N/A
Completed N=166
Safety of Continuing Metformin in Diabetic Patients With Normal Kidney Function Receiving Contrast Media
Diabetes · Lactic Acidosis
Source: ClinicalTrials.gov NCT01873859 ↗
Enrolled (actual)
166
Serious AEs
0.0%
Results posted
Jun 2014
Primary outcomePrimary: Incidence of Lactic Acidosis — 0; 0 participants
Summary
The purpose of this study is to determine whether metformin causes lactic acidosis in diabetic patients with preserved kidney function, undergoing coronary angiography or angioplasty with new contrast media.
In other words is it necessary to discontinue metformin before these procedures, even when Iodixanol is used as contrast media, which is isosmolar agent and much more safer than urografin which was the main agent in the previous studies that were the base of present guidelines?
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Lactic Acidosis |
0; 0 | — |
| PRIMARY Change of Baseline Creatinine 48 hr After Recieving Contrast Media in the Presence or Absence of Metformin Use. |
1.05; 0.99 | — |
Eligibility Criteria
Inclusion Criteria
- Diabetic patients receiving metformin who were scheduled for:
- coronary angiography
- coronary angioplasty
Exclusion Criteria
- Patients who had contraindication for metformin administration, such as:
- decompensated heart failure
- severe liver disease
- severe hypoxemia
- GFR<60 mL/min per 1.73 m2
Data sourced from ClinicalTrials.gov (NCT01873859). 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. Informational only — not medical advice.