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Research Project for Dialysis Patients with a Hgb >13 for 2005. Researched, Edited, and Presented by. Mindy Huttu, Anatole Besarab, and Stan Frinak. Introduction. Why are dialysis patients anemic? - PowerPoint PPT Presentation
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Research Project for Dialysis Patients with a Hgb >13 for 2005 Research Project for Dialysis Patients with a Hgb >13 for 2005
Researched, Edited, and Presented by Researched, Edited, and Presented by
Mindy Huttu, Anatole Besarab, and Stan Frinak Mindy Huttu, Anatole Besarab, and Stan Frinak
Why are dialysis patients anemic?
–Anemia is measured as a reduction in hemoglobin (Hgb), the substance in red blood cells that carries oxygen.
–Chronic Kidney Disease (CKD) patients become anemic as they loose kidney function.
–This results from the loss of the Kidneys’ ability to produce the red blood cell stimulating hormone Erythropoietin (EPO).
–To prevent Anemia, replace EPO produced in the kidney with “artificial” (genetically engineered) EPO.
–Maintaining a near constant Hgb is not easy for doctors and patients to do.
Why are dialysis patients anemic?
–Anemia is measured as a reduction in hemoglobin (Hgb), the substance in red blood cells that carries oxygen.
–Chronic Kidney Disease (CKD) patients become anemic as they loose kidney function.
–This results from the loss of the Kidneys’ ability to produce the red blood cell stimulating hormone Erythropoietin (EPO).
–To prevent Anemia, replace EPO produced in the kidney with “artificial” (genetically engineered) EPO.
–Maintaining a near constant Hgb is not easy for doctors and patients to do.
IntroductionIntroduction
What is Dialysis?What is Dialysis?• Type of therapy used to
provide an artificial replacement for lost kidney function due to kidney failure.
• It is a life maintaining treatment. Dialysis may be used for very sick patients who have suddenly lost their kidney function or for quite stable patients who, over time, have permanently lost their kidney function.
• Type of therapy used to provide an artificial replacement for lost kidney function due to kidney failure.
• It is a life maintaining treatment. Dialysis may be used for very sick patients who have suddenly lost their kidney function or for quite stable patients who, over time, have permanently lost their kidney function.
What is Hemoglobin, (Hgb)?What is Hemoglobin, (Hgb)?
• Hemoglobin is the oxygen-carrying protein in the red blood cells. In vertebrates, it transports oxygen from the lungs to the rest of the body. It also transports carbon dioxide to the lungs for removal.
• Hemoglobin is the oxygen-carrying protein in the red blood cells. In vertebrates, it transports oxygen from the lungs to the rest of the body. It also transports carbon dioxide to the lungs for removal.
What is EPO?What is EPO?
Erythropoietin (EPO) is a glycoprotein hormone that is a growth factor for red blood cell precursors in the bone marrow.
It is produced by the kidney, and is the hormone regulating red blood cell production. It is used in treating anemia resulting from chronic kidney disease or from cancer chemotherapy.
EPO is generally injected under the skin of the patient. Several injections weekly are required for the original forms, but newer long-acting forms (Darbepoetin) may require injections only once every two to four weeks. EPO can also be injected into the blood stream directly. This route of administration is the preferred mode in dialysis patients.
Erythropoietin (EPO) is a glycoprotein hormone that is a growth factor for red blood cell precursors in the bone marrow.
It is produced by the kidney, and is the hormone regulating red blood cell production. It is used in treating anemia resulting from chronic kidney disease or from cancer chemotherapy.
EPO is generally injected under the skin of the patient. Several injections weekly are required for the original forms, but newer long-acting forms (Darbepoetin) may require injections only once every two to four weeks. EPO can also be injected into the blood stream directly. This route of administration is the preferred mode in dialysis patients.
When and how was EPO developed?
When and how was EPO developed?
• First postulated in 1906 based on transfusion experiments in rabbits. In 1950, the still unidentified erythropoietic factor was found to be stimulated in rats breathing a low-oxygen atmosphere.
• In the 1960s its source was identified as the kidneys.
