Skip to main content
Clinical Trials/NCT01017627
NCT01017627
Unknown
Not Applicable

A Case Controlled Study to Determine the Impact of Adherence to Anemia Management Policy on Repeat Hospitalization in ESRD

Fresenius Medical Care North America42 sites in 1 country1,500 target enrollmentNovember 2009
ConditionsAnemiaMortality

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anemia
Sponsor
Fresenius Medical Care North America
Enrollment
1500
Locations
42
Primary Endpoint
composite of death or repeat hospitalization within the 30 days after discharge from a previous hospitalization
Last Updated
16 years ago

Overview

Brief 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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
November 2009
End Date
December 2010
Last Updated
16 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Eligibility Criteria

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

  • enrolled in hospice
  • 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)

Outcomes

Primary Outcomes

composite of death or repeat hospitalization within the 30 days after discharge from a previous hospitalization

Time Frame: one year to accumulate 1500 hospitalizations

Secondary Outcomes

  • 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).(one year to accumulate 1500 hospitalizations)

Study Sites (42)

Loading locations...

Similar Trials