Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT05147818
Status:
UNKNOWN
Last Update Posted:
2021-12-07
First Post:
2021-11-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Risk Factors for Acute Kidney Injury in Diabetic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2023-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-11-27', 'studyFirstSubmitDate': '2021-11-27', 'studyFirstSubmitQcDate': '2021-11-27', 'lastUpdatePostDateStruct': {'date': '2021-12-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Identify risk factors for Acute kidney injury in diabetic patients', 'timeFrame': '2 years', 'description': 'Identify risk factors for Acute kidney injury in d iabetic patients'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabete Mellitus']}, 'referencesModule': {'references': [{'pmid': '25537714', 'type': 'BACKGROUND', 'citation': 'American Diabetes Association. (2) Classification and diagnosis of diabetes. Diabetes Care. 2015 Jan;38 Suppl:S8-S16. doi: 10.2337/dc15-S005. No abstract available.'}, {'pmid': '26670418', 'type': 'BACKGROUND', 'citation': 'Aziz Z, Absetz P, Oldroyd J, Pronk NP, Oldenburg B. A systematic review of real-world diabetes prevention programs: learnings from the last 15 years. Implement Sci. 2015 Dec 15;10:172. doi: 10.1186/s13012-015-0354-6.'}, {'pmid': '23619194', 'type': 'BACKGROUND', 'citation': 'Mima A. Diabetic nephropathy: protective factors and a new therapeutic paradigm. J Diabetes Complications. 2013 Sep-Oct;27(5):526-30. doi: 10.1016/j.jdiacomp.2013.03.003. Epub 2013 Apr 22.'}, {'pmid': '26251707', 'type': 'BACKGROUND', 'citation': "Bienholz A, Wilde B, Kribben A. From the nephrologist's point of view: diversity of causes and clinical features of acute kidney injury. Clin Kidney J. 2015 Aug;8(4):405-14. doi: 10.1093/ckj/sfv043. Epub 2015 Jul 9."}, {'pmid': '33547417', 'type': 'BACKGROUND', 'citation': 'DeFronzo RA, Reeves WB, Awad AS. Pathophysiology of diabetic kidney disease: impact of SGLT2 inhibitors. Nat Rev Nephrol. 2021 May;17(5):319-334. doi: 10.1038/s41581-021-00393-8. Epub 2021 Feb 5.'}]}, 'descriptionModule': {'briefSummary': 'incidence of AKI in diabetic patients seems to be influenced by multiple risk Factors like severe infections, elderly, poor diabetic control, previous AKI, chronic kidney disease and drugs like SGLT2-I increase risk of AKI in diabetic patients.', 'detailedDescription': 'The incidence and prevalence of diabetes mellitus (DM) have increased over the last 20 years. The defining feature of diabetes mellitus (DM) is the presence of hyperglycaemia . mostly due to the progressively increasing prevalence of obesity and the metabolic syndrome, Current prevalence of DM worldwide is estimated to be about 390 million people . The Cardiovascular complications increase morbidity and mortality in diabetic patients. About 40% of end-stage renal disease on regular dialysis are diabetic . Acute kidney injury (AKI) Is a fundamental problem in hospitalized patients; its incidence has been reaching 20% in middle-Europe . About 50% of patients presented with AKI are found to be diabetic ; which may indicate a direct relationship between the two conditions. In 2012, a clinical practice guideline published by Kidney Disease: Improving Global Outcomes (KDIGO) provided a unifying definition and staging system for AKI . On the other hand, incidence of AKI in diabetic patients seems to be influenced by multiple risk Factors like severe infections, elderly, poor diabetic control, previous AKI, chronic kidney disease and drugs like SGLT2-I increase risk of AKI in diabetic patients. We aim in this study to identify the most common risk factors for AKI in diabetic patients and how those risk factors affect morbidity and mortality in patients with DM who developed AKI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients aged from 18 year and older Diabetic patients.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\-\n\nInclusion criteria for the cases :\n\n200 Diabetic patients of 18 year and older (either type 1or 2) presented by AKI based on KIDIGO Definition \\& Staging. KDIGO definition of AKI: Increase in serum creatinine by ≥0.3 mg/dL (≥26.5 µmol/L) within 48 h, or Increase in serum creatinine to ≥1.5 times baseline that is known or presumed to have occurred within the prior 7 days, or Urine volume \\<0.5 mL/kg/h for 6 h.\n\nKDIGO staging of AKI: (1) stage 1: Serum creatinine 1.5-1.9 × baseline or ≥0.3 mg/dL (≥26.5 µmol/L) increase / Urine output \\<0.5 mL/kg/h for 6-12 h (2) stage 2; Serum creatinine 2.0-2.9 × baseline / Urine output \\<0.5 mL/kg/h for ≥12 h (3) stage 3: Serum creatinine 3.0 × baseline, increase in serum creatinine to ≥4.0 mg/dL (≥353.6 µmol/L), initiation of renal replacement therapy, or, in patients \\<18 years, decrease in eGFR to \\<35 mL/min per 1.73 m2 / Urine output \\<0.3 mL/kg/h for ≥24 h or anuria for ≥12 h .\n\nInclusion criteria for matched controls 200 Diabetic patients of 18 year and older with no AKI (either type 1or 2)\n\nExclusion Criteria:\n\nExclusion criteria for cases and controls:\n\n1. Non-Diabetic patients with AKI\n2. Diabetic patients with:\n\n * HBS Ag, HCV, HIV\n * Active Lupus\n * Active Malignancy\n * Acute or Chronic Liver Disease\n * Acute poisoning'}, 'identificationModule': {'nctId': 'NCT05147818', 'briefTitle': 'Risk Factors for Acute Kidney Injury in Diabetic Patients', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Risk Factors for Acute Kidney Injury in Diabetic Patients', 'orgStudyIdInfo': {'id': 'SSA'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cases', 'description': '200 Diabetic patients of 18 year and older (either type 1or 2) presented by AKI based on KIDIGO Definition \\& Staging. KDIGO definition of AKI: Increase in serum creatinine by ≥0.3 mg/dL (≥26.5 µmol/L) within 48 h, or Increase in serum creatinine to ≥1.5 times baseline that is known or presumed to have occurred within the prior 7 days, or Urine volume \\<0.5 mL/kg/h for 6 h.\n\nKDIGO staging of AKI: (1) stage 1: Serum creatinine 1.5-1.9 × baseline or ≥0.3 mg/dL (≥26.5 µmol/L) increase / Urine output \\<0.5 mL/kg/h for 6-12 h (2) stage 2; Serum creatinine 2.0-2.9 × baseline / Urine output \\<0.5 mL/kg/h for ≥12 h (3) stage 3: Serum creatinine 3.0 × baseline, increase in serum creatinine to ≥4.0 mg/dL (≥353.6 µmol/L), initiation of renal replacement therapy, or, in patients \\<18 years, decrease in eGFR to \\<35 mL/min per 1.73 m2 / Urine output \\<0.3 mL/kg/h for ≥24 h or anuria for ≥12 h .', 'interventionNames': ['Other: CBC ,renal function tests , fundus Examination']}, {'label': 'Controls', 'description': '200 Diabetic patients of 18 year and older with no AKI (either type 1or 2) Matched to controls in age ,sex'}], 'interventions': [{'name': 'CBC ,renal function tests , fundus Examination', 'type': 'OTHER', 'otherNames': ['ECG'], 'description': 'Laboratory investigations', 'armGroupLabels': ['Cases']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Shimaa Salah Ali', 'investigatorAffiliation': 'Assiut University'}}}}