• Human EPO was first purified from human urine by T. Miyake, C. K. Kung and E. Goldwasser at the University of Chicago in 1977.
• EPO has now been identified with a molecular mass of about 30,000 Daltons. It has a 165 amino acid chain with four oligosaccharide side chains and circulates in the blood plasma at about 5 pmol/L.
• First postulated in 1906 based on transfusion experiments in rabbits. In 1950, the still unidentified erythropoietic factor was found to be stimulated in rats breathing a low-oxygen atmosphere.
• In the 1960s its source was identified as the kidneys.
• Human EPO was first purified from human urine by T. Miyake, C. K. Kung and E. Goldwasser at the University of Chicago in 1977.
• EPO has now been identified with a molecular mass of about 30,000 Daltons. It has a 165 amino acid chain with four oligosaccharide side chains and circulates in the blood plasma at about 5 pmol/L.
What is Chronic Kidney Disease?What is Chronic Kidney Disease?
• Chronic kidney disease (CKD) is a slowly progressive loss of kidney function over a period of months or years and quantitated as low glomerular filtration rate.
• CKD that leads to severe illness and requires some form of renal replacement therapy (such as dialysis) is called end-stage renal (kidney) disease (ESRD).
• Chronic kidney disease (CKD) is a slowly progressive loss of kidney function over a period of months or years and quantitated as low glomerular filtration rate.
• CKD that leads to severe illness and requires some form of renal replacement therapy (such as dialysis) is called end-stage renal (kidney) disease (ESRD).
What is Anemia?What is Anemia?• Anemia is the diminution
of red blood cells that contain hemoglobin. This reduces the ability of blood to carry oxygen to the tissues.
• Severity of anemia is measured as a decreased Hgb level below the normal range Male:13 - 18 gm/dL Female:12 - 16 gm/dL
• Anemia is the diminution of red blood cells that contain hemoglobin. This reduces the ability of blood to carry oxygen to the tissues.
• Severity of anemia is measured as a decreased Hgb level below the normal range Male:13 - 18 gm/dL Female:12 - 16 gm/dL
Aims of Study Aims of Study
• Question: How well do doctors regulate the Hgb of dialysis patient’s?
• Method: Examine the trends between EPO dose and Hgb in dialysis patients.
• Goal: Can the data teach us how to do a better job of managing anemia?
• Question: How well do doctors regulate the Hgb of dialysis patient’s?
• Method: Examine the trends between EPO dose and Hgb in dialysis patients.
• Goal: Can the data teach us how to do a better job of managing anemia?
A good correlation between EPO and
HGB level
Hgb and EPO vs TimeHgb and EPO vs Time
Reducing EPO reduces Hgb three months later
Hgb and EPO vs TimeHgb and EPO vs Time
Reducing EPO reduces Hgb three months later
Problems of using EPOProblems of using EPO
• The effect of a given EPO dose can persist for up to 3 months.
• Therefore, a change in EPO dosage may not alter the Hgb level to the desired level for up to several months.
• The effect of a given EPO dose can persist for up to 3 months.
• Therefore, a change in EPO dosage may not alter the Hgb level to the desired level for up to several months.
Defining the ProjectDefining the Project
• Physicians respond to Hgb levels only when limits are exceeded.
• Low Hgb occur for many reasons, most of which are not under the control of the physician.
• High Hgb, however, result from dosing by doctors and medical staff and are potentially modifiable.
• Physicians respond to Hgb levels only when limits are exceeded.
• Low Hgb occur for many reasons, most of which are not under the control of the physician.
• High Hgb, however, result from dosing by doctors and medical staff and are potentially modifiable.
