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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06392516
Other study ID # RSF_IPDGH_01
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 29, 2024
Est. completion date September 30, 2024

Study information

Verified date April 2024
Source RSUP Fatmawati
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

this study tries to measure the effect of intradialytic ketoacid analogues on inflammatory parameters


Description:

this study will measure inflammation parameters: - interleukin 6 - malnutrition inflammation score - neutrophil lymphocyte ratio - monocyte lymphocyte ratio - thrombocyte lymphocyte ratio the duration of intervention is 12 weeks


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 86
Est. completion date September 30, 2024
Est. primary completion date August 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - patient who undergo hemodialysis two times a week Exclusion Criteria: - travelling hemodialysis - acute conditions - HIV patient - acute infection - stroke and immobilized patient

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Ketoacid
250 ml ketoacid two hours before the hemodialysis session ended

Locations

Country Name City State
Indonesia RSUP Fatmawati Jakarta Jakarta Selatan

Sponsors (1)

Lead Sponsor Collaborator
RSUP Fatmawati

Country where clinical trial is conducted

Indonesia, 

Outcome

Type Measure Description Time frame Safety issue
Primary interleukin-6 in pg/mL, no limit values 12 weeks
Primary malnutrition inflammation score consists of ten components, based on subjective complaints combined with albumin serum (in g/dL), serum iron (in micromol/L, and total iron binding capacity (in micromol/L). the sum of all components >5 means have high inflammation status 12 weeks
Primary neutrophil lymphocyte ratio the percentage ratio of neutrophil count and lymphocyte count will be combined to neutrophil lymphocyte ratio 12 weeks
Primary monocyte lymphocyte ratio the percentage ratio of monocyte count and lymphocyte count will be combined to monocyte lymphocyte ratio 12 weeks
Primary thrombocyte lymphocyte ratio the percentage ratio of thrombocyte (in per microliter of blood) and lymphocyte count will be combined to thrombocyte lymphocyte ratio 12 weeks
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