Ketoacid Analogues Intradialytic Effect on Inflammation

April 26, 2024 updated by: Anggraini Permata Sari, RSUP Fatmawati

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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

Study Type

Interventional

Enrollment (Estimated)

86

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control
patient who undergo hemodialysis two times a week
Experimental: intervention
will be given parenteral ketoacid analogues intradialytics two times a week
Drug: Ketoacid
250 ml ketoacid two hours before the hemodialysis session ended

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
interleukin-6
Time Frame: 12 weeks
in pg/mL, no limit values
12 weeks
malnutrition inflammation score
Time Frame: 12 weeks
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
Time Frame: 12 weeks
the percentage ratio of neutrophil count and lymphocyte count will be combined to neutrophil lymphocyte ratio
12 weeks
monocyte lymphocyte ratio
Time Frame: 12 weeks
the percentage ratio of monocyte count and lymphocyte count will be combined to monocyte lymphocyte ratio
12 weeks
thrombocyte lymphocyte ratio
Time Frame: 12 weeks
the percentage ratio of thrombocyte (in per microliter of blood) and lymphocyte count will be combined to thrombocyte lymphocyte ratio
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RSUP Fatmawati

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 29, 2024

Primary Completion (Estimated)

August 31, 2024

Study Completion (Estimated)

September 30, 2024

Study Registration Dates

First Submitted

April 23, 2024

First Submitted That Met QC Criteria

April 26, 2024

First Posted (Actual)

April 30, 2024

Study Record Updates

Last Update Posted (Actual)

April 30, 2024

Last Update Submitted That Met QC Criteria

April 26, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RSF_IPDGH_01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

the data is restricted only for investigators

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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