Ileus; MechanicalNCT03261518
Investigation of Relationship Between Contrast Nephropathy and Caval Index Measurement in Patients With Ileus in ED
An observational study of Ileus; Mechanical and Contrast-induced Nephropathy, run by Derince Training and Research Hospital.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ileus; Mechanical, Contrast-induced Nephropathy
- What is being tested?
- inferior vena cava ultrasound
- Type of treatment
- Surgery or procedure
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- 24 Aug 2017to 15 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Community sample
Who may be able to join
- 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
Who cannot join
- With contrast agent allergy
- Story of renal replacement therapy
- Contrast agent exposure within the last 10 days
- Pregnancy
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Ileus; Mechanical, Contrast-induced Nephropathy
- Being tested
- inferior vena cava ultrasound
- Keywords
- ileus, Contrast-induced Nephropathy, vena cava inferior
- Medical subject headings
- Ileus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inferior vena cava ultrasoundProcedure or surgery
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimate contrast nephropathy in patients with low volume status by calculating Vena cava index
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.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2017
- Study start24 Aug 2017 (estimated)
- Primary completion15 Dec 2017 (estimated)
- Study completion15 Dec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Ileus; MechanicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Derince Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Yusuf Uyanik, Derince Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03261518
- Sponsor's protocol ID
- KÜ GOKAEK 2017/1.13
- Status last verified
- Aug 2017
- First submitted
- 23 Aug 2017
- Last updated
- 25 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 15939688McCullough 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.
PubMed 27659469Sanaei-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.
PubMed 16263365Kelly 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.
PubMed 18283206
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Relationship Between Contrast Nephropathy and Caval Index Measurement in Patients With Suspected Ileus in Emergency Department
- ClinicalTrials.gov ID
- NCT03261518
- Acronym / sponsor ID
- KÜ GOKAEK 2017/1.13
- Conditions
- Ileus; Mechanical, Contrast-induced Nephropathy
- Keywords
- ileus, Contrast-induced Nephropathy, vena cava inferior
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Derince Training and Research HospitalUniversity, hospital or other
- Study start
- 24 Aug 2017 (estimated)
- Primary completion
- 15 Dec 2017 (estimated)
- Study completion
- 15 Dec 2017 (estimated)
- First posted
- 25 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Community sample
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- With contrast agent allergy
- Story of renal replacement therapy
- Contrast agent exposure within the last 10 days
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| inferior vena cava ultrasoundPlace 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. | Procedure or surgery | – |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2017.
- Background: PubMed 15939688Habeb 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.
- Background: PubMed 27659469McCullough 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.
- Background: PubMed 16263365Sanaei-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.
- Background: PubMed 18283206Kelly 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Ileus; Mechanical and Contrast-induced Nephropathy, run by Derince Training and Research Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ALI Y UYANIK, RESIDENT (+90 505 220 84 09, alifen_56@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimate contrast nephropathy in patients with low volume status by calculating Vena cava index (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03261518, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2017.