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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03164681
Other study ID # RDWCIN
Secondary ID
Status Not yet recruiting
Phase N/A
First received May 22, 2017
Last updated May 23, 2017
Start date December 1, 2017
Est. completion date December 30, 2018

Study information

Verified date May 2017
Source Assiut University
Contact Mohammed Tohamy, MD
Phone 01227370775
Email proftohammy@yahoo.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Contrast Induced Nephropathy is an acute renal insufficiency defined as a 25% or 0.5 mg/dl increase over the baseline of the serum creatinine level 24 h to 72 h after intravascular administration of a contrast agent.


Description:

Contrast Induced Nephropathy has been introduced an important complication after coronary angiography and Percutaneous Coronary Intervention .

The development of Contrast Induced Nephropathy after Percutaneous Coronary Intervention is associated with poor clinical outcomes including prolonged hospitalization, increased costs, increased rates of end-stage renal failure, myocardial infarction, repeat revascularization, and short- and long-term mortality.

Contrast Induced Nephropathy follows decreased renal perfusion and administration of nephrotoxic medications as the third most common cause of renal insufficiency during hospitalization.

Patients with acute coronary syndrome have a 3-fold higher risk of developing Contrast Induced Nephropathy .Therefore ,predicting contrast nephropathy and initiating therapeutic preventive strategies are very important.

Red Blood Cell Distribution Width is a quantitive marker of the variability on size of erythrocyte.

It is a routine assay of Complete Blood Count that doesn't require an additional cost, that is calculated by dividing the standard deviation of the mean cell size by the Mean Corpuscular Volume of the red cells and multiplying by 100 to convert to a percentage.

Normal range of Red Blood Cell Distribution Width 11-16%. Increased Red Blood Cell Distribution Width means increased variability in red blood cell size owing to ineffective erythrocyte production, which is associated with indices of inflammation and pro-inflammatory cytokines such as interleukin-6 .

On the other hand, suggested mechanisms underlying Contrast Induced Nephropathy include cytotoxic effects, factors that affect renal hemodynamic, and regional hypoxia.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 126
Est. completion date December 30, 2018
Est. primary completion date November 30, 2018
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

Consecutive patients who underwent percutaneous coronary intervention either elective or emergency.

Exclusion Criteria:

1. End stage renal disease with glomerular filtration rate less than 30 ml/1.73.

2. Patient known allergy to contrast agents.

3. Left ventricular ejection fraction below 30%.

4. Presence of infection

5. A recent history of contrast administration in the previous month.

6. Patient known to have thyroid disease.

7. History of malignancy.

8. Patient known to have Autoimmune disease.

9. Decompensated liver cirrhosis

10. Cardiogenic shock.

11. Anemia

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (7)

Bartholomew BA, Harjai KJ, Dukkipati S, Boura JA, Yerkey MW, Glazier S, Grines CL, O'Neill WW. Impact of nephropathy after percutaneous coronary intervention and a method for risk stratification. Am J Cardiol. 2004 Jun 15;93(12):1515-9. — View Citation

Marenzi G, Lauri G, Assanelli E, Campodonico J, De Metrio M, Marana I, Grazi M, Veglia F, Bartorelli AL. Contrast-induced nephropathy in patients undergoing primary angioplasty for acute myocardial infarction. J Am Coll Cardiol. 2004 Nov 2;44(9):1780-5. — View Citation

McCullough PA. Contrast-induced acute kidney injury. J Am Coll Cardiol. 2008 Apr 15;51(15):1419-28. doi: 10.1016/j.jacc.2007.12.035. Review. Erratum in: J Am Coll Cardiol.2008 Jun 3;51(22): 2197. — View Citation

Mehran R, Nikolsky E. Contrast-induced nephropathy: definition, epidemiology, and patients at risk. Kidney Int Suppl. 2006 Apr;(100):S11-5. Review. — View Citation

Nash K, Hafeez A, Hou S. Hospital-acquired renal insufficiency. Am J Kidney Dis. 2002 May;39(5):930-6. — View Citation

Seeliger E, Sendeski M, Rihal CS, Persson PB. Contrast-induced kidney injury: mechanisms, risk factors, and prevention. Eur Heart J. 2012 Aug;33(16):2007-15. doi: 10.1093/eurheartj/ehr494. Epub 2012 Jan 19. Review. — View Citation

Tepel M, Aspelin P, Lameire N. Contrast-induced nephropathy: a clinical and evidence-based approach. Circulation. 2006 Apr 11;113(14):1799-806. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Contrast Induced Nephropathy Percentage of patients with raised serum creatinine 25% or 0.5 mg/dl over baseline serum creatinine within 48 hour after contrast administration 48 Hours
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