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This study will compare the clinical outcome of patients with maintenance dialysis room after changing the iron treatment guidelines from original upper limit with ferritin>500ng/ml, or TSAT>20% to Ferritin> 800ng / ml, or TSAT> 50%.
After two years of treatments, we will compare the incidence of clinical events, monthly blood, and biochemical examination data for the two years before and after the change.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Iron Treatment | Experimental | Treatment with iron sucrose with orginal guideline from ferritin>500ng/ml, or TSAT>20% to ferritin>800ng/ml, or TSAT>50%. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| irone sucrose | Drug | drug ingredient: Ferric Hydroxide in complex with sucrose drug dosage form: 270injection/100mg/5ml/Amp |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | the death events following up until 2022 | 2 years |
| coronary artery disease | new onset coronary artery disease diagnosed with electrocardiogram (ST-segment changes, T inversion and Q wave appearance) | 2 years |
| coronary artery disease | Progression of coronary artery disease (SCCT grading increase : 0% = no visible stenosis, 1-24% = minimal stenosis, 25-49% = mild stenosis, 50-69% = moderate stenosis, 70-99% = severe stenosis, 100% = occlusion) | 2 years |
| coronary artery disease | new onset coronary artery disease diagnosed with cardiac enzyme (>troponins I upper limit 99%) | 2 years |
| congestive heart failure | new onset congestive heart failure diagnosed with sonocardiogram (HF-REF, heart failure with reduced EF≦ 35%) | 2 years |
| congestive heart failure | Progression of congestive heart failure (increase of NYHA classification) | 2 years |
| congestive heart failure | new onset congestive heart failure with symptoms (Framingham's clinical criteria: orthopnea, pulmonary rales, S3, paroxysmal nocturnal dyspnea, cough, dyspnea on ordinary exertion, pleural effusion, hepatomegaly, tachycardia with a heart rate over 120 beats/min, bilateral leg edema, and weight loss under 4.5 kg in five days) diagnosed by cardiologists |
| Measure | Description | Time Frame |
|---|---|---|
| diabetes | fasting blood sugar | 2 years |
| diabetes | postprandial blood sugar | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hugo Y Lin, MD, PhD | Contact | 886-7-2911101 | 8737 | yukenlin@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Hugo Y Lin, MD,PhD | Kaohsiung Medical University | Principal Investigator |
| Hugo Y Lin, MD,PhD | Kaohsiung Municipal Ta-Tung Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaohsiung Medical University Hospital | Recruiting | Kaohsiung City | Taiwan |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jul 29, 2019 | Jul 25, 2020 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D000740 | Anemia |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| 2 years |
| congestive heart failure | new onset congestive heart failure (brain natriuretic peptide> 400pg/ml) | 2 yearts |
| diabetes | glycated hemoglobin | 2 years |
| anemia |
| 2 years |
| calcium | serum total calcium level | 2 years |
| phospate | serum phosphate level | 2 years |
| nutrition status | serum albumin level | 2 years |
| liver function | serum AST/ALT level | 2 years |
| liver function | abdominal sonography with Child classification of liver cirrhosis | 2 years |
| sodium | serum sodium level | 2 years |
| potassium | serum potassium level | 2 years |
| parathyroid function | serum parathyroid level | 2 years |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |