Ignite Creation Date:
2025-12-25 @ 4:35 AM
Ignite Modification Date:
2025-12-26 @ 3:37 AM
Study NCT ID:
NCT03261518
Status:
UNKNOWN
Last Update Posted:
2017-08-25
First Post:
2017-08-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Investigation of Relationship Between Contrast Nephropathy and Caval Index Measurement in Patients With Ileus in ED
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D045823', 'term': 'Ileus'}], 'ancestors': [{'id': 'D007415', 'term': 'Intestinal Obstruction'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-08-24', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2017-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-08-23', 'studyFirstSubmitDate': '2017-08-23', 'studyFirstSubmitQcDate': '2017-08-23', 'lastUpdatePostDateStruct': {'date': '2017-08-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Estimate contrast nephropathy in patients with low volume status by calculating Vena cava index', 'timeFrame': '48 hours', 'description': 'Estimate contrast nephropathy in patients with low volume status by calculating Vena cava index In this study, we aimed to evaluate the incidence of vena cava inferior vena cava on ultrasound guidance of intravascular volume before diagnosis of contrast-enhanced CT and to investigate the incidence and development of contrast nephropathy due to contrast-enhanced CT.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ileus', 'Contrast-induced Nephropathy', 'vena cava inferior'], 'conditions': ['Ileus; Mechanical', 'Contrast-induced Nephropathy']}, 'referencesModule': {'references': [{'pmid': '15939688', 'type': 'BACKGROUND', 'citation': 'Habeb M, Agac MT, Aliyev F, Pehlivanoglu S, Ongen Z. [Contrast media-induced nephropathy: clinical burden and current attempts for prevention]. Anadolu Kardiyol Derg. 2005 Jun;5(2):124-9. Turkish.'}, {'pmid': '27659469', 'type': 'BACKGROUND', 'citation': 'McCullough PA, Choi JP, Feghali GA, Schussler JM, Stoler RM, Vallabahn RC, Mehta A. Contrast-Induced Acute Kidney Injury. J Am Coll Cardiol. 2016 Sep 27;68(13):1465-1473. doi: 10.1016/j.jacc.2016.05.099.'}, {'pmid': '16263365', 'type': 'BACKGROUND', 'citation': 'Sanaei-Ardekani M, Movahed MR, Movafagh S, Ghahramani N. Contrast-induced nephropathy: a review. Cardiovasc Revasc Med. 2005 Apr-Jun;6(2):82-8. doi: 10.1016/j.carrev.2005.07.004.'}, {'pmid': '18283206', 'type': 'BACKGROUND', 'citation': 'Kelly AM, Dwamena B, Cronin P, Bernstein SJ, Carlos RC. Meta-analysis: effectiveness of drugs for preventing contrast-induced nephropathy. Ann Intern Med. 2008 Feb 19;148(4):284-94. doi: 10.7326/0003-4819-148-4-200802190-00007.'}]}, 'descriptionModule': {'briefSummary': 'In this study, the investigators aimed to evaluate the incidence of vena cava inferior diamater on ultrasound guidance of intravascular volume before diagnosis of contrast\n\n\\- enhanced CT for diagnostic purposes in ileus patients and to investigate the incidence and risk of developing contrast nephropathy due to contrast - enhanced CT.', 'detailedDescription': "Our work will be carried out in Kocaeli Derince Education and Research Hospital Emergency Service. Patients who are scheduled to receive abdominal contrast computed tomography (CT) scans in the emergency room, who are over 18 years of age, who are referred to Kocaeli Derince Education and Research Hospital Emergency Department for the study, will be calculated and recorded. The Mehran risk scores will be calculated and recorded in our clinic. 3 ml / kg IV physiological saline (SF) is applied first and then 1 ml / kg / hr IV SF is applied for at least 6 hours after shots. In addition, patients with contrasted abdominal CT underwent emergency surveillance ultrasound imaging (including the measurement of the vena cava diameter for evaluation of the patient's volume status). Patients who were admitted to our general surgery and not followed up for at least 48 hours, patients with contrast allergies, patients with renal replacement therapy, pregnancies, patients with contrast-enhanced CT scans within the last 10 days, and patients not informed will not be taken to the study. All Emergency Physicians will be informed about the study. Less than 100 mL of hypoosmolar, non-ionic contrast material will be used for all CT shots. Patients will be evaluated for the development of contrast nephropathy according to biochemical assays 48-72 hours after CT acquisition. Physicians evaluating patients in the emergency and general surgery services will be required to record blood tests that they consider necessary for diagnostic and therapeutic purposes, and no extra blood will be collected for use in the study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Community sample', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who underwent contrast abdominal CT and were admitted to our general surgery department for at least 48 hours\n* Written informed patients\n* Patients older than 18 years\n\nExclusion Criteria:\n\n* With contrast agent allergy\n* Story of renal replacement therapy\n* Contrast agent exposure within the last 10 days\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT03261518', 'briefTitle': 'Investigation of Relationship Between Contrast Nephropathy and Caval Index Measurement in Patients With Ileus in ED', 'organization': {'class': 'OTHER', 'fullName': 'Derince Training and Research Hospital'}, 'officialTitle': 'Investigation of Relationship Between Contrast Nephropathy and Caval Index Measurement in Patients With Suspected Ileus in Emergency Department', 'orgStudyIdInfo': {'id': 'KÜ GOKAEK 2017/1.13'}}, 'armsInterventionsModule': {'interventions': [{'name': 'inferior vena cava ultrasound', 'type': 'PROCEDURE', 'description': 'Place the patient in the supine position. The degree of elevation of the head of the bed has not been shown to make a significant difference in measurements. The diameter of the IVC for calculation of the caval index should be measured 2 cm from where it enters the right atrium .An alternative way to visualize respiratory variation is to use M-mode, with the beam overlying the IVC 2 cm from the right atrium.The inspiratory and expiratory diameter can then be measured on the M-mode image, at the smallest and largest locations, respectively.'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'ALI Y UYANIK, RESIDENT', 'role': 'CONTACT', 'email': 'alifen_56@hotmail.com', 'phone': '+90 505 220 84 09'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Derince Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'EMERGENCY MEDICINE RESIDENT', 'investigatorFullName': 'Ali Yusuf Uyanik', 'investigatorAffiliation': 'Derince Training and Research Hospital'}}}}