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The goal of this retrospective cohort study is to investigate the effects of compound amino acid capsule on nutrition, calcium and phosphorus metabolism in maintenance hemodialysis(MHD) patients. The main questions it aims to answer are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment group | MHD patients who took compound amino acid capsules regularly(2# tid po) for 9 months | ||
| control group | MHD patients in the control group are selected by PSM with age, sex, dialysis month, baseline BMI, baseline Kt/V and baseline ultrafiltration volume. And they did not take compound amino acid capsules or similar amino acid nutritional supplement for the same 9 months. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline Serum Albumin at 3 months | Change from baseline serum albumin at 3 months of the treatment group and control group are compared. | Data of both groups at baseline and 3 months are collected and analyzed. |
| Change from Baseline Serum Albumin at 6 months | Change from baseline serum albumin at 6 months of the treatment group and control group are compared. | Data of both groups at baseline and 6 months are collected and analyzed. |
| Change from Baseline Serum Albumin at 9 months | Change from baseline serum albumin at 9 months of the treatment group and control group are compared. | Data of both groups at baseline and 9 months are collected and analyzed. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline Prealbumin at 3 months of the treatment group | Within the treatment group, prealbumin at 3 months is compared to baseline. In other words, change from baseline prealbumin at 3 months is compared to 0. | Data of the treatment group at baseline and 3 months are collected and analyzed. |
| Change from Baseline Prealbumin at 3 months of the control group |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events (death in 9 months) | The mortality is compared between the treatment group and the control group within 9 months. | The mortality of both groups in the 9 observational months are collected. |
| Adverse events (cardio-cerebrovascular accidents in 9 months) |
Inclusion Criteria:
Exclusion Criteria:
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maintenance hemodialysis patients
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Renhua Lu, Doctor | Contact | 86-13361958582 | lurenhua1977@hotmail.com |
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Within the control group, prealbumin at 3 months is compared to baseline. In other words, change from baseline prealbumin at 3 months is compared to 0. |
| Data of the control group at baseline and 3 months are collected and analyzed. |
| Change from Baseline Prealbumin at 6 months of the treatment group | Within the treatment group, prealbumin at 6 months is compared to baseline. In other words, change from baseline prealbumin at 6 months is compared to 0. | Data of the treatment group at baseline and 6 months are collected and analyzed. |
| Change from Baseline Prealbumin at 6 months of the control group | Within the control group, prealbumin at 6 months is compared to baseline. In other words, change from baseline prealbumin at 6 months is compared to 0. | Data of the control group at baseline and 6 months are collected and analyzed. |
| Change from Baseline Prealbumin at 9 months of the treatment group | Within the treatment group, prealbumin at 9 months is compared to baseline. In other words, change from baseline prealbumin at 9 months is compared to 0. | Data of the treatment group at baseline and 9 months are collected and analyzed. |
| Change from Baseline Prealbumin at 9 months of the control group | Within the control group, prealbumin at 9 months is compared to baseline. In other words, change from baseline prealbumin at 9 months is compared to 0. | Data of the control group at baseline and 9 months are collected and analyzed. |
| Change from Baseline Hemoglobin at 3 months of the treatment group | Within the treatment group, hemoglobin at 3 months is compared to baseline. In other words, change from baseline hemoglobin at 3 months is compared to 0. | Data of the treatment group at baseline and 3 months are collected and analyzed. |
| Change from Baseline Hemoglobin at 3 months of the control group | Within the control group, hemoglobin at 3 months is compared to baseline. In other words, change from baseline hemoglobin at 3 months compared to 0. | Data of the control group at baseline and 3 months are collected and analyzed. |
| Change from Baseline Hemoglobin at 6 months of the treatment group | Within the treatment group, hemoglobin at 6 months is compared to baseline. In other words, change from baseline hemoglobin at 6 months is compared to 0. | Data of the treatment group at baseline and 6 months are collected and analyzed. |
| Change from Baseline Hemoglobin at 6 months of the control group | Within the control group, hemoglobin at 6 months is compared to baseline. In other words, change from baseline hemoglobin at 6 months is compared to 0. | Data of the control group at baseline and 6 months are collected and analyzed. |
| Change from Baseline Hemoglobin at 9 months of the treatment group | Within the treatment group, hemoglobin at 9 months is compared to baseline. In other words, change from baseline hemoglobin at 9 months is compared to 0. | Data of the treatment group at baseline and 9 months are collected and analyzed. |
