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Ketoacid Analogues Intradialytic Effect on Inflammation

NCT ID: NCT06392516

Last Updated: 2024-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-29

Study Completion Date

2024-09-30

Brief Summary

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

Detailed Description

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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

Conditions

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Hemodialysis Complication

Keywords

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ketoacid analogues inflammation hemodialysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

intervention and control
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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control

patient who undergo hemodialysis two times a week

Group Type NO_INTERVENTION

No interventions assigned to this group

intervention

will be given parenteral ketoacid analogues intradialytics two times a week

Group Type EXPERIMENTAL

Ketoacid

Intervention Type DRUG

250 ml ketoacid two hours before the hemodialysis session ended

Interventions

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Ketoacid

250 ml ketoacid two hours before the hemodialysis session ended

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* patient who undergo hemodialysis two times a week

Exclusion Criteria

* travelling hemodialysis
* acute conditions
* HIV patient
* acute infection
* stroke and immobilized patient
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RSUP Fatmawati

OTHER

Sponsor Role lead

Responsible Party

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Anggraini Permata Sari

Internal Medicine Staff, Fellow of Nephrology Division

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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RSUP Fatmawati

Jakarta, Jakarta Selatan, Indonesia

Site Status

Countries

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Indonesia

Facility Contacts

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Anggraini Permata Sari, Internist

Role: primary

Muhammad Ikhsan Mokoagow, Endocrinologist

Role: backup

Other Identifiers

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RSF_IPDGH_01

Identifier Type: -

Identifier Source: org_study_id