Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2025-12-26 @ 3:12 AM
Study NCT ID:
NCT05819320
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-17
First Post:
2023-04-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Mucocutaneous Manifestations in Patients With Chronic Kidney Disease inNewVally and Assuit;Hospital Based Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D012877', 'term': 'Skin Manifestations'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-16', 'studyFirstSubmitDate': '2023-04-06', 'studyFirstSubmitQcDate': '2023-04-06', 'lastUpdatePostDateStruct': {'date': '2024-04-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'study the patterns of mucocutaneous disorders in Chronic Kidney Disease patients in Eldakhla General Hospital, New Valley and in Assiut University hospital', 'timeFrame': 'Base line', 'description': 'Comparison of the patterns of mucocutaneous manifestations and their correlation with the different stages of Chronic Kidney Disease in renal unit of internal medicine of Eldakhla general hospital in New Vally and pediatric and adult renal units of Assuit university hospital .'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Kidney Diseases', 'Manifestation, Skin']}, 'referencesModule': {'references': [{'pmid': '33730366', 'type': 'BACKGROUND', 'citation': 'Schonmann Y, Mansfield KE, Mulick A, Roberts A, Smeeth L, Langan SM, Nitsch D. Inflammatory skin diseases and the risk of chronic kidney disease: population-based case-control and cohort analyses. Br J Dermatol. 2021 Oct;185(4):772-780. doi: 10.1111/bjd.20067. Epub 2021 Jun 6.'}, {'pmid': '29441293', 'type': 'BACKGROUND', 'citation': 'Rashpa RS, Mahajan VK, Kumar P, Mehta KS, Chauhan PS, Rawat R, Sharma V. Mucocutaneous Manifestations in Patients with Chronic Kidney Disease: A Cross-sectional Study. Indian Dermatol Online J. 2018 Jan-Feb;9(1):20-26. doi: 10.4103/idoj.IDOJ_160_17.'}, {'pmid': '24115194', 'type': 'BACKGROUND', 'citation': 'Galperin TA, Cronin AJ, Leslie KS. Cutaneous manifestations of ESRD. Clin J Am Soc Nephrol. 2014 Jan;9(1):201-18. doi: 10.2215/CJN.05900513. Epub 2013 Oct 10.'}, {'pmid': '33911288', 'type': 'BACKGROUND', 'citation': 'Goel V, Sil A, Das A. Cutaneous Manifestations of Chronic Kidney Disease, Dialysis and Post-Renal Transplant: A Review. Indian J Dermatol. 2021 Jan-Feb;66(1):3-11. doi: 10.4103/ijd.IJD_502_20.'}]}, 'descriptionModule': {'briefSummary': '1. To study the patterns of mucocutaneous disorders in Chronic Kidney Disease patients in Eldakhla General Hospital, New Valley and in Assiut University hospital .\n2. Comparison of the patterns of mucocutaneous manifestations and their correlation with the different stages of Chronic Kidney Disease in renal unit of internal medicine of Eldakhla general hospital in New Vally and pediatric and adult renal units of Assuit university hospital .', 'detailedDescription': 'Chronic kidney disease (CKD) is defined as abnormalities of kidney structure or function , present for \\> 3 months , with implications for health . chronic kidney disease is classified based on cause , Glomerular Filtration Rate category (G1-G5) , and Albuminuria category ( A1-A3) , abbreviated as CGA . (Michel et al.,2023).\n\nChronic kidney disease (CKD) affects up to 13% of the population and may progress to kidney failure and death. Some risk factors for chronic kidney disease are well known such as high blood pressure and diabetes. There is some evidence that inflammatory skin diseases such as eczema and psoriasis may also increase the risk of chronic kidney disease . (Schonmann et al.,2021).\n\nSkin serves as the mirror of underlying systemic problems. The early diagnosis of subtle cutaneous clinical pointers often helps in identifying renal disorders, obviating the delay in diagnosis and treatment. Cutaneous changes can be observed from the beginning of renal impairment until the evolution to terminal stage . ( Vivek et al,2021) Most patients with severe chronic kidney disease progress to end stage renal disease (ESRD). Cutaneous manifestations are common in all stages of chronic kidney disease particularly towards end stage renal disease . (Rattan et al.,2018).\n\nThe prevalence of chronic kidney disease is increasing, and the incidence and prevalence of associated skin diseases will also increase. Their early recognition and treatment to reduce morbidity and mortality are essential . (Timur et al,2014) Many factors are involved in the pathogenesis of the cutaneous manifestations of end stage renal disease , including electrolyte imbalance, buildup of uremic substances, and comorbid disease (Goldman et al,2012).