Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of this prospective, randomized, controlled study is to investigate the effect of pretreatment with intravenous Alprostadil on the incidence of CIN in a high-risk population of patients with both type 2 diabetes mellitus (T2DM) and CKD undergoing coronary angiography, and evaluate the influence of such potential benefit on short-term outcome.
The number of cardiac angiography and percutaneous coronary interventions (PCI) has increased steadily in recent years. This has resulted in the increasing incidence of contrast-induced nephropathy (CIN). Major risk factors for CIN include older age, diabetes mellitus (DM), chronic kidney disease (CKD).
The aim of this prospective, randomized, controlled study is to investigate the effect of pretreatment with intravenous Alprostadil on the incidence of CIN in a high-risk population of patients with both type 2 diabetes mellitus (T2DM) and CKD undergoing coronary angiography, and evaluate the influence of such potential benefit on short-term outcome.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alprostadil, Control | Experimental | Alprostadil interventions: Alprostadil 40 ug + 1cc/kg/hr normal salin 6 hour before and after angiography AND Control interventions:Normal salin 1cc/kg/hr before and after angiography |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alprostadil ï¹ control | Drug | control:Normal salin 1cc/kg/hr before and after angiography |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Outcome | An absolute increase in SCr >=0.5mg/dL(>=44.2μmmol/L)or a >= 25% increase in SCr from baseline to 72h after the procedure | 72 h |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Outcome | 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. | 30 d |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ya-Wei Xu, MD, FACC | Department of Cardiology, Shanghai Tenth People's Hospital, Tongji University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Cardiology, Shanghai Tenth People's Hospital | Shanghai | Shanghai Municipality | 200072 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10607766 | Result | Koch JA, Plum J, Grabensee B, Modder U. Prostaglandin E1: a new agent for the prevention of renal dysfunction in high risk patients caused by radiocontrast media? PGE1 Study Group. Nephrol Dial Transplant. 2000 Jan;15(1):43-9. doi: 10.1093/ndt/15.1.43. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D003920 | Diabetes Mellitus |
| D058186 | Acute Kidney Injury |
| D007676 | Kidney Failure, Chronic |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000527 | Alprostadil |
| ID | Term |
|---|---|
| D011458 | Prostaglandins E |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D052801 | Male Urogenital Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D051436 | Renal Insufficiency, Chronic |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005227 |
| Fatty Acids |
| D008055 | Lipids |
| D005229 | Fatty Acids, Monounsaturated |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |