A Study of Compound Amino Acid Capsule on Maintenance Hemodialysis Patients

NCT05874557 | Unknown

• 1 other identifier: IIT-2023-0042
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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. 1.Can compound amino acid capsule improve the nutritional status of MHD patients?
2. 2.Can compound amino acid capsule help to correct the calcium and phosphorus metabolism imbalance of MHD patients?
3. 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).

Conditions

Hemodialysis Complication

Outcome Measures

Primary Outcomes (3)

• 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.

Secondary Outcomes (42)

• Change from Baseline Prealbumin at 3 months of the treatment group

  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

  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

  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

  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

  Data of the treatment group at baseline and 9 months are collected and analyzed.

Other Outcomes (9)

• Adverse events (death in 9 months)

  The mortality of both groups in the 9 observational months are collected.

• Adverse events (cardio-cerebrovascular accidents in 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 of both groups in the 9 observational months are collected.

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

maintenance hemodialysis patients

You may qualify if:

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

You may not qualify if:

• 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;

Sponsors & Collaborators

• RenJi Hospital: lead

Central Study Contacts

Renhua Lu, Doctor

CONTACT

86-13361958582; lurenhua1977@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2023
• First Posted: May 25, 2023
• Study Start: June 1, 2023
• Primary Completion: July 1, 2023
• Study Completion: August 1, 2023
• Last Updated: May 25, 2023

Record last verified: 2023-05