Phase 4
N=122
Contrast Nephropathy and Nitrates
Contrast Induced Nephropathy
Bottom Line
View on ClinicalTrials.gov: NCT01999517 ↗Enrolled (actual)
122
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcome: Primary: Change in GFR — 1.8; -4.1 mL/min
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Intravenous Nitroglycerin (Drug); IV Fluids (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mt. Sinai Medical Center, Miami
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in GFR |
1.8; -4.1 | — |
Summary
Contrast-induced nephropathy (CIN) is a complication of percutaneous coronary angiography that occurs in about 10 to 20% of patients exposed to contrast media. Iodinated contrast is used during coronary angiography to see the coronary arteries. It has been shown that exposure to this agent may cause kidney injury. CIN usually goes away on its own but in some high risk patients it progresses into renal failure.
This research study offers a new possible option to prevent CIN. We propose that if intravenous nitroglycerin is given before the procedure it may lower the chances of developing contrast-induced nephropathy.
Eligibility Criteria
Inclusion Criteria
- Patient must be scheduled for percutaneous coronary angiography.
- Patients must have a Mehran score more or equal to 6 before the procedure.
- Patients must have baseline creatinine and hemoblogin drawn before the procedure.
- Signed informed consent.
Exclusion Criteria
- Patients on renal replacement therapy before randomization, will be excluded.
- Being exposed to any types of nitrates 48 hours prior to randomization,
- History of allergic reaction to any of the components of intravenous nitroglycerin.
- Exposure to contrast media 4 days prior randomization.
- Planned revascularization in the next 24 to 48 hours of the first PCI procedure.
- The patient is hypotensive (<90/60mmHg) at the time of randomization.
Data sourced from ClinicalTrials.gov (NCT01999517). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.