Screening of Gastrointestinal Tract Bleeding Causes Among Chronic Renal Failure Patients

NCT04491669 | Unknown

• 1 other identifier: GIT bleeding among CKD
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

CKD; GIT - Gastrointestinal Tract Hemorrhage

Outcome Measures

Primary Outcomes (1)

• Assessment of different modalities of therapeutic intervention.

  medical therapy up to therapeutic intervention data will be received.

  one year from October 2020 to October 2021

Interventions

GFR - Glomerular Filtration Rate DIAGNOSTIC_TEST

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (5)

• Barkun AN, Bardou M, Kuipers EJ, Sung J, Hunt RH, Martel M, Sinclair P; International Consensus Upper Gastrointestinal Bleeding Conference Group. International consensus recommendations on the management of patients with nonvariceal upper gastrointestinal bleeding. Ann Intern Med. 2010 Jan 19;152(2):101-13. doi: 10.7326/0003-4819-152-2-201001190-00009.

  PMID: 20083829 BACKGROUND

• Zuccaro G Jr. Management of the adult patient with acute lower gastrointestinal bleeding. American College of Gastroenterology. Practice Parameters Committee. Am J Gastroenterol. 1998 Aug;93(8):1202-8. doi: 10.1111/j.1572-0241.1998.00395.x. No abstract available.

  PMID: 9707037 BACKGROUND

• Kim BS, Li BT, Engel A, Samra JS, Clarke S, Norton ID, Li AE. Diagnosis of gastrointestinal bleeding: A practical guide for clinicians. World J Gastrointest Pathophysiol. 2014 Nov 15;5(4):467-78. doi: 10.4291/wjgp.v5.i4.467.

  PMID: 25400991 BACKGROUND

• Stevens PE, Levin A; Kidney Disease: Improving Global Outcomes Chronic Kidney Disease Guideline Development Work Group Members. Evaluation and management of chronic kidney disease: synopsis of the kidney disease: improving global outcomes 2012 clinical practice guideline. Ann Intern Med. 2013 Jun 4;158(11):825-30. doi: 10.7326/0003-4819-158-11-201306040-00007.

  PMID: 23732715 BACKGROUND

• Ishigami J, Matsushita K. Clinical epidemiology of infectious disease among patients with chronic kidney disease. Clin Exp Nephrol. 2019 Apr;23(4):437-447. doi: 10.1007/s10157-018-1641-8. Epub 2018 Sep 3.

  PMID: 30178234 BACKGROUND

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Interventions

Glomerular Filtration Rate

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Kidney Function Tests; Diagnostic Techniques, Urological; Diagnostic Techniques and Procedures; Diagnosis; Urinary Tract Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Officials

• Effat AH Tony, Prof. Dr.

  Assiut University

  STUDY CHAIR

Central Study Contacts

Mahmoud EMH Mandou

CONTACT

00201006810538; m1234mandour@outlook.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: July 25, 2020
• First Posted: July 29, 2020
• Study Start: October 1, 2020
• Primary Completion: October 1, 2021
• Study Completion: December 1, 2021
• Last Updated: July 29, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share