MethodsMethods• Extract Data from data base
• Sort with Access
• Calculate in Excel
• Analyze in StatView and develop graphs and study trends
• Suggest Improvements in dosing strategies
• Extract Data from data base
• Sort with Access
• Calculate in Excel
• Analyze in StatView and develop graphs and study trends
• Suggest Improvements in dosing strategies
Data 2005 Data 2005 Descriptive Statistics Mean Std. Dev. N Min Max
Hgb 12.0 1.63 4878 5.5 18.8
Roll Average 12.1 1.43 1805 6.47 17.17
EPO Dose Corr 6285.4 5188.85 4882 0 28000
FESAT 26.6 9.86 2152 6 85
FERR 438.0 308.3 2153 16 4260
CHR 31.6 2.98 2085 -31.5 46.3
delta Hgb -0.010 1.12 4648 -11.9 11.2
delta time (days) 13.900 9.89 4652 -351 181
slope 0.1 6.62 4647 -78 168
Time to reach 13 72.9 73.66 368 2 322
Time Hgb >13 g 41.3 42.73 372 1.7 257
total duration Hgb >13 81.2 59.71 187 3 273
EPO Increased 2223 2684 610 50 22000
EPO Decreased -1815 2502 810 -22000 -50
Hgb Increase 0.9 0.77 2263 0.1 11
Hgb Decrease -0.95 0.87 2145 -12 -0.1
Hgb Slope Inc (per mo) 2.95 7.24 2262 0.05 168
Hgb Slope dec (per mo) -2.95 4.75 2145 -78 -0.07
Mean SD N Min Max
Rolling Average (Hgb) 12.1 1.43 1805 6.47 17.7
EPO Increase 2223 2684 610 50 22000
EPO decrease - 1815 2502 810 - 22000 - 50
Hgb increase 0.9 0.77 2263 0.1 11
Hgb decrease - 0.95 0.87 2145 - 12 - 0.1
Hgb Slope Inc mo 2.95 7.24 2262 0.05 168
Hgb Slope Dec mo - 2.95 4.75 2145 - 78 - 0.07
Mean SD N Min Max
Rolling Average (Hgb) 12.1 1.43 1805 6.47 17.7
EPO Increase 2223 2684 610 50 22000
EPO decrease - 1815 2502 810 - 22000 - 50
Hgb increase 0.9 0.77 2263 0.1 11
Hgb decrease - 0.95 0.87 2145 - 12 - 0.1
Hgb Slope Inc mo 2.95 7.24 2262 0.05 168
Hgb Slope Dec mo - 2.95 4.75 2145 - 78 - 0.07
Average number of times a patient Hgb exceeded 13 = 1.8 times per year
PercentPercent
Hgb (g/dL)Hgb (g/dL)
0
2
4
6
8
10
12
14
4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20
Hgb Distribution for 2005 207 Patients with a Hgb Value >13 (g/dL)
Hgb Distribution for 2005 207 Patients with a Hgb Value >13 (g/dL)
13≤ Hgb <15 (24%)
Hgb <11 (23%)
Hgb ≥15 (3%)
N = 4862
11≤ Hgb <13 (50%)
Mean Hgb
Mean Hgb
Time (mo)Time (mo)
6
7
8
9
10
11
12
13
14
15
16
0 1 2 3 4 5 6 7 8 9 10 11 12
Mean Hgb measurements for all dialysis patients with a Hgb >13 for 2005 (time in months)
Mean Hgb measurements for all dialysis patients with a Hgb >13 for 2005 (time in months)
(684)
N=(4878)
(445) (467) (442) (313) (541) (355)(222)(492)(336) (279)
(291)
PercentPercent
00
55
1010
1515
2020
2525
- 6- 6 - 4- 4 - 2- 2 00 22 44
N = 4644
Mean = 0.0 ±1.1
Change Hgb (g/dL) Change Hgb (g/dL)
Change in Hgb Between Measurements 2005 DataChange in Hgb Between Measurements 2005 Data
Std. Deviation (±1.12)
Patient Data for Hgb ≤ 13 vs. Hgb > 13Patient Data for Hgb ≤ 13 vs. Hgb > 13
P <.0003
EPO Dose
Mean Diff: 621
0
2000
4000
6000
8000
10000
12000
14000
Hgb > 13
Hgb ≤ 13
6445 5824
Hgb ≤ 13 Hgb > 13
11.3
14.0
0.0
2.0
4.0
6.0
8.0
10.0
12.0
14.0
16.0P <.0001
Hgb
Patient Data for Hgb ≤ 13 vs. Hgb > 13Patient Data for Hgb ≤ 13 vs. Hgb > 13
FESAT
28.325.9
0.0
5.0
10.0
15.0
20.0
25.0
30.0
35.0
40.0
45.0
