Clinical trial NCT00312117: Trial for Prevention of Contrast Nephropathy With Sodium Bicarbonate
Official title: A Randomized Trial for Prevention of Contrast Nephropathy With Sodium Bicarbonate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Contrast Induced Nephropathy
Kidney Diseases
Keywords: contrast induced nephropathy
sodium bicarbonate
cardiac catheterization
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
First posted: 2006-04-07
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: development of contrast induced nephropathy, defined by a decrease in glomerular filtration rate (GFR) by 25% or more
Secondary outcomes:
measure: change in serum creatinine
measure: difference in hospital duration between groups
measure: need for hemodialysis
measure: 30 day mortality
measure: difference of baseline to lowest GFR and highest creatinine between groups
measure: difference in GFR and creatinine from baseline and 2-8 weeks later
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Kaiser Permanente Medical Center
state: California
Study officials:
affiliation: Kaiser Permanente
name: Somjot S Brar, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Briguori C, Tavano D, Colombo A. Contrast agent--associated nephrotoxicity. Prog Cardiovasc Dis. 2003 May-Jun;45(6):493-503. doi: 10.1053/pcad.2003.YPCAD16.
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. doi: 10.1016/s0002-9343(97)00150-2.
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. doi: 10.1016/j.jacc.2004.07.043.
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. doi: 10.1001/jama.291.19.2328.
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. doi: 10.1161/01.cir.0000016043.87291.33.
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. doi: 10.1056/NEJM198901193200303.
citation: Brar SS, Shen AY, Jorgensen MB, Kotlewski A, Aharonian VJ, Desai N, Ree M, Shah AI, Burchette RJ. Sodium bicarbonate vs sodium chloride for the prevention of contrast medium-induced nephropathy in patients undergoing coronary angiography: a randomized trial. JAMA. 2008 Sep 3;300(9):1038-46. doi: 10.1001/jama.300.9.1038.