ClinicalTrials.gg
Status unknownNCT03261518Updated Aug 25, 2017

Investigation of Relationship Between Contrast Nephropathy and Caval Index Measurement in Patients With Ileus in ED

An observational study in Ileus; Mechanical and Contrast-induced Nephropathy, sponsored by Derince Training and Research Hospital. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-08-25.

Sponsored by Derince Training and Research Hospital · Observational

The sponsor has not verified this record recently (last verified Aug 2017), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
250
Ages
18 Years and older
Sex
All
01

Study 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 - 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.

02

Conditions studied

  • Ileus; Mechanical
  • Contrast-induced Nephropathy

Browse trials for

Keywords

  • ileus
  • Contrast-induced Nephropathy
  • vena cava inferior
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In context

Ileus

167 studies on the registry are indexed under Ileus; 23 are open to participants now.

This study's planned enrollment of 250 is above the median of 159 across 26 observational studies indexed under Ileus.

Browse Ileus studies →

Lead sponsor

Derince Training and Research Hospital is the lead sponsor of 39 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Community sample

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • With contrast agent allergy
  • Story of renal replacement therapy
  • Contrast agent exposure within the last 10 days
  • Pregnancy
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
250 participants (estimated)
Patient registry
No

Interventions

  • Procedureinferior vena cava ultrasound

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 48 hours

07

Study locations

No study locations are listed for this record.

08

References and documents

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 15939688 ↗
  • 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. PubMed 27659469 ↗
  • 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. PubMed 16263365 ↗
  • 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. PubMed 18283206 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Aug 2017; primary completion for Dec 2017, 3 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 23, 2017
First posted
Aug 25, 2017
StartEst.
Aug 24, 2017
Primary completionEst.
Dec 15, 2017
CompletionEst.
Dec 15, 2017
Last update
Aug 25, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 25, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03261518
Lead sponsor
Derince Training and Research Hospital
Responsible party
Ali Yusuf Uyanik (EMERGENCY MEDICINE RESIDENT, Derince Training and Research Hospital) — Principal investigator
First posted
Aug 25, 2017
Start date
Aug 24, 2017 (estimated)
Primary completion
Dec 15, 2017 (estimated)
Completion
Dec 15, 2017 (estimated)
Last update
Aug 25, 2017

Study contacts

ALI Y UYANIK, RESIDENT
Contact
alifen_56@hotmail.com
+90 505 220 84 09

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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