Hgb > 13Hgb ≤13
P <.0001
FERR
448 412
0
100
200
300
400
500
600
700
800
900
Hgb ≤ 13 Hgb > 13
P <.0154
CHR
31.5 31.9
0.0
5.0
10.0
15.0
20.0
25.0
30.0
35.0
40.0
Hgb > 13
P <.0065
Hgb ≤ 13
Hgb (g/dL)Hgb
(g/dL)
Time (in Days)Time (in Days)
Hgb Values for an Individual Dialysis Patient
Hgb Values for an Individual Dialysis Patient
5
6
7
8
9
10
11
12
13
14
15
16
17
18
0
1000
2000
3000
4000
5000
6000
7000
8000
9000
10000
11000
12000
0 30 60 90 120 150 180 210 240 270 300 330
EPOunitsEPOunits
42 days above Hgb 13
150 days to increase above Hgb 13
77 days above Hgb 13
Suggest Improvements in dosing strategies
Suggest Improvements in dosing strategies
• A patients EPO dose should not be changed every month, because EPO effects can last up to 3 months or more.
• A trend analysis (graph) of the patient’s data may be very useful in making dosing decisions.
• A patients EPO dose should not be changed every month, because EPO effects can last up to 3 months or more.
• A trend analysis (graph) of the patient’s data may be very useful in making dosing decisions.
• A computerized anemia management system that recommends dosing change according to a set protocol could improve results.
• A computerized anemia management system that recommends dosing change according to a set protocol could improve results.
Reducing EPO reduces Hgb three months later
Hemoglobin Distribution
EPO vs. Darbepoetin
UsingComputerized
Anemia Management
Program
Hemoglobin Distribution
EPO vs. Darbepoetin
UsingComputerized
Anemia Management
Program
Pre Dialysis Patients on
Darbepoetin
Last Monthly HGB
N = 265
0
4
8
12
16
20
24P
erc
en
t
5 7 9 11 13 15 17 19 Hgb (g/dL)
63%
0
4
8
12
16
20
24
Pe
rce
nt
5 7 9 11 13 15 17 19
Mean Monthly Hgb g/dL
8.2%
54%
Dialysis Patients on EPO
Mean mo Hgb
2005
N = 2165
• The study showed that an individual patients Hgb can change over a wide range and the Hgb level did not always correspond to the patients EPO dose.
• There are many things other than just the Hgb in which the doctors must look at to decide the amount of EPO which might be right for the patient. The current Hgb level, the current EPO dose and the patients iron status measure by FERR, TSAT, and CHR levels.
• A trend analysis (graph) of the patient’s data may be very useful in making decisions.
• A computerized anemia management program that uses a database to track changes in Hgb and EPO dose may help regulate Hgb levels in dialysis patients.
• The study showed that an individual patients Hgb can change over a wide range and the Hgb level did not always correspond to the patients EPO dose.
• There are many things other than just the Hgb in which the doctors must look at to decide the amount of EPO which might be right for the patient. The current Hgb level, the current EPO dose and the patients iron status measure by FERR, TSAT, and CHR levels.
• A trend analysis (graph) of the patient’s data may be very useful in making decisions.
• A computerized anemia management program that uses a database to track changes in Hgb and EPO dose may help regulate Hgb levels in dialysis patients.
