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Upper Endoscopy in CKD&ESRD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04098120
Recruitment Status : Not yet recruiting
First Posted : September 23, 2019
Last Update Posted : September 23, 2019
Sponsor:
Information provided by (Responsible Party):
Nada Abdelsalam Hasan, Assiut University

Brief Summary:
the study is To determine the necessity of upper gastrointestinal endoscopy in CKD(stage III---V) and haemodialyzed patients with upper GIT symptoms

Condition or disease
CKD Stage(III,IV,V) and Haemodialyzed Patients

Detailed Description:

Chronic Kidney disease (CKD) is Kidney damage for ≥3 months, as defined by structural &or functional abnormalities of the kidney, with or without decreased GFR or GFR <60 mL/min/1.73m2 for ≥3 months, with or without kidney damage.

Stage Description GFR (ml/min/1.73 m2) Stage I Kidney damage >90 with normal or ↑ GFR Stage II Kidney damage with 60-89 mild ↓ in GFR Stage III Moderate ↓ in GFR 30-59 Stage IV Severe ↓ in GFR 15-29 Stage V Kidney failure < 15 < 15 (or dialysis) Or on dialysis

- CKD virtually affect the functions of all systems in our human body and associated with several deleterious effects on different systems which is due to multiple risk factors and associated with several abnormalities in the gastrointestinal tract involving all its segments, which include : Esophagitis: is present in more than a the third of the third of cases of uremic patients. It is due to increase of intra-abdominal pressure and reflux. The treatment of these patients is not different from that given to the general population with proton pump inhibitors, once the endoscopic study has been done.

Gastritis and peptic ulcer:as In patients with CKD and haemodialyzed patients, serum levels of gastrin are increased due to increased its secretion and decrease its excretion as it is eliminated by the kidney; additionally, cholecystokinin and secretin may be elevated. Noninvasive tests (H. pylori) have lower sensitivity in CKD so upper endscopy is needed.

In CKD and ESRD patients have more symptoms than general population.Specifically, gastrointestinal distress symptoms and peptic ulcers . The recurrence of peptic ulcer disease (PUD) after Helicobacter pylori eradication is higher in uremic patients than in non-uremic patients, and patients with ESRD have higher complication rates after ulcer development . Therefore, upper endoscopy should be performed in patients with these risk factors more often to prevent severe complications, such as gastrointestinal bleeding ( Haematemesis and melena). Angiodysplasia: affects the microcirculation of the mucosa and sub mucosa of the entire gastrointestinal tract. It is a frequent cause of bleeding in elderly patients, and its incidence is increased in patients on dialysis. Which diagnosed mainly by upper endoscopy as well as for the treatment with hemostasis techniques. The other option is angiography embolization, .

The manifestations of GIT in patients with chronic kidney disease and haemodialyzed patients varies from anorexia,nausea, vomiting they have aprevalance of around 60% )and GIT bleeding and viral hepatitis so it is across sectional study on 60 patients including CKD stage(III---V)and haemodialyzed patients.

  • All patients will be subjected to :
  • Full history and clinical examination . 2) Laboratory tests:

    1. CBC .
    2. liver function testes including PT,PC,INR
    3. blood urea and serum creatinine.
    4. serum calcium and phosphorus
    5. urine analysis. 3) abdominal ultrasonography 4) upper endoscopy

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Upper Gastrointestinal Endoscopic Findings In Chronic Kidney Disease And Haemodialyzed Patients In Assiut University Hospitals
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : October 1, 2021
Estimated Study Completion Date : November 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy




Primary Outcome Measures :
  1. Upper Gastrointestinal Endoscopic Findings In Chronic Kidney Disease And Haemodialyzed Patients [ Time Frame: 2 years ]
    detect upper GIT complications as haematemesis and melena which threatening the life as ealy as possible



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
all CKD patients stage (III---V)and haemodialyzed patients
Criteria

Inclusion Criteria:

1.Patients with age varying from 20 to 60 years . 2.Patients diagnosed as CKD stage III - V and heamodialyzed patients . 3.presenting with upper GIT symptoms e.g anorexia,vomiting,melena…….etc

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Exclusion Criteria:

1.Stage I and Stage II CKD patients. 2.Patients with uremic encephalopathy. 3.Patients undergone Renal transplant . 4.Patients with history of peptic disease. 5. patients on long time therapy with NSAIDs ,steroids. 6.patients with bleeding tendencies and coagulopathy. 7.Chronic alcoholic, Chronic Liver disease .

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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04098120


Contacts
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Contact: nada abdelsalam hasan, doctor 01003562354 nadaabdelsalam63@yahoo.com
Contact: abdella ismail ali, professor 01005432562 abdellahkelani@aun.edy.eg

Sponsors and Collaborators
Assiut University
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Responsible Party: Nada Abdelsalam Hasan, doctor, Assiut University
ClinicalTrials.gov Identifier: NCT04098120    
Other Study ID Numbers: upper endoscopy in CKD&ESRD
First Posted: September 23, 2019    Key Record Dates
Last Update Posted: September 23, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No