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Effects of withdrawing vs continuing metformin on contrast-induced nephropathy in diabetes mellitus with renal insufficiency after percutaneous coronary intervention: A prospective, randomized, noninferiority clinical study

Effects of withdrawing vs continuing metformin on contrast-induced nephropathy in diabetes mellitus with renal insufficiency after percutaneous coronary intervention: A prospective, randomized, noninferiority clinical study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-17012271
Enrollment
Unknown
Registered
2017-08-06
Start date
2017-09-01
Completion date
Unknown
Last updated
2017-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

contrast induced nephropathy

Interventions

continue metformin:Follow the original metformin dose and continue to use it for third days after operation
withdraw metformin:withdraw metformin group, the metformin was held at least 24 hours before the procedure and up to 72 hours after the procedure

Sponsors

Department of Cardiology, Zhongda Hospital of Southeast University Medical School
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) volunteered to participate in this trial and signed informed consent; (2) Aged 18 to 80 Years; (3) Planned percutaneous coronary intervention(PCI); (4) CKD stages 1,2, eGFR 30 to 89ml/min per 1.73m2; (5) T2DM; (6) received any metformin at least 14 days.

Exclusion criteria

Exclusion criteria: (1) a history of lactic acidosis; (2) Hypersensitivity to iodine-containing compounds; (3)eGFR=90ml/min per 1.73m2 or eGFR<30ml/min per 1.73m2); (4) acute ST-segment elevation myocardial infarction (STEMI); (5) NYHA class IV or hemodynamic instability; Administration of ACEI/ARB within 14 days before randomization; (6) Take CT, MRI and other examinations with contrast agents during the two weeks before study; take radiographic examination of other contrast agents during the study period; (7) blood pressure <120/80mmHg; (8) Hepatic dysfunction (ALT 3 times greater than upper normal limit); (9) Thyreoid insufficiency; (10) Malignant tumors, inflammatory diseases, autoimmune diseases.

Design outcomes

Primary

MeasureTime frame
Primary Outcome Measures:The incedence of CIN;—

Secondary

MeasureTime frame
Secondary Outcome Measures: The composite of hospitalization for aggravated renal function, acute renal failure, dialysis or hemofiltration, aggravated at least 1 class of heart function, acute left ventricular failure or death from all causes occurring within 30 days after contrast.;—

Contacts

Public ContactChengchun Tang

Department of Cardiology, Zhongda Hospital of Southeast University Medical School

tangchengchun@medmail.com.cn+86 13914705570

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026