Unit-IV; Professional Sales Representative (PSR).pptx
SALT-E 3
1. IDEAL:
A RANDOMIZED, CONTROLLEDTRIAL
OF EARLYVERSUS LATE INITIATION OF
DIALYSIS
COOPER BA, ET AL. "A RANDOMIZED, CONTROLLED TRIAL OF EARLYVERSUS LATE
INITIATION OF DIALYSIS". THE NEW ENGLAND JOURNAL OF MEDICINE. 2010. 363(7):609-619.
SALTE E: OVMC LANDMARK TRIAL SERIES
2016
HTTP://TINYURL.COM/SALTE3
2. SUBJECT
Before this landmark trial, there were just non-randomized observational studies
Prior studies showed mixed survival benefit on early initiation of dialysis
3. QUESTION
In person with stageV CKD, is there a difference in survival or clinical outcomes
between early or late initiation of dialysis?
4. DESIGN
Multicenter, parallel-group, randomized, controlled trial
Year: 2000-2008
Location: 32 centers in Australia and New Zealand
Duration: 3.6 years follow up
Analysis: intention-to-treat
5. POPULATION
Subjects: 828 patients w/ StageV CKD
Early dialysis: (n=404)
GFR 10-14 ml/min
Late dialysis: (n=424)
GFR 5-7 ml/min
OR physicians’ discretion (uremic symptom,or electrolyte)
Regimen of peritoneal dialysis vs. hemodialysis at discretion of physician and patient
6. OUTCOME
Primary Outcome
All-cause mortality: 10.2 (early) vs. 9.8 (late)
(HR 1.04, p = 0.75)
Secondary Outcome
CV events (CV death, nonfatal MI/stroke/TIA/angina): 10.9 vs. 8.8 (HR 1.23, p=0.09)
ID events (death form infection, hospitalization): 12.4 vs. 14.3 (HR 0.87, p=0.2)
Temporary catheter placement: 10 vs. 9.7 (p=0.85)
Need for access revision: 13.2 vs. 12.4 (p=0.54)
Serious fluid or electrolyte disorder: 13.2 vs. 15 (p=0.26)
Time to initiation of dialysis: 1.8 vs. 7.4 months (HR 2.09, p<0.001)
7. CRITICISMS
No standardized assessment of creatinine was used
The Cockcroft-Gault equation was used rather than MDRD (more accurate
assessment of GFR)
8. BOTTOM LINE
In patients w/ StageV CKD, there was no difference in survival or clinical
outcome between initiating dialysis earlier vs. later.
9. DISCUSSION QUESTIONS
In this study, what are the two criteria of GFR ranges that help to assign patient
to early vs. late trials?
What are the indications to start dialysis in late arm?
In which arms (early vs. late) would you expect the composite infectious events
to be significantly higher?
What are the primary outcome of this study
What is one criticism of this study?
10. CLINICAL APPLICATION
A stageV CKD pt was admitted to your team for SOB, with x-ray
showing enlarged heart and bilateral cephalization of pulmonary
vessels. PE significant for sacral and pitting edema. Lab significant for
potassium 5.6, BUN 50, GFR 10. You are renal consult.Would you
recommend to start dialysis or not?