Red Blood Cell Distribution Width as a Marker of Contrast Induced Nephropathy in Patients With Coronary Intervention

Contrast-induced Nephropathy Clinical Trial

Official title:

Red Blood Cell Distribution Width as a Predictor Marker of Contrast Induced Nephropathy in Patients Undergoing Percutaneous Coronary Intervention

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03164681
• Other study ID #: RDWCIN
• 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
• 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

Related Conditions & MeSH terms

• Contrast-induced Nephropathy
• Kidney Diseases

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