Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2026-01-07 @ 11:22 PM
Study NCT ID:
NCT03268460
Status:
UNKNOWN
Last Update Posted:
2017-09-01
First Post:
2017-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Incidence of Renal Tubular Acidosis in Nephrology Unit in Assiut University Childern Hospital
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000141', 'term': 'Acidosis, Renal Tubular'}], 'ancestors': [{'id': 'D015499', 'term': 'Renal Tubular Transport, Inborn Errors'}, {'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': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D000138', 'term': 'Acidosis'}, {'id': 'D000137', 'term': 'Acid-Base Imbalance'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001784', 'term': 'Blood Gas Analysis'}, {'id': 'D000136', 'term': 'Acid-Base Equilibrium'}, {'id': 'D007677', 'term': 'Kidney Function Tests'}, {'id': 'D016482', 'term': 'Urinalysis'}], 'ancestors': [{'id': 'D001774', 'term': 'Blood Chemical Analysis'}, {'id': 'D019963', 'term': 'Clinical Chemistry Tests'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D012129', 'term': 'Respiratory Function Tests'}, {'id': 'D003948', 'term': 'Diagnostic Techniques, Respiratory System'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D001669', 'term': 'Biochemical Phenomena'}, {'id': 'D055598', 'term': 'Chemical Phenomena'}, {'id': 'D006863', 'term': 'Hydrogen-Ion Concentration'}, {'id': 'D008660', 'term': 'Metabolism'}, {'id': 'D006706', 'term': 'Homeostasis'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D001790', 'term': 'Blood Physiological Phenomena'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}, {'id': 'D003950', 'term': 'Diagnostic Techniques, Urological'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2019-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-08-30', 'studyFirstSubmitDate': '2017-08-28', 'studyFirstSubmitQcDate': '2017-08-29', 'lastUpdatePostDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'percentage of cases with newly diagnosed renal tubular acidosis', 'timeFrame': 'Baseline', 'description': 'percentage of cases presented by metabolic acidosis , failure to thrive and polyuria and diagnosed as RTA by arterial blood gases, blood anion gap, serum electrolytes, kidney function tests and urine analysis.'}], 'secondaryOutcomes': [{'measure': 'percentage of cases with each type of RTA', 'timeFrame': 'Baseline', 'description': 'this is by measurement of serum K+ and urine PH. normal or low level of serum K+ with urine PH \\< 5,5 with proximal RTA, while normal or low level of serum K+ with urine PH \\> 5,5 with distal RTA. high level of serum K+ with urine PH \\< 5,5 with hyperkalemic type 4 RTA, while high level of serum K+ with urine PH \\> 5,5 with voltage defect distal RTA'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Renal Tubule Acidosis']}, 'descriptionModule': {'briefSummary': 'Providing summarized information on the clinical and biochemical characteristics and types of renal tubular acidosis in children in Assiut University Childern Hospital.', 'detailedDescription': 'The term renal tubular acidosis (RTA) is applied to a group of transport defects in the reabsorption of bicarbonate (HCO3\\_), the excretion of hydrogen ion (H\\_), or both. This condition was first described in 1935, confirmed as a renal tubular disorder in 1946, and designated "renal tubular acidosis" in 1951. The RTA syndromes are characterized by a relatively normal GFR and a metabolic acidosis accompanied by hyperchloremia and a normal plasma anion gap.\n\nRTA is classified into 4 major forms: distal, proximal, hyperkalemic and combined RTA. Distal RTA is associated with reduced urinary acid secretion, proximal RTA ( pRTA ) is characterized by impaired bicarbonate (HCO3\\_) reabsorption, hyperkalemic RTA is an acid-base disturbance generated by aldosterone deficiency or resistance and combined RTA is due to carbonic anhydrase II deficiency. Electrolyte and acid-base disturbances are key components of each disorder .\n\nPatients with pRTA present with growth failure in the 1st yr of life. Additional symptoms can include polyuria, dehydration (from sodium loss), anorexia, vomiting, constipation, and hypotonia. Patients with primary Fanconi syndrome have additional symptoms, secondary to phosphate wasting, such as rickets. Hypokalemia and related symptoms are also restricted to cases with the Fanconi syndrome.\n\nDistal RTA shares features with those of pRTA, including non-anion gap metabolic acidosis and growth failure; distinguishing features of distal RTA include nephrocalcinosis and hypercalciuria Combined proximal and distal RTA is a type observed as the result of inherited carbonic anhydrase II deficiency in different organs and systems.\n\nPatients with type IV RTA can present with growth failure in the first few years of life. Polyuria and dehydration (from salt wasting) are common. Laboratory tests reveal a hyperkalemic non-anion gap metabolic acidosis. Urine may be alkaline or acidic. Elevated urinary sodium levels with inappropriately low urinary potassium levels reflect the absence of aldosterone effect .\n\nThe first step in the evaluation of a patient with suspected RTA is to confirm the presence of a normal anion gap metabolic acidosis, identify electrolyte abnormalities, assess renal function, and rule out other causes of bicarbonate loss such as diarrhea .\n\nThe mainstay of therapy in all forms of RTA is bicarbonate replacement. Patients with pRTA often require large quantities of bicarbonate, up to 20 mEq/kg/24 hr. The base requirement for distal RTAs is generally in the range of 2-4 mEq/kg/24 hr, although patients\' requirements can vary. Patients with type IV RTA can require chronic treatment for hyperkalemia with sodium potassium exchange resin .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Year', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '• All cases presented with hypokalemia and normal anion gap hyperchloremic metabolic acidosis with a relatively normal glomerular filteration rate.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age : From 1 year to 18 year.\n* Sex : Both sex male and female.\n* All cases presented with hypokalemia and normal anion gap hyperchloremic metabolic acidosis with a relatively normal glomerular filteration rate.\n\nExclusion Criteria:\n\n* Acute diarrhea .\n* Urinary diversions.\n* Post hypocapnia.\n* Postobstructive diuresis.\n* Interstitial nephritis.\n* Active urinary tract infection.\n* Intake of medications interfere with urinary acidification.'}, 'identificationModule': {'nctId': 'NCT03268460', 'briefTitle': 'Incidence of Renal Tubular Acidosis in Nephrology Unit in Assiut University Childern Hospital', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Incidence of Renal Tubular Acidosis in Nephrology Unit in Assiut University Childern Hospital (AUCH)', 'orgStudyIdInfo': {'id': 'RTA in childern'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Arterial blood gases', 'type': 'DIAGNOSTIC_TEST', 'description': 'blood PH, HCO3'}, {'name': 'Blood anion gap', 'type': 'DIAGNOSTIC_TEST', 'description': '(Na+) - (Cl- + HCO3-)'}, {'name': 'serum electrolytes', 'type': 'DIAGNOSTIC_TEST', 'description': 'Na+ , K+ , Cl- and calcium'}, {'name': 'renal function test', 'type': 'DIAGNOSTIC_TEST', 'description': 'blood urea and serum creatinine'}, {'name': 'urine analysis', 'type': 'DIAGNOSTIC_TEST', 'description': 'urine PH, specific gravity, aminoaciduria, glycosuria, phospaturia and 24 hr urine calcium'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Sally Ezzat', 'role': 'CONTACT', 'email': 'sallyezzat1992@gmail.com', 'phone': '01001349860', 'phoneExt': '00+20'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Sally Ezzat Shafik mikhail', 'investigatorAffiliation': 'Assiut University'}}}}