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The IDEAL Study Reference
Cooper BA, and the IDEAL study group. A randomized controlled trial of early versus late initiation of dialysis. N Engl J Med [Accessed on: 8 July 2010].
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Background There is tremendous variation in the time for initiation of maintenance dialysis for patients with stage V chronic kidney disease (CKD). This study examines the importance of timing in early initiation of dialysis in patients with CKD.
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Aim To determine whether initiating dialysis early in people with stage V CKD reduces the rate of death from any cause.
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Method Study design: The IDEAL trial was multicenter randomized trial. Study population: A total of 542 patients with diabetes and a mean age of 60.4 years were enrolled in this study. Treatment regimen: The patients were assigned randomly to start dialysis either when the GFR was 10.0–14.0 ml/min (early start group) or to receive dialysis when the GFR was 5.0–7.0 ml/min (late start group). End point: The primary outcome was death due to any cause. The secondary outcome included cardiovascular events (like fatal, non-fatal myocardial infarction, non-fatal stroke, new onset angina), infectious diseases and dialysis complications.
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Result The median time to initiating dialysis was 1.80 months in the early start group and 7.40 months in the late start group. 75.9% patients in the late start group initiated dialysis symptomatically when the GFR was above 7.0 ml/min. 37.7% patients died in the early start group while 36.6% died in the late start group. A significant difference was not observed in the frequency of adverse events and survival rates in both the groups.
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Conclusion This study shows that in patients with progressive chronic kidney disease, initiation of dialysis earlier does not alter the clinical outcome (including survival). The study shows that clinical management of dialysis can be delayed till the GFR drops below 7.0 ml/min. The IDEAL study shows in patients with progressive chronic kidney disease, the initiation of dialysis does not alter the clinical outcome (including survival).
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Result After 4 weeks, the LDL cholesterol levels in the atorvastatin group were reduced by 42% as compared to 13% in the placebo group. However, over the follow-up time of 4 years, the reduction in LDL cholesterol levels did not alter the primary end point of cardiovascular death, MI or stroke. The treatment showed no effect on the primary end point except for fatal stroke which significantly increased in the atorvastatin group. The cardiac events were reduced in the atorvastatin group but there was no reduction in the cerebrovascular events or mortality thereby. There was no effect on the sudden cardiac deaths, which are normally reduced by statin therapy.
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Conclusion In patients with type 2 diabetes on maintenance hemodialysis, routine statin treatment does not reduce the primary end point of death from cardiac causes, myocardial infarction or stroke. The routine statin treatment in patients with type 2 diabetes on maintenance hemodialysis has not reduce the death from cardiac causes, MI or stroke.
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