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Efficacy and Safety of Alprostadil Prevent Contrast Induced Nephropathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01722513
Recruitment Status : Unknown
Verified November 2012 by Ya-Wei Xu, Shanghai 10th People's Hospital.
Recruitment status was:  Active, not recruiting
First Posted : November 7, 2012
Last Update Posted : November 7, 2012
Sponsor:
Information provided by (Responsible Party):
Ya-Wei Xu, Shanghai 10th People's Hospital

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.

Condition or disease Intervention/treatment Phase
Kidney Diseases Diabetes Mellitus Acute Kidney Injury Kidney Failure, Chronic Renal Insufficiency Drug: Alprostadil ﹠control Phase 4

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Phase 4 Study of Alprostadil Prevent Contrast Induced Nephropathy in Patients Receiving a Cardiac Catheterization
Study Start Date : November 2012
Estimated Primary Completion Date : November 2013
Estimated Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
Drug Information available for: Alprostadil

Arm Intervention/treatment
Experimental: Alprostadil, Control
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
control:Normal salin 1cc/kg/hr before and after angiography
Other Names:
  • Drug: Alprostadil
  • lipo-alprostadil
  • Prostaglandin E1
  • Drug: normal salin




Primary Outcome Measures :
  1. Primary Outcome [ Time Frame: 72 h ]
    An absolute increase in SCr >=0.5mg/dL(>=44.2μmmol/L)or a >= 25% increase in SCr from baseline to 72h after the procedure


Secondary Outcome Measures :
  1. Secondary Outcome [ Time Frame: 30 d ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01722513


Locations
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China, Shanghai
Department of Cardiology, Shanghai Tenth People's Hospital
Shanghai, Shanghai, China, 200072
Sponsors and Collaborators
Shanghai 10th People's Hospital
Investigators
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Principal Investigator: Ya-Wei Xu, MD, FACC Department of Cardiology, Shanghai Tenth People's Hospital, Tongji University School of Medicine

Additional Information:
Publications of Results:
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Responsible Party: Ya-Wei Xu, MD FACC, Shanghai 10th People's Hospital
ClinicalTrials.gov Identifier: NCT01722513    
First Posted: November 7, 2012    Key Record Dates
Last Update Posted: November 7, 2012
Last Verified: November 2012
Keywords provided by Ya-Wei Xu, Shanghai 10th People's Hospital:
Contrast Induced Nephropathy
Additional relevant MeSH terms:
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Kidney Diseases
Acute Kidney Injury
Renal Insufficiency
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Alprostadil
Platelet Aggregation Inhibitors
Vasodilator Agents
Urological Agents