| Change from Baseline Hemoglobin at 9 months of the control group | Within the control group, hemoglobin at 9 months is compared to baseline. In other words, change from baseline hemoglobin at 9 months is compared to 0. | Data of the control group at baseline and 9 months are collected and analyzed. |
| Change from Baseline Ferritin at 3 months of the treatment group | Within the treatment group, ferritin at 3 months is compared to baseline. In other words, change from baseline ferritin at 3 months is compared to 0. | Data of the treatment group at baseline and 3 months are collected and analyzed. |
| Change from Baseline Ferritin at 3 months of the control group | Within the control group, ferritin at 3 months is compared to baseline. In other words, change from baseline ferritin at 3 months is compared to 0. | Data of the control group at baseline and 3 months are collected and analyzed. |
| Change from Baseline Ferritin at 6 months of the treatment group | Within the treatment group, ferritin at 6 months is compared to baseline. In other words, change from baseline ferritin at 6 months is compared to 0. | Data of the treatment group at baseline and 6 months are collected and analyzed. |
| Change from Baseline Ferritin at 6 months of the control group | Within the control group, ferritin at 6 months is compared to baseline. In other words, change from baseline ferritin at 6 months is compared to 0. | Data of the control group at baseline and 6 months are collected and analyzed. |
| Change from Baseline Ferritin at 9 months of the treatment group | Within the treatment group, ferritin at 9 months is compared to baseline. In other words, change from baseline ferritin at 9 months is compared to 0. | Data of the treatment group at baseline and 9 months are collected and analyzed. |
| Change from Baseline Ferritin at 9 months of the control group | Within the control group, ferritin at 9 months is compared to baseline. In other words, change from baseline ferritin at 9 months is compared to 0. | Data of the control group at baseline and 9 months are collected and analyzed. |
| Change from Baseline Calcium at 3 months of the treatment group | Within the treatment group, calcium at 3 months is compared to baseline. In other words, change from baseline calcium at 3 months is compared to 0. | Data of the treatment group at baseline and 3 months are collected and analyzed. |
| Change from Baseline Calcium at 3 months of the control group | Within the control group, calcium at 3 months is compared to baseline. In other words, change from baseline calcium at 3 months is compared to 0. | Data of the control group at baseline and 3 months are collected and analyzed. |
| Change from Baseline Calcium at 6 months of the treatment group | Within the treatment group, calcium at 6 months is compared to baseline. In other words, change from baseline calcium at 6 months is compared to 0. | Data of the treatment group at baseline and 6 months are collected and analyzed. |
| Change from Baseline Calcium at 6 months of the control group | Within the control group, calcium at 6 months is compared to baseline. In other words, change from baseline calcium at 6 months is compared to 0. | Data of the control group at baseline and 6 months are collected and analyzed. |
| Change from Baseline Calcium at 9 months of the treatment group | Within the treatment group, calcium at 9 months is compared to baseline. In other words, change from baseline calcium at 9 months is compared to 0. | Data of the treatment group at baseline and 9 months are collected and analyzed. |
| Change from Baseline Calcium at 9 months of the control group | Within the control group, calcium at 9 months is compared to baseline. In other words, change from baseline calcium at 9 months is compared to 0. | Data of the control group at baseline and 9 months are collected and analyzed. |
| Change from Baseline Phosphorus at 3 months of the treatment group | Within the treatment group, phosphorus at 3 months is compared to baseline. In other words, change from baseline phosphorus at 3 months is compared to 0. | Data of the treatment group at baseline and 3 months are collected and analyzed. |
| Change from Baseline Phosphorus at 3 months of the control group | Within the control group, phosphorus at 3 months is compared to baseline. In other words, change from baseline phosphorus at 3 months is compared to 0. | Data of the control group at baseline and 3 months are collected and analyzed. |
| Change from Baseline Phosphorus at 6 months of the treatment group | Within the treatment group, phosphorus at 6 months is compared to baseline. In other words, change from baseline phosphorus at 6 months is compared to 0. | Data of the treatment group at baseline and 6 months are collected and analyzed. |
| Change from Baseline Phosphorus at 6 months of the control group | Within the control group, phosphorus at 6 months is compared to baseline. In other words, change from baseline phosphorus at 6 months is compared to 0. | Data of the control group at baseline and 6 months are collected and analyzed. |
| Change from Baseline Phosphorus at 9 months of the treatment group | Within the treatment group, phosphorus at 9 months is compared to baseline. In other words, change from baseline phosphorus at 9 months is compared to 0. | Data of the treatment group at baseline and 9 months are collected and analyzed. |
| Change from Baseline Phosphorus at 9 months of the control group | Within the control group, phosphorus at 9 months is compared to baseline. In other words, change from baseline phosphorus at 9th month is compared to 0. | Data of the control group at baseline and 9 months are collected and analyzed. |
