AnemiaNCT01017627
Impact of Adherence to Anemia Management Policy on Repeat Hospitalization in End Stage Renal Disease (ESRD)
A study testing Early anemia diagnosis and treatment and No change from normal routine in people with Anemia and Mortality, run by Fresenius Medical Care North America at 42 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Early anemia diagnosis and treatment and No change from normal routine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 42 sitesUnited States
- Study dates
- Nov 2009to Dec 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age ≥ 18
- resumption of routine outpatient chronic hemodialysis within three days of discharge from hospital admission
- enrolled in a facility-based anemia management program
Who cannot join
- 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)
Trial locations and contacts
42 sites in 1 country.
42 sites in 1 country
United States42 sites
Battle Creek
Battle Creek, Michigan, 49014
Twin Oaks
Beaverton, Oregon, 97006
Boardman
Boardman, Ohio, 44512
Breaux Bridge
Breaux Bridge, Louisiana, 70517
Fresenius Medical Services
Brentwood, Tennessee, 37027
Prairie
Chicago, Illinois, 60616
Clackamas
Clackamas, Oregon, 97015
Cortland
Cortland, Ohio, 44410
Tri Counties
Decatur, Indiana, 46733
Delta
Delta, Louisiana, 71233
Denver Central
Denver, Colorado, 80209
Briggs Ave
Durham, North Carolina, 27703
Freedom Lake
Durham, North Carolina, 27704
East Lansing
East Lansing, Michigan, 48823
Elyria
Elyria, Ohio, 44035
Eupora
Eupora, Mississippi, 39744
North Fort Worth
Fort Worth, Texas, 76119
Tarrant County
Fort Worth, Texas, 76119
Huntington
Huntington, Indiana, 46750
Independence Centerpoint
Independence, Missouri, 64057
St. John's
Jacksonville, Florida, 32246
JAX Beach
Jacksonville, Florida, 32250
Oshtemo
Kalamazoo, Michigan, 49009
East Lafayette
Lafayette, Louisiana, 70501
Lansing
Lansing, Michigan, 48911
Desert Inn
Las Vegas, Nevada, 89109
South Pecos
Las Vegas, Nevada, 89120
South Louisville
Louisville, Kentucky, 40216
Meridian
Meridian, Mississippi, 39301
Methuen
Methuen, Massachusetts, 01844
Floyd County
New Albany, Indiana, 47150
North Randall
North Randall, Ohio, 44128
Yokna River
Oxford, Mississippi, 38655
Roxbury
Roxbury, Massachusetts, 02119
Saganaw Riverside
Saginaw, Michigan, 48602
Saginaw
Saginaw, Michigan, 48602
Smyrna
Smyrna, Tennessee, 37167
Waco
Waco, Texas, 76708
Waco West
Waco, Texas, 76712
West Nashville
West Nashville, Tennessee, 37209
Westlake
Westlake, Ohio, 44145
Willoughby
Willoughby, Ohio, 44094
About this study
Official title: A Case Controlled Study to Determine the Impact of Adherence to Anemia Management Policy on Repeat Hospitalization in ESRD
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.
Read the 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.
- Being tested
- Early anemia diagnosis and treatment, No change from normal routine
- Keywords
- ESRD, Anemia, Hospitalizations, Mortality
- Medical subject headings
- Anemia, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early anemia diagnosis and treatmentOther
Patients returning to the unit are immediately assessed and treated for anemia
No change from normal routineOther
Normal unit policy for labs and anemia treatment
| Study group | Role | What they receive |
|---|---|---|
| Early anemia management | Other | 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 Receives: Other: Early anemia diagnosis and treatment |
| case control | Other | 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. Receives: Other: No change from normal routine |
What is being measured
The primary outcome is the main question the study is designed to answer.
composite of death or repeat hospitalization within the 30 days after discharge from a previous hospitalization
Measured: one year to accumulate 1500 hospitalizations
Secondary outcomes (1)
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).
Measured: one year to accumulate 1500 hospitalizations
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionNov 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fresenius Medical Care North America
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Raymond Hakim, M.D., Ph.D., Principal investigator, Fresenius Medical Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01017627
- Sponsor's protocol ID
- 20090068
- Status last verified
- Apr 2010
- First submitted
- 18 Nov 2009
- Last updated
- 2 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 17942761
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Case Controlled Study to Determine the Impact of Adherence to Anemia Management Policy on Repeat Hospitalization in ESRD
- ClinicalTrials.gov ID
- NCT01017627
- Acronym / sponsor ID
- 20090068
- Keywords
- ESRD, Anemia, Hospitalizations, Mortality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Fresenius Medical Care North AmericaIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Nov 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 20 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early anemia management | Other | Other: Early anemia diagnosis and treatmentUpon 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 |
| case control | Other | Other: No change from normal routineEach 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age ≥ 18
- resumption of routine outpatient chronic hemodialysis within three days of discharge from hospital admission
- enrolled in a facility-based anemia management program
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early anemia diagnosis and treatmentPatients returning to the unit are immediately assessed and treated for anemia | Other | Early anemia management |
| No change from normal routineNormal unit policy for labs and anemia treatment | Other | case control |
Primary outcome
composite of death or repeat hospitalization within the 30 days after discharge from a previous hospitalization
Time frame: one year to accumulate 1500 hospitalizations
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2010.
- Background: PubMed 17942761Wingard 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raymond Hakim, M.D., Ph.D. principal investigator
Fresenius Medical Services
42 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early anemia diagnosis and treatment and No change from normal routine in people with Anemia and Mortality, run by Fresenius Medical Care North America at 42 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
composite of death or repeat hospitalization within the 30 days after discharge from a previous hospitalization (time frame: one year to accumulate 1500 hospitalizations). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01017627, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2010.