\n\nThere are two main categories of the cutaneous manifestations of chronic kidney diseases: nonspecific and specific.\n\nNonspecific manifestations include pruritus, skin color changes, xerosis, and half-and-half nails. Specific manifestations include acquired perforating dermatosis, bullous dermatoses, metastatic calcification, and nephrogenic systemic fibrosis. (Goldman et al,2012).\n\nThe pattern of mucocutaneous manifestations of chronic kidney disease in Eldakhla, the New Valley, Egypt, are not studied before.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "All patients with chronic kidney disease attending the renal unit of internal medicine of Eldakhla General hospital, New Vally ,and Assiut University hospital will be included in this study .\n\nDetailed medical history, clinical examination and investigations which support the diagnosis will be recorded including: urine analysis, CBC, Blood urea, creatinine , x- ray, arterial blood gases , abdominal sonography ,serum electrolytes, multislice CT KUB , Demsa scan ......etc .\n\nPotassium hydroxide (KOH) mounts, skin biopsy, Gram's, and Giemsa staining, and bacterial or fungal cultures will be performed when we need.", 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients with chronic kidney disease attending the renal unit of internal medicine of Eldakhla General hospital, New Vally ,and Assiut University hospital will be included in this study within two years and will be examined for any skin manifestations and mucocutaneous findings.\n\nExclusion Criteria:\n\n\\- Human immunodeficiency (HIV) affected persons, renal transplant recipients, and patients with acute renal failure, hepatobiliary, pancreatic, or thyroid disorders, cutaneous or systemic malignancies will be excluded.'}, 'identificationModule': {'nctId': 'NCT05819320', 'briefTitle': 'Mucocutaneous Manifestations in Patients With Chronic Kidney Disease inNewVally and Assuit;Hospital Based Study', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Pattern of Mucocutaneous Manifestations in Patients With Chronic Kidney Disease in New Vally and Assuit (Hospital Based Study) .', 'orgStudyIdInfo': {'id': 'skin manifestations in CKD'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ALdakhla general hospital patients', 'description': 'patterns of mucocutaneous manifestations and their correlation with the different stages of Chronic Kidney Disease in renal unit of internal medicine of Eldakhla general hospital in New Vally', 'interventionNames': ['Other: observe pattern of mucocutaneous manifestations in chronic kidney disease patients']}, {'label': 'Assuit University hospital adult renal unit', 'description': 'patterns of mucocutaneous manifestations and their correlation with the different stages of Chronic Kidney Disease in renal unit of internal medicine of Assuit University hospital (adult renal unit ) .', 'interventionNames': ['Other: observe pattern of mucocutaneous manifestations in chronic kidney disease patients']}, {'label': 'Assuit University hospital pediatric renal unit', 'description': 'patterns of mucocutaneous manifestations and their correlation with the different stages of Chronic Kidney Disease in renal unit of internal medicine of Assuit University hospital (pediatric renal unit ).', 'interventionNames': ['Other: observe pattern of mucocutaneous manifestations in chronic kidney disease patients']}], 'interventions': [{'name': 'observe pattern of mucocutaneous manifestations in chronic kidney disease patients', 'type': 'OTHER', 'description': '1. To study the patterns of mucocutaneous disorders in Chronic Kidney Disease patients .\n2. Comparison of the patterns of mucocutaneous manifestations and their correlation with the different stages of Chronic Kidney Disease', 'armGroupLabels': ['ALdakhla general hospital patients', 'Assuit University hospital adult renal unit', 'Assuit University hospital pediatric renal unit']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Marwa Hassan Mohammed, M,B,B,CH', 'role': 'CONTACT', 'email': 'marwahassan99956@gmail.com', 'phone': '01224456778'}, {'name': 'Marwa Hassan Mohammed, Resident', 'role': 'CONTACT', 'email': 'marwahassan99956@gmail.com', 'phone': '01224456778'}], 'overallOfficials': [{'name': 'Doaa Samir sayed', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Supervisor'}, {'name': 'Eman Mohammed kamal Elsayed Yousef', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Supervisor'}, {'name': 'Marwa Hassan Mohammed', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Investigator'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr Marwa Hassan Mohammed', 'investigatorFullName': 'Marwa Hassan Mohammed Ahmed', 'investigatorAffiliation': 'Assiut University'}}}}