Evaluation of Volume Status Changes in Children on Regular Hemodialysis at Assiut University Children,s Hospital

January 14, 2024 updated by: Ahlam Abelbaset Mohamed, Assiut University
Chronic kidney disease (CKD) is a major health problem worldwide.(1) Chronic renal failure is defined as a decrease in glomerular filtration rate (GFR) of less than 60 ml/min/1.73 m2 of body surface evolving for more than 3 months

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

Chronic kidney disease (CKD) is a major health problem worldwide.(1) Chronic renal failure is defined as a decrease in glomerular filtration rate (GFR) of less than 60 ml/min/1.73 m2 of body surface evolving for more than 3 months . The etiologies of CKD in children are three main groups of pathologies: congenital anomalies of the kidney and urinary tract , hereditary nephropathies and acquired causes . (2) complication of pediatric hemodialysis is chronic fluid overload, left ventricular hypertrophy ,hypertension, heart failure, decrease arterial flexibility and often results in increase chance of morbidity and mortality, So fluid overload must be prevented .(3) Lung ultrasonography is the most recent, safe, easy, and reliable technique . The most commonly observed finding is a comet tail fanning out from the lung-wall interface and spreading upwards to the edge of the screen, named a "B-line" Chest sonar advantages include its noninvasiveness , ease of use, availability of portable machines, avoidance of radiation detect lung edema even in initial non symptomatic cases known as hidden lung congestion .(4) Bioimpedance analysis (BIA) Bio impedance spectroscopy (BIS) is a technique used to estimate total body water, extracellular water, lean and adipose tissue mass and over hydration . (5) N-terminal pro-brain natriuretic peptide is used as a biomarker to aid to predict cardiac dysfunction in children and adolescents .(6)it is an effective marker of volume status in patient with or without reduced ejection fraction undergoing hemodialysis. (7)

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.
50

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

  • Child
  • Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

All cases with end stage renal diseases undergoing regular haemodialysis in nephrology department in a period of two year

Description

Inclusion Criteria:

- Patients aged 3 to 16 years having end stage renal disease undergoing regular haemodialysis for at least more than 6 months of both gender were enrolled

Exclusion Criteria:

  • Patients with chronic lung disease ,or pulmonary infection in the last 2 months were excluded from study.

Patients with congestive heart failure Patients with Pulmonary edema Patient with pericardial effusion parental refusal to participate

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
Evaluation of volume status changes in children on regular hemodialysis at Assiut university children's hospital
Time Frame: two year

Evaluation of Volume status in children on regular haemodialysis by Chest sonar Evaluation of Volume status in children on regular haemodialysis by Chest sonar

Evaluation of Volume status in children on regular haemodialysis by Chest sonar

Evaluation of Volume status in children on regular haemodialysis by Chest sonar Evaluation of Volume status in children on regular haemodialysis by Chest sonar
two year

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.
Assiut University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Professor Mohamed mahrous Eltallawy
Assistant Professor Ahlam Badawy Ali
Lecturer Asmaa Ahmed Mahmoud

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Ahlam Badawy, assist prof, Assiut University
  • Study Director: Asmaa Ahmed, Lecturer, Assiut University

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.
July 1, 2024

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.
July 1, 2026

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.
July 1, 2026

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).
December 21, 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.
December 21, 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.
January 8, 2024

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.
January 17, 2024

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.
January 14, 2024

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.
December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

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.
  • volume status

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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