NCT06108856

Brief Summary

Assess nutrition status in hemodialysis patients and effect adequacy of hemodialysis on it. Effect of dialysis adequacy and nutritional status in patients' quality of life.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 27, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 31, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

October 31, 2023

Status Verified

October 1, 2023

Enrollment Period

1 year

First QC Date

September 27, 2023

Last Update Submit

October 25, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Effect of dialysis adequacy in nutritional status in haemodialysis patients by Body mass index (BMI) and Anthropometric measurements.

    assess how dialysis adequacy affect nutritional status using : 1. Body mass index (BMI) : calculated based on the weight (kg)/height (m2) formula as it divide into : 1. underweight (BMI \< 18.5) worse outcome 2. normal weight (BMI from 18.5 to 25) better outcome . 3. overweight (BMI = 25 - 30). 4. obese (BMI \>30) . b)Anthropometric measurements : <!-- --> 1. weight in kilograms . 2. height in meters. 3. waist circumference in centimeters. 4. hip circumference in centimeters. 5. mid arm circumference in centimeters.

    baseline

Interventions

machine by which people undergo dialysis on it.

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patient on regular hemodialysis above 18 years without acute infection, major surgeries, recent trauma, or liver cirrhosis.

You may qualify if:

  • Patients in regular haemodialysis .
  • patients above 18 years

You may not qualify if:

  • Patients with thyroid illness.
  • Patients with acute infection.
  • Patients with major surgeries.
  • Patients with malignancy.
  • Patients with liver cirrhosis.
  • patient with inflammatory bowel diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Kutsal DA, Kursat S, Inci A, Ulman C, OzanUtuk I. The relationship between malnutrition subgroups and volume parameters in pre-dialysis patients. Saudi J Kidney Dis Transpl. 2016 Jan;27(1):81-7. doi: 10.4103/1319-2442.174082.

    PMID: 26787571BACKGROUND
  • Chan M, Kelly J, Batterham M, Tapsell L. Malnutrition (subjective global assessment) scores and serum albumin levels, but not body mass index values, at initiation of dialysis are independent predictors of mortality: a 10-year clinical cohort study. J Ren Nutr. 2012 Nov;22(6):547-57. doi: 10.1053/j.jrn.2011.11.002. Epub 2012 Mar 9.

    PMID: 22406122BACKGROUND

Central Study Contacts

george san, Bachelor's

CONTACT

Mona soliman, professer

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 27, 2023

First Posted

October 31, 2023

Study Start

December 1, 2023

Primary Completion

December 1, 2024

Study Completion

January 1, 2025

Last Updated

October 31, 2023

Record last verified: 2023-10