CKD Stage(III,IV,V) and Haemodialyzed PatientsNCT04098120
Upper Endoscopy in CKD&ESRD
An observational study of CKD Stage(III,IV,V) and Haemodialyzed Patients, run by Assiut University.
Trial summary
the study is To determine the necessity of upper gastrointestinal endoscopy in CKD(stage III---V) and haemodialyzed patients with upper GIT symptoms Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- CKD Stage(III,IV,V) and Haemodialyzed Patients
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2019to 1 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Adult
Study population: all CKD patients stage (III---V)and haemodialyzed patients
Who may be able to join
- 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
- -
Who cannot join
- 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 .
- -
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Upper Gastrointestinal Endoscopic Findings In Chronic Kidney Disease And Haemodialyzed Patients In Assiut University Hospitals
the study is To determine the necessity of upper gastrointestinal endoscopy in CKD(stage III---V) and haemodialyzed patients with upper GIT symptoms
Read the 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:
- CBC .
- liver function testes including PT,PC,INR
- blood urea and serum creatinine.
- serum calcium and phosphorus
- urine analysis. 3) abdominal ultrasonography 4) upper endoscopy
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper Gastrointestinal Endoscopic Findings In Chronic Kidney Disease And Haemodialyzed Patients
detect upper GIT complications as haematemesis and melena which threatening the life as ealy as possible
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2019
- Study start1 Oct 2019 (estimated)
- Primary completion1 Oct 2021 (estimated)
- Study completion1 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CKD Stage(III,IV,V) and Haemodialyzed PatientsStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nada Abdelsalam Hasan, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04098120
- Sponsor's protocol ID
- upper endoscopy in CKD&ESRD
- Status last verified
- Sep 2019
- First submitted
- 19 Sep 2019
- Last updated
- 23 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Upper Gastrointestinal Endoscopic Findings In Chronic Kidney Disease And Haemodialyzed Patients In Assiut University Hospitals
- ClinicalTrials.gov ID
- NCT04098120
- Acronym / sponsor ID
- upper endoscopy in CKD&ESRD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (estimated)
- Primary completion
- 1 Oct 2021 (estimated)
- Study completion
- 1 Nov 2021 (estimated)
- First posted
- 23 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
the study is To determine the necessity of upper gastrointestinal endoscopy in CKD(stage III---V) and haemodialyzed patients with upper GIT symptoms
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:
- CBC .
- liver function testes including PT,PC,INR
- blood urea and serum creatinine.
- serum calcium and phosphorus
- urine analysis. 3) abdominal ultrasonography 4) upper endoscopy
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- all CKD patients stage (III---V)and haemodialyzed patients
Key inclusion criteria (2 listed)
- 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
- -
Key exclusion criteria (2 listed)
- 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 .
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2019.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of CKD Stage(III,IV,V) and Haemodialyzed Patients, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact nada abdelsalam hasan, doctor (01003562354, nadaabdelsalam63@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Upper Gastrointestinal Endoscopic Findings In Chronic Kidney Disease And Haemodialyzed Patients (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2019.