Efficacy and Safety of Alprostadil Prevent Contrast Induced Nephropathy

NCT01722513 | Unknown Phase 4 DMC

• 1 other identifier: NCT20120312
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Kidney Diseases; Diabetes Mellitus; Acute Kidney Injury; Kidney Failure, Chronic; Renal Insufficiency

Keywords

Contrast Induced Nephropathy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Secondary Outcome

  30 d

Study Arms (1)

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

Drug: Alprostadil ﹠control

Interventions

Alprostadil ﹠control DRUG

control:Normal salin 1cc/kg/hr before and after angiography

Also known as: Drug: Alprostadil, lipo-alprostadil, Prostaglandin E1, Drug: normal salin

Alprostadil, Control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient that underwent coronary angiography
• T2DM
• CKD stages 2 and 3, eGFR 30 to 89ml/min per 1.73m2
• Alprostadil naive, or not on Alprostadil treatment for at least 14 days
• Withdrawal metformin or aminophylline for 48h before angiography

You may not qualify if:

• serum Cr. More than 3 mg/dl
• electrolyte and acid-base imbalance
• pulmonary edema
• allergy to Alprostadil

Sponsors & Collaborators

• Shanghai 10th People's Hospital: lead

Study Sites (1)

Department of Cardiology, Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, 200072, China

Location

Related Publications (1)

• 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.

  PMID: 10607766 RESULT

MeSH Terms

Conditions

Kidney Diseases; Diabetes Mellitus; Acute Kidney Injury; Kidney Failure, Chronic; Renal Insufficiency

Interventions

Alprostadil

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Renal Insufficiency, Chronic; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostaglandins E; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Fatty Acids, Monounsaturated; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Ya-Wei Xu, MD, FACC

  Department of Cardiology, Shanghai Tenth People's Hospital, Tongji University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD FACC

Study Record Dates

• First Submitted: November 3, 2012
• First Posted: November 7, 2012
• Study Start: November 1, 2012
• Primary Completion: November 1, 2013
• Study Completion: February 1, 2014
• Last Updated: November 7, 2012

Record last verified: 2012-11

Locations

CN (1)