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An observational study of the effects of dialysis whole-nutrient fluid in patients with regular hemodialysis

An observational study of the effects of dialysis whole-nutrient fluid in patients with regular hemodialysis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000034184
Enrollment
Unknown
Registered
2020-06-27
Start date
2020-06-29
Completion date
Unknown
Last updated
2020-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic kidney disease

Interventions

experimental group:Oral supplement nephropathy dialytic total nutrient fluid and lifestyle guidance
control gorup:Lifestyle guidance

Sponsors

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Regular hemodialysis patient, Blood Purification Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology. At least two of the following 3-9 items are met. If any of the other items are not met, they will not be included: 1. Patients with CKD who meet hemodialysis criteria between the ages of 18 ~ 75 years (including 18 and 75 years old) (the proportion of subjects of either sex is not less than 1/3); 2. Body mass index (BMI) = 5% within 3 months or >= 10% within 6 months; 4. Muscle mass reduction, >= 5% in 3 months or >= 10% in 6 months; 5. Serum albumin < 38g/L; 6. Serum prealbumin < 300mg/L; 7. Serum cholesterol level < 2.86mmol/L; 8. Protein intake of maintenance dialysis patients with no specific cause <0.8g/Kg/d for at least 2 months; 9. Unconscious low dietary energy intake <25Kcal/kg/d for at least 2 months; 10. Subjects should be willing to take appropriate contraceptive measures to avoid pregnancy between the study period and 1 month after the end of the study period; 11. The subjects understand and follow the study procedure, participate voluntarily, and sign the informed consent.

Exclusion criteria

Exclusion criteria: If any of the following is: 1. Participated in other clinical trials within 3 months before the trial; 2. Allergic constitution, such as allergic to drugs or food;Or those who are known to be allergic to the ingredients in ONS for this study; 3. Persons with severe heart and liver diseases or other acute digestive tract diseases or respiratory diseases, and persons with systemic diseases such as blood, endocrine, nervous and mental diseases; 4. Gastrointestinal and liver diseases that affect food absorption or metabolism (e.g., liver, kidney or gastrointestinal partial resection); 5. Acute diseases occurred during the pre-study screening stage or before the study medication; 6. Pregnant and lactating women; 7. Those who are unable to use effective contraception or who have had family planning for six months; 8. Taking other ONS preparations during the study; 9. Any subjects who, in the investigator's judgment, have reduced likelihood of inclusion (e.g. weak body, etc.), have a tendency to disobey during the study period, or have other lesions that complicate inclusion.

Design outcomes

Primary

MeasureTime frame
Body composition measurement;serum albumin;anthropometric measuring;Grip strength;

Secondary

MeasureTime frame
Quality of Life survey;

Countries

China

Contacts

Public ContactYing Yao

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

yaoyingkk@126.com+86 13720379867

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026