Clinical Trial: Safety of Continuing Metformin in Diabetic Patients With Normal Kidney Function Receiving Contrast Media
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Incidence of Lactic Acidosis After Coronary Angiography and Angioplasty in Diabetic Patients on Continued Metformin Therapy With Normal Renal Function.
Brief 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?
Detailed Summary:
Although metformin is not directly nephrotoxic, it has been postulated that can impair gluconeogenesis from lactate, which may lead to lactate accumulation under circumstances such as acute renal failure. In diabetic patients receiving metformin, this condition can be encountered in the setting of acute renal failure following contrast media administration, during coronary angiography i.e. contrast-induced nephropathy. As a result, it has been a part of routine clinical practice to discontinue metformin before angiography to prevent metformin-associated lactic acidosis (MALA). However, there is no general consensus regarding the incidence of MALA and evidence for such intervention is poor. On the other hand, discontinuation of metformin can be associated with detrimental effects on glycemic control and thereby may increase cardiovascular risk in diabetic patients undergoing percutaneous coronary interventions. Consequently, questions have been raised recently regarding the routine discontinuation of metformin, in low-risk patients undergoing coronary angiography.
The present study was designed to assess the role of metformin in lactate production in a group of diabetic patients with normal renal function; and to address the questions about significance of routine discontinuation of metformin in low risk patients undergoing coronary angiography.
Iodixanol will be the only contrast media in all patients, because of its low nephrotoxicity. Serum blood urea nitrogen and creatinin; as well as arterial blood gases will be evaluated prior to angiography, and repeated 24 and 48 hours after the procedure. Glomerular filtration rate (GFR) is calculated using Cockcroft-Gault formula {GFR= 0.85 (for women)}.
Contrast-induced acute kidney injury is defined as a 25-50% or 0.3-0.5 mg/dl n
Sponsor: Shahid Beheshti University of Medical Sciences
Current Primary Outcome:
- Incidence of Lactic Acidosis [ Time Frame: 48 hrs ]Metformin-associated lactic acidosis (MALA) was defined as an arterial pH <7.35 and plasma lactate concentration >5 mmol ⁄ L.
- Change of Baseline Creatinine 48 hr After Recieving Contrast Media in the Presence or Absence of Metformin Use. [ Time Frame: 48 hours from the baseline ]
Original Primary Outcome: Incidence of Lactic Acidosis [ Time Frame: 48 hrs ]
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Shahid Beheshti University of Medical Sciences
Dates:
Date Received: June 5, 2013
Date Started: May 2013
Date Completion:
Last Updated: May 16, 2014
Last Verified: May 2014
