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NCT00209417 · ClinicalTrials.gov registry record · Phase 4
Renal Effects of Two Iodinated Contrast Media in Patients at Risk Undergoing Computed Tomography
A Phase 4 study, sponsored by GE Healthcare.
- Terminated
- Registry status
- Phase 4
- Development phase
- 656
- Enrollment target
NCT00209417 is a Phase 4 study that was terminated before completion, run by GE Healthcare. The registered enrollment target is 656 participants.
The verdict
NCT00209417, a Phase 4 study, was terminated before completion, sponsored by GE Healthcare.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 656 participants
- Enrollment target
Study Summary
It is well known that X-ray contrast media can affect kidney function in some patients, especially when administered intra-arterially, and patients who already suffer from reduced kidney function and diabetes mellitus may be at increased risk. It is widely accepted to use low-osmolar or iso-osmolar contrast media, especially in patients at risk for contrast media-induced nephropathy. However, little is known about the intravenous use of X-ray contrast media in risk patients, such as contrast-enhanced CT examinations. The main purpose of this study is to evaluate and compare the effects on kidney function of two contrast media, the iso-osmolar iodixanol and the low-osmolar iopamidol in patients at risk of kidney damage associated with the injection of contrast media. Due to the iso-osmolar feature, it is expected less influence on renal function following administration of iodixanol. A standard hydration procedure, based on available guidelines will be given to all patients to prevent negative effects on the kidneys. Serum creatinine (SCr ) concentrations will be measured before and up to 7 days after contrast media administration to evaluate the effects on renal function.
Interventions
- DRUG Iodixanol 320-Arm 1
- DRUG Iopamidol 300-Arm 2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 656 participants |
| Start Date | 2005-06 |
| Est. Completion | 2011-07 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00209417
The ClinicalTrials.gov registry entry for NCT00209417 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 656 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GE Healthcare, which has 99 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Iodixanol 320-Arm 1 is the first listed.
NCT00209417 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00209417 about?
NCT00209417 is a clinical study titled "Renal Effects of Two Iodinated Contrast Media in Patients at Risk Undergoing Computed Tomography". It is well known that X-ray contrast media can affect kidney function in some patients, especially when administered intra-arterially, and patients who already suffer from reduced kidney function and diabetes mellitus may be at increased risk. It is widely accepted to use low-osmolar or iso-osmolar ...
What is the current status of trial NCT00209417?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 656 participants. The study started on 2005-06. Estimated completion is 2011-07.
What interventions are being tested in trial NCT00209417?
The interventions under investigation include: Iodixanol 320-Arm 1 (DRUG), Iopamidol 300-Arm 2 (DRUG).
Who is sponsoring clinical trial NCT00209417?
This trial is sponsored by GE Healthcare, which has 99 total clinical trials registered on ClinicalTrials.gov.
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