| Change from Baseline 1,25-(OH) 2-D3 at 3 months of the treatment group | Within the treatment group, 1,25-(OH) 2-D3 at 3 months is compared to baseline. In other words, change from baseline 1,25-(OH) 2-D3 at 3 months is compared to 0. | Data of the treatment group at baseline and 3 months are collected and analyzed. |
| Change from Baseline 1,25-(OH) 2-D3 at 3 months of the control group | Within the control group, 1,25-(OH) 2-D3 at 3 months is compared to baseline. In other words, change from baseline 1,25-(OH) 2-D3 at 3 months is compared to 0. | Data of the control group at baseline and 3 months are collected and analyzed. |
| Change from Baseline 1,25-(OH) 2-D3 at 6 months of the treatment group | Within the treatment group, 1,25-(OH) 2-D3 at 6 months is compared to baseline. In other words, change from baseline 1,25-(OH) 2-D3 at 6 months is compared to 0. | Data of the treatment group at baseline and 6 months are collected and analyzed. |
| Change from Baseline 1,25-(OH) 2-D3 at 6 months of the control group | Within the control group, 1,25-(OH) 2-D3 at 6 months is compared to baseline. In other words, change from baseline 1,25-(OH) 2-D3 at 6 months is compared to 0. | Data of the control group at baseline and 6 months are collected and analyzed. |
| Change from Baseline 1,25-(OH) 2-D3 at 9 months of the treatment group | Within the treatment group, 1,25-(OH) 2-D3 at 9 months is compared to baseline. In other words, change from baseline 1,25-(OH) 2-D3 at 9 months is compared to 0. | Data of the treatment group at baseline and 9 months are collected and analyzed. |
| Change from Baseline 1,25-(OH) 2-D3 at 9 months of the control group | Within the control group, 1,25-(OH) 2-D3 at 9 months is compared to baseline. In other words, change from baseline 1,25-(OH) 2-D3 at 9 months is compared to 0. | Data of the control group at baseline and 9 months are collected and analyzed. |
| Change from Baseline Intact Parathyroid Hormone (iPTH) at 3 months of the treatment group | Within the treatment group, iPTH at 3 months is compared to baseline. In other words, change from baseline iPTH at 3 months is compared to 0. | Data of the treatment group at baseline and 3 months are collected and analyzed. |
| Change from Baseline iPTH at 3 months of the control group | Within the control group, iPTH at 3 months is compared to baseline. In other words, change from baseline iPTH at 3 months is compared to 0. | Data of the control group at baseline and 3 months are collected and analyzed. |
| Change from Baseline iPTH at 6 months of the treatment group | Within the treatment group, iPTH at 6 months is compared to baseline. In other words, change from baseline iPTH at 6 months is compared to 0. | Data of the treatment group at baseline and 6 months are collected and analyzed. |
| Change from Baseline iPTH at 6 months of the control group | Within the control group, iPTH at 6 months is compared to baseline. In other words, change from baseline iPTH at 6 months is compared to 0. | Data of the control group at baseline and 6 months are collected and analyzed. |
| Change from Baseline iPTH at 9 months of the treatment group | Within the treatment group, iPTH at 9 months is compared to baseline. In other words, change from baseline iPTH at 9 months is compared to 0. | Data of the treatment group at baseline and 9 months are collected and analyzed. |
| Change from Baseline iPTH at 9 months of the control group | Within the control group, iPTH at 9 months is compared to baseline. In other words, change from baseline iPTH at 9 months is compared to 0. | Data of the control group at baseline and 9 months are collected and analyzed. |
The incidence of cardio-cerebrovascular accidents is compared between the treatment group and the control group within 9 months. |
| The incidence of cardio-cerebrovascular accidents of both groups in the 9 observational months are collected. |
| Adverse events (vascular access failure in 9 months） | The incidence of vascular access failure is compared between the treatment group and the control group within 9 months. | The incidence of vascular access failure of both groups in the 9 observational months are collected. |
| Drug Safety (liver function-ALT at 9 months) | The alanine transaminase(ALT) level at 9 months is compared between the treatment group and the control group. | Data of the both groups at 9 months are collected and analyzed. |
| Drug Safety (liver function-AST at 9 months) | The aspartate transaminase(AST) level at 9 months is compared between the treatment group and the control group. | Data of the both groups at 9 months are collected and analyzed. |
| Drug Safety (blood lipid-TG at 9 months) | The triglyceride (TG) level at 9 months is compared between the treatment group and the control group. | Data of the both groups at 9 months are collected and analyzed. |
| Drug Safety (blood lipid-TC at 9 months) | The total cholesterol (TC) level at 9 months is compared between the treatment group and the control group. | Data of the both groups at 9 months are collected and analyzed. |
| Drug Safety (blood lipid-LDLC at 9 months) | The low density lipoprotein cholesterol (LDLC) level at 9 months is compared between the treatment group and the control group. | Data of the both groups at 9 months are collected and analyzed. |
| Drug Safety (blood glucose at 9 months) | The random blood glucose level at 9 months is compared between the treatment group and the control group. | Data of the both groups at 9 months are collected and analyzed. |