Contrast-induced Nephropathy: Incidence,Risk Factors,Effective Prevention and Management Method

Cardio-Renal Syndrome Clinical Trial

Official title:

Chinese People's Liberation Army General Hospital

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02664246
• Other study ID #: 16qqy
• Status: Completed
• Phase: N/A
• First received: January 22, 2016
• Last updated: January 26, 2016
• Start date: January 2015
• Est. completion date: January 2016

Study information

• Verified date: January 2016
• Source: Chinese PLA General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: National Health and Family Planning Commission
• Study type: Observational

Clinical Trial Summary

This review article have included about ten thousand patients undergoing percutaneous coronary intervention (PCI), aim to identify the incidence of CIN in actual, find some new risk factors and the protecting methods for these factors.

Description:

About ten thousand patients undergoing percutaneous coronary intervention (PCI) from 2010 to 2015 are included in this study. We collect the data about the SCr of the patients before and after percutaneous coronary intervention, and define CIN as an increase in SCr of 0.5 mg/dl or 25% from baseline between 48 and 72 h after contrast medium exposure. Besides we obtain the data including clinical characteristics, laboratory data (blood and urine tests) for all the patients. The statistical analysis will find some new risk factors.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10000
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. congestive heart failure: objective evidences for decreased left ventricular eject fraction (LVEF) <= 50%;

2. moderate to severe chronic kidney disease was defined as an eGFR 15 to 59 mL/min per 1.73 m2, calculated via the abbreviated Modification of Diet in Renal Disease (MDRD) study equation from SCr obtained within 72 hours of enrollment;

3. patients were scheduled to undergo diagnostic cardiac angiography or percutaneous coronary interventions.

Exclusion Criteria:

1. hemodialysis-dependent patients;

2. complicated with severe short-term progressive disease;

3. Patients < 18 years;

4. pregnancy;

5. emergency cardiac catheterisation (eg, primary percutaneous coronary intervention for ST-segment elevation myocardial infarction);

6. exposure to radiographic contrast media within the previous 7 days;

7. acute decompensated heart failure.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Cardio-Renal Syndrome

Intervention

Device:
• percutaneous coronary intervention

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

References & Publications (5)

Andreucci M, Faga T, Pisani A, Sabbatini M, Russo D, Michael A. Prevention of contrast-induced nephropathy through a knowledge of its pathogenesis and risk factors. ScientificWorldJournal. 2014;2014:823169. doi: 10.1155/2014/823169. Epub 2014 Nov 30. Review. — View Citation

Brillet G, Aubry P, Schmidt A, Catella L, Julien L, Bénard S. Hospital Costs Of Contrast-Induced Nephropathy. Value Health. 2015 Nov;18(7):A510. doi: 10.1016/j.jval.2015.09.1467. Epub 2015 Oct 20. — View Citation

Qian G, Fu Z, Guo J, Cao F, Chen Y. Prevention of Contrast-Induced Nephropathy by Central Venous Pressure-Guided Fluid Administration in Chronic Kidney Disease and Congestive Heart Failure Patients. JACC Cardiovasc Interv. 2016 Jan 11;9(1):89-96. doi: 10.1016/j.jcin.2015.09.026. Epub 2015 Dec 9. — View Citation

Tao SM, Wichmann JL, Schoepf UJ, Fuller SR, Lu GM, Zhang LJ. Contrast-induced nephropathy in CT: incidence, risk factors and strategies for prevention. Eur Radiol. 2015 Dec 18. [Epub ahead of print] — View Citation

Wichmann JL, Katzberg RW, Litwin SE, Zwerner PL, De Cecco CN, Vogl TJ, Costello P, Schoepf UJ. Contrast-Induced Nephropathy. Circulation. 2015 Nov 17;132(20):1931-6. doi: 10.1161/CIRCULATIONAHA.115.014672. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Contrast induced nephropathy postoperation	peak serum creatinine increase of either 0.5 mg/dl or 25% from day 0 through day 7	7 days	Yes
Secondary	Composite measure of dialysis or main cardiovascular events	dialysis, myocardial infarction, heart failure and all-cause death	90 days	Yes