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NCT00900640 · ClinicalTrials.gov registry record
Reactions to Contrast Media (CM) Administered at the Time of the Endoscopic Retrograde Cholangiopancreatography (ERCP)
A clinical trial of Contrast Allergies, sponsored by University of Florida.
- Completed
- Registry status
- 27
- Enrollment target
- 1
- Study location
NCT00900640: Completed study of Contrast Allergies, sponsored by University of Florida.
NCT00900640 is a study of Contrast Allergies that has completed, run by University of Florida. The registered enrollment target is 27 participants. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00900640, a study of Contrast Allergies, has completed, sponsored by University of Florida.
- COMPLETED
- Registry status
- 27 participants
- Enrollment target
- 1
- Study location
Study Summary
The aim of this study is to prospectively document the incidence of CM adverse reactions at the time of ERCP and to determine whether various perceived risk factors are predictive of adverse reaction. Adverse reactions to iodine containing contrast media (CM) have been described after endoscopic retrograde cholangiopancreaticography (ERCP) but have been difficult to study due to their extremely low incidence. Adverse reactions can be classified by severity (mild, moderate or severe) or underlying mechanism (idiosyncratic versus nonidiosyncratic). Nonidiosyncratic reactions are related to the dose and osmolality of the CM; these are not observed during ERCP due to the relative small amount of systemic absorption of CM. Idiosyncratic reactions on the other hand are not dose-dependent and generally occur shortly after administration of CM. Premedication with corticosteroids, H1/H2 -blockers and the use of low osmolality CM is beneficial in preventing nonidiosyncratic reactions during intravascular administration. However their role in during ERCP is unclear as CM is not injected into the intravascular space. Currently there are no formal recommendations and clinical practice varies considerably. The general purpose of this study is to determine the incidence of CM reactions during ERCP and to determine whether various risk factors are predictive of idiosyncratic reactions. Based on these results, we hope to develop guidelines for the use of prophylaxis to prevent CM reactions in ERCP.
Conditions Studied
Interventions
- PROCEDURE ERCP as medically indicated by subjects referring physician
Study Locations (1)
Florida
- Shands UF endoscopy Center - Gainesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2009-05 |
| Est. Completion | 2017-03 |
What the finished NCT00900640 record still lists
NCT00900640 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 27 participants, a relatively small participant target.
The record links to 1 condition, with Contrast Allergies appearing as the primary indexed condition, and to 1 intervention - of which ERCP as medically indicated by subjects referring physician is the first listed.
NCT00900640 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT00900640 about?
NCT00900640 is a clinical study titled "Reactions to Contrast Media (CM) Administered at the Time of the Endoscopic Retrograde Cholangiopancreatography (ERCP)". The aim of this study is to prospectively document the incidence of CM adverse reactions at the time of ERCP and to determine whether various perceived risk factors are predictive of adverse reaction. Adverse reactions to iodine containing contrast media (CM) have been described after endoscopic re...
What is the current status of trial NCT00900640?
This trial is currently completed. The enrollment target is 27 participants. The study started on 2009-05. Estimated completion is 2017-03.
What conditions does trial NCT00900640 study?
This clinical trial studies the following conditions: Contrast Allergies.
What interventions are being tested in trial NCT00900640?
The interventions under investigation include: ERCP as medically indicated by subjects referring physician (PROCEDURE).
Who is sponsoring clinical trial NCT00900640?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00900640 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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