- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03261518
Investigation of Relationship Between Contrast Nephropathy and Caval Index Measurement in Patients With Ileus in ED
August 23, 2017 updated by: Ali Yusuf Uyanik, Derince Training and Research Hospital
Investigation of Relationship Between Contrast Nephropathy and Caval Index Measurement in Patients With Suspected Ileus in Emergency Department
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
- enhanced CT for diagnostic purposes in ileus patients and to investigate the incidence and risk of developing contrast nephropathy due to contrast - enhanced CT.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Observational
Enrollment (Anticipated)
250
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: ALI Y UYANIK, RESIDENT
- Phone Number: +90 505 220 84 09
- Email: alifen_56@hotmail.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Community sample
Description
Inclusion Criteria:
- Patients who underwent contrast abdominal CT and were admitted to our general surgery department for at least 48 hours
- Written informed patients
- Patients older than 18 years
Exclusion Criteria:
- With contrast agent allergy
- Story of renal replacement therapy
- Contrast agent exposure within the last 10 days
- Pregnancy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Estimate contrast nephropathy in patients with low volume status by calculating Vena cava index
Time Frame: 48 hours
|
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.
|
48 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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. Erratum In: Ann Intern Med. 2008 Aug 5;149(3):219.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
August 24, 2017
Primary Completion (ANTICIPATED)
December 15, 2017
Study Completion (ANTICIPATED)
December 15, 2017
Study Registration Dates
First Submitted
August 23, 2017
First Submitted That Met QC Criteria
August 23, 2017
First Posted (ACTUAL)
August 25, 2017
Study Record Updates
Last Update Posted (ACTUAL)
August 25, 2017
Last Update Submitted That Met QC Criteria
August 23, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KÜ GOKAEK 2017/1.13
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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