investigators hypothesize that the post-hospitalized patient status is characterized by subacute and reversible metabolic and hematological changes that, if addressed and treated in a timely manner, would result in a reduced risk for repeat hospitalization. Consequently, a structured quality improvement program, focused on increasing adherence to company wide anemia management policies (ie hemoglobin monitoring within the first 3-5 days post-hospitalization, followed by an appropriate EPO dose modification within the 7 days post-hospitalization), will significantly decrease the risk of hospital re-admission in the 30 days after discharge.
Eligible Conditions
- Anemia
- Death
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one year to accumulate 1500 hospitalizations
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year to accumulate 1500 hospitalizations
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
composite of death or repeat hospitalization within the 30 days after discharge from a previous hospitalization
Secondary outcome measures
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).
Trial Design
2Treatment groups
Experimental Treatment
Group I: case controlExperimental Treatment1 Intervention
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.
Group II: Early anemia managementExperimental Treatment1 Intervention
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
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Who is running the clinical trial?
Fresenius Medical Care North AmericaLead Sponsor
39 Previous Clinical Trials
76,674 Total Patients Enrolled
1 Trials studying Anemia
48 Patients Enrolled for Anemia
Raymond Hakim, M.D., Ph.D.Principal InvestigatorFresenius Medical Services
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