Ignite Creation Date:
2025-12-24 @ 12:24 PM
Ignite Modification Date:
2026-01-09 @ 12:52 AM
Study NCT ID:
NCT03369561
Status:
UNKNOWN
Last Update Posted:
2017-12-12
First Post:
2017-11-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Between Right and Left Ventricular Systolic Dysfunction as a Risk Factors for Aki in Critical Care Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058186', 'term': 'Acute Kidney Injury'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2020-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-12-10', 'studyFirstSubmitDate': '2017-11-25', 'studyFirstSubmitQcDate': '2017-12-10', 'lastUpdatePostDateStruct': {'date': '2017-12-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AKI during the 1st 7 days of ICU care,', 'timeFrame': 'One year', 'description': 'defined by an increase of ≥ 0.3 mg/dl in serum creatinine within 48 hours of ICU admission, an increase of ≥ 50% within 7 days of ICU admission, or acute dialysis, in keeping with the Kidney Disease Improving Global Outcomes guidelines.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Acute Kidney Injury (Nontraumatic)']}, 'referencesModule': {'references': [{'pmid': '24810531', 'type': 'BACKGROUND', 'citation': 'Legrand M, Mebazaa A, Ronco C, Januzzi JL Jr. When cardiac failure, kidney dysfunction, and kidney injury intersect in acute conditions: the case of cardiorenal syndrome. Crit Care Med. 2014 Sep;42(9):2109-17. doi: 10.1097/CCM.0000000000000404.'}, {'pmid': '18158481', 'type': 'BACKGROUND', 'citation': 'Liang KV, Williams AW, Greene EL, Redfield MM. Acute decompensated heart failure and the cardiorenal syndrome. Crit Care Med. 2008 Jan;36(1 Suppl):S75-88. doi: 10.1097/01.CCM.0000296270.41256.5C.'}, {'pmid': '23254894', 'type': 'BACKGROUND', 'citation': 'F Gnanaraj J, von Haehling S, Anker SD, Raj DS, Radhakrishnan J. The relevance of congestion in the cardio-renal syndrome. Kidney Int. 2013 Mar;83(3):384-91. doi: 10.1038/ki.2012.406. Epub 2012 Dec 19.'}, {'pmid': '23499048', 'type': 'BACKGROUND', 'citation': 'Palevsky PM, Liu KD, Brophy PD, Chawla LS, Parikh CR, Thakar CV, Tolwani AJ, Waikar SS, Weisbord SD. KDOQI US commentary on the 2012 KDIGO clinical practice guideline for acute kidney injury. Am J Kidney Dis. 2013 May;61(5):649-72. doi: 10.1053/j.ajkd.2013.02.349. Epub 2013 Mar 15.'}, {'pmid': '19433995', 'type': 'BACKGROUND', 'citation': 'van Walraven C, Austin PC, Jennings A, Quan H, Forster AJ. A modification of the Elixhauser comorbidity measures into a point system for hospital death using administrative data. Med Care. 2009 Jun;47(6):626-33. doi: 10.1097/MLR.0b013e31819432e5.'}, {'pmid': '25690125', 'type': 'BACKGROUND', 'citation': 'Gutacker N, Bloor K, Cookson R. Comparing the performance of the Charlson/Deyo and Elixhauser comorbidity measures across five European countries and three conditions. Eur J Public Health. 2015 Feb;25 Suppl 1:15-20. doi: 10.1093/eurpub/cku221.'}]}, 'descriptionModule': {'briefSummary': 'The cardio renal syndrome generally focuses on left ventricular function, and the importance of the right ventricle as a determinant of renal function is described less frequently. Although the risk of AKI is similar for patients with isolated LVD and isolated RVD, the severity of AKI and the associated risk of hospital mortality is highest among those with isolated RVD.', 'detailedDescription': 'The right ventricle seems to affect renal function through different mechanisms, including Venous Congestion, tricuspid regurgitation, And potential inhibitory effect on left ventricular function The most important mechanism is venous congestion, a manifestation of sodium avidity and fluid expansion, as Directly increasing renal venous pressure causes sodium retention, lowers urinary output, and decreases glomerular filtration and widely thought to explain AKI Venous pressure is directly associated with renal dysfunction, independently of ventricular function, and admission peripheral edema is associated with greater risk of AKI. Such awareness of a primary role of renal venous congestion reshapes our understanding of renal function as not simply a reflection of arterial perfusion, but rather a balance between arterial supply and venous drainage.\n\n.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All pt admitted to ICU with Lt , Rt or Bi ventricular dysfunction That develops AKI', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* cardiac patient\n\nExclusion Criteria:\n\n* ESRD pt CKD Cirrhotic patients AKI due to post renal cause'}, 'identificationModule': {'nctId': 'NCT03369561', 'briefTitle': 'Comparison Between Right and Left Ventricular Systolic Dysfunction as a Risk Factors for Aki in Critical Care Patients', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Comparison Between Right and Left Ventricular Systolic Dysfunction as a Risk Factors for AKI in Critical Care Patients', 'orgStudyIdInfo': {'id': 'CBRALVSDASRFFAKICCP'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'normal cardiac patient', 'description': 'Full history and clinical examination ECG on the left and right side Echocardiography and measurement of both left and right ventricular functions Laboratory investigation including cardiac enzymes, CK, CK MB, and cardiac troponin I.\n\nSerum urea and creatinine and the calculated e GFR', 'interventionNames': ['Diagnostic Test: Serum urea and creatinine and the calculated e GFR']}], 'interventions': [{'name': 'Serum urea and creatinine and the calculated e GFR', 'type': 'DIAGNOSTIC_TEST', 'description': 'The primary outcome will be AKI during the 1st 7 days of ICU care, as defined by an increase of ≥ 0.3 mg/dl in serum creatinine within 48 hours of ICU admission, an increase of ≥ 50% within 7 days of ICU admission, or acute dialysis', 'armGroupLabels': ['normal cardiac patient']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'Assiut University71515', 'city': 'Asyut', 'country': 'Egypt', 'facility': 'Assiut University Hospital', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'Ahmed A Obiedallah, lecture', 'role': 'CONTACT', 'email': 'ahmed_obiedallah@yahoo.com', 'phone': '00201007556396'}, {'name': 'Noura G Nasr, RD', 'role': 'CONTACT', 'email': 'noura.victory@gmail.com', 'phone': '00201096137766'}], 'overallOfficials': [{'name': 'Ashraf M El-Shazly, Prof', 'role': 'STUDY_CHAIR', 'affiliation': 'Assiut'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principle Investigator', 'investigatorFullName': 'Noura gamal', 'investigatorAffiliation': 'Assiut University'}}}}