Dialysis Adequacy in Nutritional Status in Hemodialysis Patients

October 25, 2023 updated by: George san dawoud bebawy, Cairo University

Effect of Dialysis Adequacy in Nutritional Status and Quality of Life in Hemodialysis Patients

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Patients with end-stage renal disease (ESRD) are unable to sustain life without hemodialysis. So, adequacy of hemodialysis is the main treatment for this patient.

Adequacy of hemodialysis can be appeared on patient clinically by improve Quality of life and life expectancy, increase appetite and weight gain, control blood pressure, no bone disease, control of acidosis and anemia, Relief of uremic symptoms as nausea, vomiting, fatigue, anorexia, weight loss, muscle cramps, pruritus, or changes in mental status.

Malnutrition is a major issue in patients undergoing hemodialysis and is observed in approximately 20% - 70% of this group. Malnutrition is a serious predictive factor for mortality and morbidity accompanied by an increase in the rate of hospitalization, less physical activity, lower quality of life.

An imbalance between energy and protein gain and food metabolism, metabolic acidosis, dietary restrictions, anorexia and poor appetite, protein and nutrient loss during dialysis, underlying diseases, such as cardiovascular problems, infection, poor nutrition management, inadequate dialysis, etc. are among influencing factors on the nutrition of hemodialysis patients.

Among patients undergoing hemodialysis, 6% to 8% suffer from severe malnutrition and 30% - 65% from mild malnutrition. The results of some studies have shown that one of the important causes of malnutrition is low dialysis adequacy in patients undergoing hemodialysis.

Malnutrition is associated with an increase in morbidity, a decrease in functional capacity, and a greater number and duration of hospital admissions, all of which may cause a low health-related quality of life (QOL) and impact patients' emotional, physical, and psychosocial health.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  1. Patients in regular haemodialysis .
  2. patients above 18 years

Exclusion Criteria:

  1. Patients with thyroid illness.
  2. Patients with acute infection.
  3. Patients with major surgeries.
  4. Patients with malignancy.
  5. Patients with liver cirrhosis.
  6. patient with inflammatory bowel diseases.

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Effect of dialysis adequacy in nutritional status in haemodialysis patients by Body mass index (BMI) and Anthropometric measurements.
Time Frame: baseline

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

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 27, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 25, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 31, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 31, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 25, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • dialysis adequacy

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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