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Sodium Bicarbonate for the Prevention of Contrast Induced Nephropathy: A Meta-analysis of Published Clinical Trials

Sodium Bicarbonate for the Prevention of Contrast Induced Nephropathy: A Meta-analysis of Published Clinical Trials. Vijayalakshmi Kunadian 1,2 , Azfar Zaman 1 , Weiliang Qiu 2 1 Freeman Hospital, Newcastle upon Tyne, United Kingdom;

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Sodium Bicarbonate for the Prevention of Contrast Induced Nephropathy: A Meta-analysis of Published Clinical Trials

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  1. Sodium Bicarbonate for the Prevention of Contrast Induced Nephropathy: A Meta-analysis of Published Clinical Trials Vijayalakshmi Kunadian1,2, Azfar Zaman1, Weiliang Qiu2 1 Freeman Hospital, Newcastle upon Tyne, United Kingdom; 2 The James Cook University Hospital, Middlesbrough, United Kingdom; 3 Channing Laboratory, Brigham and Women’s Hospital, Boston MA SCAI Annual Scientific Sessions 2009 Las Vegas The authors have nothing to disclose

  2. Background • Contrast induced nephropathy (CIN) is a serious but rare complication following contrast based procedures • Sodium bicarbonate has been demonstrated to prevent CIN through several mechanisms

  3. Objective To perform a meta-analysis ofrandomized clinical trials to determine if the administration of NaHCO3 is superior to NaCl among patients with chronic renal failure undergoing catheterization and interventional procedures in preventing CIN

  4. Study Selection • A computerized literature search was performed on PubMed using the search terms “contrast nephropathy”, “sodium bicarbonate (NaHCO3)”, “sodium chloride” (NaCl) and “renal failure”. • Seven published randomized clinical trials comparing NaHCO3 vs. placebo or NaCl during diagnostic and interventional procedures requiring contrast media administration were included.

  5. RCTs Included in the Meta-analysis CKD-chronic kidney disease, CA-coronary angiography, PCI-Percutaneous coronary intervention, PA-pulmonary angiography, NAC-N-acetylcysteine

  6. Outcome Measures • The development of CIN following administration of NaHCO3 and NaCl are provided. • For the purpose of this meta-analysis, CIN was defined as reported in each of the individual trials. • All studies describe CIN as ≥25% decrease in glomerular filtration rate (GFR) or an absolute increase of serum creatinine ≥0.5 mg/dl on days 1-5 following the procedure. • Four trials (Brar, Maioli, Masuda and Recio-Mayoral) also report clinical outcomes on death, dialysis, myocardial infarction and cerebrovascular events. The occurrence of death, congestive heart failure and the need for renal replacement therapy between the two groups were evaluated from these trials.

  7. Statistical Analysis • DerSimonian and Laird’s random effects model was utilized to pool the odds ratios (ORs) from individual trials. • Cochran’s Q test was used to evaluate heterogeneity. • Light and Pillemer’s funnel plot and Egger et al.’s regression-based method were used to assess publication bias. • Duval and Tweedie’s trim-and-fill method was used to adjust for any observed publication bias. • All analyses were undertaken in statistical software R.

  8. Baseline Characteristics Data are presented as weighted mean+/-SD and weighted number of events (%)

  9. Baseline Characteristics Data are presented as weighted mean+/-SD and weighted number of events (%), ARB-angiotensin receptor blocker, CCB-calcium channel blocker

  10. Development of CIN:All Patients Study NaHCO3 NaCl OR 0.33 (0.16, 0.69), P=0.003 Favours NaHCO3 Favours NaCl Duval and Tweedie’s trim-and-fill adjustment for publication bias showed there was an attenuated OR of 0.55 (95% CI 0.27-1.10; P=0.09) among all patients.

  11. Development of CIN:Renal Failure Patients Study NaHCO3 NaCl OR 0.41 (0.20, 0.82), P=0.01 Favours NaHCO3 Favours NaCl Duval and Tweedie’s trim-and-fill adjustment for publication bias showed there was an attenuated odds ratio of 0.70 (95% CI 0.35-1.43; P=0.33).

  12. Development of CIN: Among Patients Who Received NAC Study NaHCO3 NaCl OR 0.12 (0.04, 0.42), P=0.0008 Favours NaHCO3 Favours NaCl NAC-N-acetylcysteine

  13. Need for Renal Replacement Therapy Study NaHCO3 NaCl OR 0.56 (0.22, 1.41), P=0.22 Favours NaHCO3 Favours NaCl

  14. Clinical Endpoint: Death Study NaHCO3 NaCl OR 0.60 (0.26, 1.41), P=0.24 Favours NaHCO3 Favours NaCl

  15. Clinical Endpoint: Heart Failure Study NaHCO3 NaCl OR 0.85 (0.32, 2.24), P=0.74 Favours NaHCO3 Favours NaCl

  16. Limitations • The results observed here may not be applicable to all patients in clinical practice. • The present study remains subject to the inherent caveats of a meta-analysis including publication-bias. • Patient level data was not available in this study. • The dose of NaHCO3 varied across the trials.

  17. Conclusions The present meta-analysis demonstrates that based on currently available randomized trials, the administration of NaHCO3 is superior to administration of NaCl alone in the prevention of CIN among patients with moderate to severe CKD undergoing diagnostic and interventional procedures requiring contrast media.

  18. Conclusions • The use of NaHCO3 however, did not result in significant benefit in terms of reductions in death, heart failure and the requirement for renal replacement therapy. • The results of this study should be considered in the context of publication bias inherent to meta-analysis. • Adequately powered studies are required to determine the beneficial effect of NaHCO3 in preventing CIN and improving short-term and long-term clinical outcomes among patients who undergo coronary diagnostic and interventional procedures requiring contrast media.

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