Ketoacid Analogues Intradialytic Effect on Inflammation

Hemodialysis Complication Clinical Trial

Official title:

Effect of Intradialytic Administration of Ketoacid Analogues on Inflammatory Parameters in Patients Undergoing Chronic Hemodialysis Twice a Week

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06392516
• Other study ID #: RSF_IPDGH_01
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Hemodialysis Complication
• Inflammation

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