Conclusions Conclusions
ReferencesReferences• http://en.wikipedia.org
• www.facstaff.bucknell.edu/.../Introduction.htm
• http://images.search.yahoo.com/search/images/view?back=http%3A%2F%2Fimages.search.yahoo.com%2Fsearch%2Fimages%3Fp%3Dkidney%2Bdialysis%26rs%3D0%26ei%3DUTF-8%26fr%3DFP-tab-img-t-t400%26vf%3D&w=427&h=331&imgurl=www.ahealthyme.com%2FImagebank%2FMedEco%2F00042705.jpg&rurl=http%3A%2F%2Fwww.ahealthyme.com%2Ftopic%2Fdialysis&size=24.3kB&name=00042705.jpg&p=kidney+dialysis&type=jpeg&no=5&tt=12,773&ei=UTF-8
• ase.tufts.edu/biology/.../index.asp?PP=kidneys
• www.sportujeme.sk
• www.asnanaka.com/m/.../MedicalGlossary/images?D=D
• www.komsta.net/chemwalls/hemoglobin-1280.jpg
• http://en.wikipedia.org/wiki/Hemoglobin
• www.pacifichealth.com/shop/media?M=D
• http://www.henryfordhealth.org/
• http://en.wikipedia.org
• www.facstaff.bucknell.edu/.../Introduction.htm
• http://images.search.yahoo.com/search/images/view?back=http%3A%2F%2Fimages.search.yahoo.com%2Fsearch%2Fimages%3Fp%3Dkidney%2Bdialysis%26rs%3D0%26ei%3DUTF-8%26fr%3DFP-tab-img-t-t400%26vf%3D&w=427&h=331&imgurl=www.ahealthyme.com%2FImagebank%2FMedEco%2F00042705.jpg&rurl=http%3A%2F%2Fwww.ahealthyme.com%2Ftopic%2Fdialysis&size=24.3kB&name=00042705.jpg&p=kidney+dialysis&type=jpeg&no=5&tt=12,773&ei=UTF-8
• ase.tufts.edu/biology/.../index.asp?PP=kidneys
• www.sportujeme.sk
• www.asnanaka.com/m/.../MedicalGlossary/images?D=D
• www.komsta.net/chemwalls/hemoglobin-1280.jpg
• http://en.wikipedia.org/wiki/Hemoglobin
• www.pacifichealth.com/shop/media?M=D
• http://www.henryfordhealth.org/
Data 2005 Data 2005 Descriptive Statistics Mean Std. Dev. N Min Max
Hgb 12.0 1.63 4878 5.5 18.8
Roll Average 12.1 1.43 1805 6.47 17.17
EPO Dose Corr 6285.4 5188.85 4882 0 28000
FESAT 26.6 9.86 2152 6 85
FERR 438.0 308.3 2153 16 4260
CHR 31.6 2.98 2085 -31.5 46.3
delta Hgb -0.010 1.12 4648 -11.9 11.2
delta time (days) 13.900 9.89 4652 -351 181
slope 0.1 6.62 4647 -78 168
Time to reach 13 72.9 73.66 368 2 322
Time Hgb >13 g 41.3 42.73 372 1.7 257
total duration Hgb >13 81.2 59.71 187 3 273
EPO Increased 2223 2684 610 50 22000
EPO Decreased -1815 2502 810 -22000 -50
Hgb Increase 0.9 0.77 2263 0.1 11
Hgb Decrease -0.95 0.87 2145 -12 -0.1
Hgb Slope Inc (per mo) 2.95 7.24 2262 0.05 168
Hgb Slope dec (per mo) -2.95 4.75 2145 -78 -0.07
Mean SD N Min Max
Rolling Average (Hgb) 12.1 1.43 1805 6.47 17.7
EPO Increase 2223 2684 610 50 22000
EPO decrease - 1815 2502 810 - 22000 - 50
Hgb increase 0.9 0.77 2263 0.1 11
Hgb decrease - 0.95 0.87 2145 - 12 - 0.1
Hgb Slope Inc mo 2.95 7.24 2262 0.05 168
Hgb Slope Dec mo - 2.95 4.75 2145 - 78 - 0.07
Mean SD N Min Max
Rolling Average (Hgb) 12.1 1.43 1805 6.47 17.7
EPO Increase 2223 2684 610 50 22000
EPO decrease - 1815 2502 810 - 22000 - 50
Hgb increase 0.9 0.77 2263 0.1 11
Hgb decrease - 0.95 0.87 2145 - 12 - 0.1
Hgb Slope Inc mo 2.95 7.24 2262 0.05 168
Hgb Slope Dec mo - 2.95 4.75 2145 - 78 - 0.07
Average number of times a patient Hgb exceeded 13 = 1.8 times per year