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The efficacy of alprostadil in the prevention of contrast-induced nephropathy in the diabetes patients after lower extremity arterial intervention operation

The efficacy of alprostadil in the prevention of contrast-induced nephropathy in the diabetes patients after lower extremity arterial intervention operation

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-16008892
Enrollment
Unknown
Registered
2016-07-23
Start date
2016-07-13
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Contrast-induced nephropathy

Interventions

standard rehydration therapy group:standard rehydration therapy
Alprostadil therapy group:Based on standard hydration therapy combined with the Alprostadil therapy

Sponsors

Department of Endocrinology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. A definitive diagnosis of diabetes with the standard of FDA(2009); 2. colour doppler imaging show the maximal Congestion degree of the any artery of lower extremity =30%; 3. TcPO2<40mmHg; 4. Aged between 40 to 80 years; 5. Voluntary participation and sign a consent form.

Exclusion criteria

Exclusion criteria: 1. Subjects Participated in other clinical trials within 90 days before the random trail or has received any clinical research subjects before the random trail within 30 days; 2. Contrast allergy or cannot tolerate antiplatelet agents (aspirin) of the subjects; 3. Serious, Clotting disorders, or has hemorrhagic disease or heart cerebrovascular accident within 6 months prior to screening visit; 4. Systolic blood pressure =180 mmHg and diastolic blood pressure=110 mmHg or higher and/or diastolic blood pressure after 2 weeks conventional treatment is still higher than 170/100 mmHg blood pressure; The day before treatment or study blood volume deficiencies, hemodynamic instability, systolic blood pressure < 90 mmHg; 5. New York heart association class III or IV heart failure of the subjects (stable I or II level and is undergoing treatment of subjects can be used as the candidate of this study). Or serious heart rhythm disorders; 6. Subjects had obvious clinical symptoms or signs of liver disease, acute or chronic hepatitis, or alanine aminotransferase (ALT) more than three times the upper limit of normal; 7. Acute renal failure or chronic renal insufficiency (eGFR < 15 ml/min / 1.73 m2) or line of dialysis therapy; 8. Use contrast material examination or treatment before the research within 7 days or after the research within one month; 9. Use of cox-2 inhibitors, NSAIDS (not including low-dose aspirin), amino sugar glycosides or any other significant renal toxicity of drugs before the research within 3 days or after the research within one month; 10. Had a history of mental illness to check no cooperation or cannot lay down for a long time of subjects; 11. Subjects suffering from serious illness or debilitating, researchers determine that makes them unable to finish this study; 12. Women in pregnancy or lactation or prepare pregnancy before this study, or within 30 days after the end of the study; 13. Can't claim or compliance with long-term follow-up; 14. Researchers think that may influence the subjects to participate in the test or the results of evaluation of any factors.

Design outcomes

Primary

MeasureTime frame
serum creatinine;bladder inhibition C In the serum and urine;Neutrophil gelatinase-associated lipocalin, NGAL;Liver-type fatty acid binding protein;Adiponectin and HMW-adiponectin HMW/Total adiponectin;

Countries

China

Contacts

Public ContactLiu Dan

Department of Endocrinology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University

liudanye66@126.com+86 13728067086

Outcome results

None listed

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