Screening of Gastrointestinal Tract Bleeding Causes Among Chronic Renal Failure Patients

July 28, 2020 updated by: Mahmoud Elsayed Mustafa Hussein Mandour, Assiut University

Screening of Gastrointestinal Tract Bleeding Causes Among Chronic Renal Failure Patients in Assuit University in a Single Study Center

The aim of the current study is to screen different causes and characteristics of Gastrointestinal bleeding in Chronic Renal Failure patients at Assuit University Hospital according to their stages based on e GFR (Stage I to IV), in order to assess different modalities of therapeutic intervention from medical therapy up to therapeutic intervention.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

  • Chronic Renal Failure is defined as presence of reduced glomerular filtration rate (GFR) < 60 ml/min/ 1.73 m2 and/or evidence of kidney damage (usually indicated by albuminuria or proteinuria) for > 3 months or more irrespective of cause (Kiapidou et al., 2019).
  • Chronic Renal Failure stages are classified according to the National Kidney Foundation in to five stages according to estimated GFR (Ikizler 2009).
  • The prevalence of Chronic Renal Failure is continuously rising in concert with the rising epidemic of its risk factors including ageing, diabetes, obesity, metabolic syndrome, smoking, and hypertension (Stevens and Levin 2013).
  • Gastrointestinal bleeding, is all forms of bleeding in the gastrointestinal tract, from the mouth to the rectum. When there is significant blood loss over a short time, symptoms may include vomiting red blood, vomiting black blood, bloody stool, or black stool. Small amounts of bleeding over a long time may cause iron-deficiency anemia resulting in feeling tired or heart-related chest pain.

Other symptoms may include abdominal pain, shortness of breath, pale skin, or passing out. Sometimes in those with small amounts of bleeding no symptoms may be present. (Bong Sik Matthew Kim. 2014)

• Preliminary data suggest an association between Chronic Renal Failure and Gastrointestinal Bleeding. Individuals with even mild to moderate Chronic Renal Failure warrant clinical attention regarding the risk of hospitalization with Gastrointestinal bleeding. (Kunihiro Matsushita, 2016 Oct 7) reported that the prevalence of Gastrointestinal bleeding was significantly higher in patients with Chronic Renal Failure compared to patients without Chronic Renal Failure.

Study Type

Observational

Enrollment (Anticipated)

100

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

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Chronic Renal Failure patients with different stages (stage I to IV) according to the National Kidney Foundation are recruited from inpatients of renal unit in internal medicine department, Assuit university hospitals.

Description

Inclusion Criteria:

  • One hundred Chronic Renal Failure patients with different stages (stage I to IV) according to the National Kidney Foundation are recruited from inpatients of renal unit in internal medicine department, Assuit university hospitals. Their GFR will assessed by using Chronic Renal Failure EPI equation measured as GFR=166 x(s cr/0.7)-1.209X(0.993)age if female, and GFR=163X(s cr/0.9)-1.209x(0.993)age if male. (Andrews et al 2008).

Chronic Renal Failure staging according to GFR by Chronic Renal Failure EPI is:

  • Stage1 in which GFR>90 mil/min but evidence of kidney damage.
  • Stage 2 GFR 60-89 mil/min.
  • Stage 3 GFR 30-95 mil/min.
  • Stage 4 GFR 15-29 mil/min.
  • Stage 5 GFR<15 mil/min.

Exclusion Criteria:

  • All Patients with local causes of Gastrointestinal Bleeding

    • Benign and Malignant tumors in Gastrointestinal Tract.
    • Patients with Hemorrhoids or anal fissures.
    • Patients with Mallory-Weiss tears.
    • patients with Diverticular disease.
    • patients with Colon polyps.
    • patients with infectious causes of GIT bleeding (Salmonella, Shigella)
    • patients with Angiodysplasia.
    • patients with Esophageal varices

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

Outcome Measure
Measure Description
Time Frame
Assessment of different modalities of therapeutic intervention.
Time Frame: one year from October 2020 to October 2021
medical therapy up to therapeutic intervention data will be received.
one year from October 2020 to October 2021

Collaborators and Investigators

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

Sponsor

Assiut University

Investigators

  • Study Chair: Effat AH Tony, Prof. Dr., Assiut 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 (Anticipated)

October 1, 2020

Primary Completion (Anticipated)

October 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

July 25, 2020

First Submitted That Met QC Criteria

July 28, 2020

First Posted (Actual)

July 29, 2020

Study Record Updates

Last Update Posted (Actual)

July 29, 2020

Last Update Submitted That Met QC Criteria

July 28, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GIT bleeding among CKD

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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