CKDNCT04491669
Screening of Gastrointestinal Tract Bleeding Causes Among Chronic Renal Failure Patients
An observational study of CKD and GIT - Gastrointestinal Tract Hemorrhage, run by Assiut University.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- CKD, GIT - Gastrointestinal Tract Hemorrhage
- What is being tested?
- GFR - Glomerular Filtration Rate
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2020to 1 Dec 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- patients with infectious causes of GIT bleeding (Salmonella, Shigella)
- patients with Angiodysplasia.
- patients with Esophageal varices
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- CKD, GIT - Gastrointestinal Tract Hemorrhage
- Being tested
- GFR - Glomerular Filtration Rate
- Medical subject headings
- Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GFR - Glomerular Filtration RateDiagnostic 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of different modalities of therapeutic intervention.
medical therapy up to therapeutic intervention data will be received.
Measured: one year from October 2020 to October 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2020
- Study start1 Oct 2020 (estimated)
- Primary completion1 Oct 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for CKDStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Elsayed Mustafa Hussein Mandour, Assiut University
- Investigators
- Effat AH Tony, Prof. Dr., Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04491669
- Sponsor's protocol ID
- GIT bleeding among CKD
- Status last verified
- Jul 2020
- First submitted
- 25 Jul 2020
- Last updated
- 29 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 20083829Zuccaro 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.
PubMed 9707037Kim 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.
PubMed 25400991Stevens 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.
PubMed 23732715Ishigami 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.
PubMed 30178234
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening of Gastrointestinal Tract Bleeding Causes Among Chronic Renal Failure Patients in Assuit University in a Single Study Center
- ClinicalTrials.gov ID
- NCT04491669
- Acronym / sponsor ID
- GIT bleeding among CKD
- Conditions
- CKD, GIT - Gastrointestinal Tract Hemorrhage
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (estimated)
- Primary completion
- 1 Oct 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 29 Jul 2020 (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 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.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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).
- 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.
Key exclusion criteria (9 listed)
- All Patients with local causes of Gastrointestinal Bleeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GFR - Glomerular Filtration RateChronic 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. | Diagnostic test | – |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2020.
- Background: PubMed 20083829Barkun 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.
- Background: PubMed 9707037Zuccaro 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.
- Background: PubMed 25400991Kim 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.
- Background: PubMed 23732715Stevens 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.
- Background: PubMed 30178234Ishigami 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.
- Individual participant dataSharing planned: No
Related trials for CKD
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
Chronic Kidney Diseases
RecruitingPhase 3
A Phase III Renal Outcomes and Cardiovascular Mortality Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin in Participants With Chronic Kidney Disease and High Blood Pressure
Chronic Kidney Disease and Hypertension
RecruitingObservational study
An Observational Study Called FINEROD to Learn More About the Use of the Treatment Finerenone Including How Safe it is and How Well it Works Under Real-world Conditions
Chronic Kidney Disease, Type 2 Diabetes Mellitus
Recruiting
Transcutaneous Auricular Vagus Nerve Stimulation Device in CKD Population
Chronic Kidney Disease
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.
Effat AH Tony, Prof. Dr. study chair
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of CKD and GIT - Gastrointestinal Tract Hemorrhage, 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 7 inclusion and 9 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 29 Jul 2020. 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 Mahmoud EMH Mandou (00201006810538, m1234mandour@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of different modalities of therapeutic intervention. (time frame: one year from October 2020 to October 2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04491669, which also lists 5 linked publications.
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 29 Jul 2020.