Named Studies

Question 1

VIOLET Study (2020) (Vitamin D to Improve Outcomes by Leveraging Early Treatment)

Answer 1

• randomized, double-blind, placebo-controlled, phase 3 trial of early vitamin D3 supplementation in critically ill, vitamin D–deficient patients who were at high risk for death
• Early administration of high-dose enteral vitamin D3 did not provide an advantage over placebo with respect to 90-day mortality or other, nonfatal outcomes among critically ill, vitamin D–deficient patients.

Question 2

ELAIN Study (2016) (Effect of Early vs Delayed Initiaion of Renal Replacement Therapy on Mortality)

Answer 2

• Single-center randomized clinical trial of 231critically ill patients with AKI Kidney Disease: Improving Global Outcomes (KDIGO) stage 2(2 times baseline or urinary output <0.5 mL/kg/h for12 hours)
• Early (within 8 hours of diagnosis of KDIGO stage 2; n = 112) or delayed (within 12 hours of stage 3 AKI or no initiation; n = 119) initiation of RRT
• 90 day mortality Early group 39.3% vs Delayed group 54.7%
• Length of hospital stay: 51 days vs 82 days
• Median duration of mechanical ventilation: 125.5 hrs vs 181.0 hrs (P = 0.002)

Question 3

STAART-AKI (2020)(STandard versus Accelerated Initiation of Renal Replacement Therapy in Acute Kidney Injury trial)

Answer 3

• Multinational, multi center randomized controlled trial
• Early (KDIGO stage 2 or 3 AKI with initiation of RRT within 12 hours) compared to standard therapy
• No difference in 90 day mortality
• More patients requiring long term RRT in early group and more adverse events in early group.

Question 4

VANISH (2016) (Early Vasopressin vs Norepinephrine on Kidney Failure in Patients with Septic Shock)

Answer 4

• A factorial (2x2), randomized, double-blind clinical trial
• Comparing vasopressin as a first line vasoactive medication compared to norepinephrine
• No different in kidney-failure free days (primary outcome)

Question 5

PICARD study (2002)(Project to Improve Care in Renal Disease)

Answer 5

• Retrospective Cohort Study with Propensity Matched score
• Diuretic use was more likely to be associated with death or nonrecovery of renal function (OR 1.68, 1.79)
• Not a great study. Low numbers with differences in baseline characteristics. Multiple diuretics used. Retrospective. Data from 80s. Single region.
• Contrast with Prospective observational study published in 2004 with more rigorous stats. Did not show statistically significant association between diuretics and mortality. But also did not show benefit.

Question 6

SAFE (2004) (Saline vs Albumin Fluid Evaluation)

Answer 6

• Prospective, multi center, randomized, double blind trial
• Excluded cardiac surgery, liver transplant, and burn surgery
• no difference in mortality at 28 days, ICU days, hospital stay, mechanical ventilation days, or days of RRT between 4% albumin vs 0.9% saline.
• Maybe advantage to albumin in severe sepsis (mortality OR 0.87)

Question 7

ALBIOS (2014) (Albumin Italian Outcome Sepsis Study)

Answer 7

• Multi center, open - label, randomized trial
• 20% albumin + crystalloid (targeting serum albumin 30 g/L) vs crystalloid alone
• No difference in 28 day or 90 day survival
• Post hoc analysis showed 90 day survival benefit of albumin in septic shock but detriment for patients with severe sepsis without shock.