Trial for Prevention of Contrast Nephropathy With Sodium Bicarbonate

Kidney Diseases Clinical Trial

Official title:

A Randomized Trial for Prevention of Contrast Nephropathy With Sodium Bicarbonate

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00312117
• Other study ID #: 4353
• Status: Completed
• Phase: Phase 3
• First received: April 5, 2006
• Last updated: March 10, 2015
• Start date: January 2006
• Est. completion date: February 2006

Study information

• Verified date: March 2015
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Contrast nephropathy (CN) is a common cause of renal failure associated with prolonged hospitalization, significant morbidity/mortality, and cost. In addition, these patients may require temporary or permanent hemodialysis which, in turn, is associated with further morbidity, mortality, and cost. CN has been reported to account for 10% of hospital acquired renal failure. In recent years, studies have investigated preventive therapies with mixed results. Fenoldopam was found to be ineffective in a large randomized trial. Dopamine has been shown to be ineffective as a preventive strategy. Hemofiltration has been shown to be beneficial (New England Journal of Medicine [NEJM] 2003) but is costly and not practical. Mucomyst has shown mixed results. The single strategy which most would agree as being beneficial remains hydration, most commonly with intravenous 0.9% normal saline. Most recently, sodium bicarbonate has been shown to be beneficial in a small randomized trial (n=119). It is clear that the most cost effective strategies for treatment of CN should be aimed at prevention.

The general question is: "Is a sodium bicarbonate solution more efficacious in preventing contrast nephropathy compared to normal saline?" The general hypothesis is that sodium bicarbonate will be more efficacious.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: February 2006
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• GFR < 60 mL/min/1.73m2. GFR will be adjusted by a correction factor as reported by our laboratory for patients self identifying as black.

• > 18 years and have at least one of the following risk factors for contrast nephropathy: diabetes (type 2), congestive heart failure, hypertension (> 140/90), or age > 75.

• Both inpatients and outpatients will be offered enrollment.

Exclusion Criteria:

• Patients unable to give consent

• Already receiving sodium bicarbonate solution

• Undergoing emergency cardiac catheterization

• Receiving a contrast agent other than Oxilan

• On hemodialysis

• Recent exposure to contrast within 2 days

• Pulmonary edema

• Active congestive heart failure

• Severe valvular abnormality

• Recent significant change in kidney function (> 15% over 2d)

• One kidney

• Kidney transplant status

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Contrast Induced Nephropathy
• Kidney Diseases

Intervention

Drug:
• Sodium bicarbonate

Locations

Country	Name	City	State
United States	Kaiser Permanente Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Kaiser Permanente

Country where clinical trial is conducted

United States, 

References & Publications (6)

Briguori C, Tavano D, Colombo A. Contrast agent--associated nephrotoxicity. Prog Cardiovasc Dis. 2003 May-Jun;45(6):493-503. Review. — 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, Wolyn R, Rocher LL, Levin RN, O'Neill WW. Acute renal failure after coronary intervention: incidence, risk factors, and relationship to mortality. Am J Med. 1997 Nov;103(5):368-75. — View Citation

Merten GJ, Burgess WP, Gray LV, Holleman JH, Roush TS, Kowalchuk GJ, Bersin RM, Van Moore A, Simonton CA 3rd, Rittase RA, Norton HJ, Kennedy TP. Prevention of contrast-induced nephropathy with sodium bicarbonate: a randomized controlled trial. JAMA. 2004 May 19;291(19):2328-34. — View Citation

Parfrey PS, Griffiths SM, Barrett BJ, Paul MD, Genge M, Withers J, Farid N, McManamon PJ. Contrast material-induced renal failure in patients with diabetes mellitus, renal insufficiency, or both. A prospective controlled study. N Engl J Med. 1989 Jan 19;320(3):143-9. — View Citation

Rihal CS, Textor SC, Grill DE, Berger PB, Ting HH, Best PJ, Singh M, Bell MR, Barsness GW, Mathew V, Garratt KN, Holmes DR Jr. Incidence and prognostic importance of acute renal failure after percutaneous coronary intervention. Circulation. 2002 May 14;105(19):2259-64. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	development of contrast induced nephropathy, defined by a decrease in glomerular filtration rate (GFR) by 25% or more
Secondary	change in serum creatinine
Secondary	difference in hospital duration between groups
Secondary	need for hemodialysis
Secondary	30 day mortality
Secondary	difference of baseline to lowest GFR and highest creatinine between groups
Secondary	difference in GFR and creatinine from baseline and 2-8 weeks later