Safety of Continuing Metformin in Diabetic Patients With Normal Kidney Function Receiving Contrast Media

NCT ID: NCT01873859

Last Updated: 2014-06-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 166 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2014-02-28

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 Description

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 net increase in creatinine concentration compared to the baseline values. Metformin-associated lactic acidosis (MALA) is defined as an arterial pH (potential of hydrogen)<7.35 and plasma lactate concentration >5 mmol⁄L. In the M (-) group metformin will re-started 48 hours after angiography, albeit in the absence of evidence of lactic acidosis and GFR of >60 mL/min per 1.73 m2.

A written informed consent is taken from all participants and institutional review board has already approved the trial.

Conditions

Diabetes Mellitus; Lactic Acidosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

On-metformin

Diabetic patients receiving contrast media without discontinuing metformin.

Group Type: ACTIVE_COMPARATOR

Metformin

Intervention Type: DRUG

Incidence of lactic acidosis in diabetic patients receiving contrast media in the presence of metformin.

Off-metformin

Diabetic patients receiving contrast media with discontinuation of metformin.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Metformin

Incidence of lactic acidosis in diabetic patients receiving contrast media in the presence of metformin.

Intervention Type: DRUG

Other Intervention Names

Glucophage

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shahid Beheshti University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Saeed Alipour Parsa

Alipour Parsa S., Assistant professor of cardiology, Cardiovascular Research Center, Modarres hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Saeed Alipour Parsa

Role: PRINCIPAL_INVESTIGATOR

Cardiovascular research center, Modarres hospital, Shahid Beheshti University of Medical Sciences

Locations

Cardiovascular research center, Modarres hospital.

Tehran, Tehran Province, Iran

Countries

Iran

References

Goergen SK, Rumbold G, Compton G, Harris C. Systematic review of current guidelines, and their evidence base, on risk of lactic acidosis after administration of contrast medium for patients receiving metformin. Radiology. 2010 Jan;254(1):261-9. doi: 10.1148/radiol.09090690.

Reference Type: BACKGROUND

PMID: 20032157 (View on PubMed)

Other Identifiers

sbcvrc-43-891128

Identifier Type: -

Identifier Source: org_study_id