Ketoacid Analogues Intradialytic Effect on Inflammation

NCT06392516 | Not Yet Recruiting

• 1 other identifier: RSF_IPDGH_01
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hemodialysis Complication

Keywords

ketoacid analogues; inflammation; hemodialysis

Outcome Measures

Primary Outcomes (5)

• interleukin-6

  in pg/mL, no limit values

  12 weeks

• 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

• neutrophil lymphocyte ratio

  the percentage ratio of neutrophil count and lymphocyte count will be combined to neutrophil lymphocyte ratio

  12 weeks

• monocyte lymphocyte ratio

  the percentage ratio of monocyte count and lymphocyte count will be combined to monocyte lymphocyte ratio

  12 weeks

• 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

Study Arms (2)

control

NO INTERVENTION

patient who undergo hemodialysis two times a week

intervention

EXPERIMENTAL

will be given parenteral ketoacid analogues intradialytics two times a week

Drug: Ketoacid

Interventions

Ketoacid DRUG

250 ml ketoacid two hours before the hemodialysis session ended

intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patient who undergo hemodialysis two times a week

You may not qualify if:

• travelling hemodialysis
• acute conditions
• HIV patient
• acute infection
• stroke and immobilized patient

Sponsors & Collaborators

• RSUP Fatmawati: lead

Study Sites (1)

RSUP Fatmawati

Jakarta, Jakarta Selatan, 12430, Indonesia

Location

MeSH Terms

Conditions

Inflammation

Interventions

Keto Acids

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Internal Medicine Staff, Fellow of Nephrology Division

Model Details: intervention and control

Study Record Dates

• First Submitted: April 23, 2024
• First Posted: April 30, 2024
• Study Start: April 29, 2024
• Primary Completion: August 31, 2024
• Study Completion: September 30, 2024
• Last Updated: April 30, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)