Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-27 @ 11:36 PM
Study NCT ID:
NCT04539834
Status:
COMPLETED
Last Update Posted:
2021-11-23
First Post:
2020-09-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Electrolyte State in Patients With COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004573', 'term': 'Electrolytes'}], 'ancestors': [{'id': 'D007287', 'term': 'Inorganic Chemicals'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 983}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2021-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-20', 'studyFirstSubmitDate': '2020-09-01', 'studyFirstSubmitQcDate': '2020-09-03', 'lastUpdatePostDateStruct': {'date': '2021-11-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'electrolytes disturbances in patients with COVID-19', 'timeFrame': '4 months', 'description': 'Serum Electrolytes (Na, K, Ca, Cl, Ph, Mg) abnormality in COVID 19 patients laboratory results in the different stages of the disease'}], 'secondaryOutcomes': [{'measure': 'To asses the relation of the electrolyte disturbances with the severity of COVID-19 infection.', 'timeFrame': '4 months', 'description': 'To find any correlation between the level of the electrolyte disturbances and the morbidity and mortality of the disease .'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Electrolytes; COVID-19'], 'conditions': ['Electrolyte Imbalance']}, 'descriptionModule': {'briefSummary': "Initial case reports and cohort studies have described many clinical characteristics of patients with coronavirus disease 2019 (COVID-19), an emerging infectious disorder caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). In early COVID-19 studies, some evidence has been provided that electrolyte disorders may also be present upon patients' presentation, including sodium, potassium, chloride and calcium abnormalities\n\nthe aim of the study is Identification of elements that affect COVID-19 pathology to improve survival and decrease mortality rate.", 'detailedDescription': 'SARS-CoV-2 invades human cells through binding angiotensin I converting enzyme 2 (ACE2) on the cell membrane. ACE2 is widely distributed in many types of human tissues, especially in the vital organs, such as heart, liver, kidney, and lungs. ACE2 is viewed as the principal counter-regulatory mechanism for the main axis of renin-angiotensin system (RAS) that is an essential player in the control of blood pressure and electrolyte balance. The final effect is to increase reabsorption of sodium and water, and thereafter increase blood pressure and excretion of potassium (K+). Besides, patients with COVID-19 often had gastrointestinal symptoms such as diarrhea and vomiting\n\nEarly studies proved that high percentage of COVID-19 patient were presented with electrolyte disorders, including sodium, potassium, chloride and calcium abnormalities. Such electrolyte disturbances have important implications not only for patient management but also for identifying potential pathophysiologic mechanisms underlying COVID-19 that could drive novel therapeutic opportunities'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients ≥ 18 years old with diagnosis of COVID-19 infection who admitted to Isolation hospital of Zagazig University Hospitals during the period from 1 May 2020 to 1 August 2020.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients ≥ 18 years old who were confirmed by the real-time PCR on the respiratory tract samples as positive of SARS-CoV-2.\n\nExclusion Criteria:\n\n* Patients who had other causes of electrolyte disturbances (9):\n* Chronic organ dysfunction (e.g., hepatic or renal dysfunction),\n* Terminal cancer, immunodeficiency, and\n* Patients with a history of long-term use of hormones \\& Diuretics were excluded.'}, 'identificationModule': {'nctId': 'NCT04539834', 'briefTitle': 'Electrolyte State in Patients With COVID-19', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Zagazig University'}, 'officialTitle': 'Electrolyte State in Patients With COVID-19', 'orgStudyIdInfo': {'id': '(ZU-IRB#: 6328-23-8-2020)'}}, 'armsInterventionsModule': {'interventions': [{'name': 'electrolytes', 'type': 'OTHER', 'description': 'measuring level of electrolytes'}]}, 'contactsLocationsModule': {'locations': [{'zip': '055', 'city': 'Zagazig', 'country': 'Egypt', 'facility': 'Zagazig University', 'geoPoint': {'lat': 30.58768, 'lon': 31.502}}], 'overallOfficials': [{'name': 'Tarek Hamdy, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'lecturer of Chest diseases, Faculty of Medicine, Zagazig University'}, {'name': 'Hadeer El Shahaat, master degree', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistant lecturer of Chest diseases, Faculty of Medicine, Zagazig University'}, {'name': 'Ahmed Abdulsaboor, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinical Pathology Department, Faculty of Medicine, Zagazig University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zagazig University', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer', 'investigatorFullName': 'Essamedin Mamdouh Negm', 'investigatorAffiliation': 'Zagazig University'}}}}