A Study of Compound Amino Acid Capsule on Maintenance Hemodialysis Patients

NCT ID: NCT05874557

Last Updated: 2023-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-30

Study Completion Date

2023-08-31

Brief Summary

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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:

1. Can compound amino acid capsule improve the nutritional status of MHD patients?
2. Can compound amino acid capsule help to correct the calcium and phosphorus metabolism imbalance of MHD patients?
3. Is compound amino acid capsule safe for MHD patients? We will collect the medical history and laboratory data of MHD patients who regularly took compound amino acid capsule for 9 months or did not use the same preparation in previous medical experience. We focus on the difference of serum albumin level between the treatment group and the control group within 9 months, as well as prealbumin, hemoglobin, ferritin, calcium, phosphorus, 1,25-OH 2-D3 and intact parathyroid hormone (iPTH).

Detailed Description

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Conditions

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Hemodialysis Complication

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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treatment group

MHD patients who took compound amino acid capsules regularly(2# tid po) for 9 months

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients who received maintenance hemodialysis (≥ 3 months) in Renji Hospital;
* Regularly participate in the routine laboratory examination of the hemodialysis center every 3 months;

Exclusion Criteria

* Severe heart failure (NYHA III/IV);
* Human immunodeficiency virus positive or is suffering from other serious infectious diseases;
* Have a history of malignant tumor;
* Women during pregnancy or lactation;
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RenJi Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Renhua Lu, Doctor

Role: CONTACT

86-13361958582

Other Identifiers

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IIT-2023-0042

Identifier Type: -

Identifier Source: org_study_id

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