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Efficacy and Safety of Alprostadil Prevent Contrast Induced Nephropathy

NCT ID: NCT01722513

Last Updated: 2012-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2014-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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

Keywords

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Contrast Induced Nephropathy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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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

Group Type EXPERIMENTAL

Alprostadil ﹠control

Intervention Type DRUG

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

Interventions

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Alprostadil ﹠control

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

Intervention Type DRUG

Other Intervention Names

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Drug: Alprostadil lipo-alprostadil Prostaglandin E1 Drug: normal salin

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shanghai 10th People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ya-Wei Xu

MD FACC

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ya-Wei Xu, MD, FACC

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Department of Cardiology, Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

References

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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.

Reference Type RESULT
PMID: 10607766 (View on PubMed)

Other Identifiers

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NCT20120312

Identifier Type: -

Identifier Source: org_study_id