Albumin vs Saline in Resus

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Slide 1: 

A Comparison of Albumin and Saline for Fluid Resuscitation in the Intensive Care Unit The SAFE Study Investigators The New England Journal of Medicine, May 27, 2004. 350;22:2247-2256

Methods - Study Design and Treatment Protocol : 

Methods - Study Design and Treatment Protocol Patient selection >18 yrs old ICU in 16 hospitals in Australia and NZ Between Nov 2001 and June 2003 Required fluid administration Excluded post-op cardiac surgery, liver transplant or burns Intervention Randomly assigned to receive either 4% Albumin or N/S

Method – Non-study fluids : 

Method – Non-study fluids Patients also received Maintenance fluids Specific replacement fluids Enteral/parental nutrition Blood products

Design : 

Design (+) Double-blinded (+) Randomised groups (+) Groups had similar baseline characteristics (+) Prospective trial (+) Multi-centre (+) Large study population (-) Multidisciplinary ICU – patient type not defined

Method - Primary Outcome Measures : 

Method - Primary Outcome Measures Death from any cause within 28 days Subgroups Presence/Absence of trauma Presence/Absence of severe sepsis Presence/Absence of Acute Respiratory Distress Syndrome

Method - Primary Outcome Measures : 

Proportion with 1-5 new organ failures Cardiovascular Respiratory Renal Haematologic Hepatic Duration of mechanical ventilation Duration of renal-replacement therapy Duration of ICU and hospital stay Method - Primary Outcome Measures

Results : 

Results 6997 patients 3497 – Albumin 3500 – Saline (+) Large power study (-) Three patients underwent randomisation twice Counted in group allocated first

Slide 8: 

Consent Delayed from patient or surrogate Prior consent from surrogate Outcomes not available in 67 patients (1% of patients) 56 out of 67 due to withheld or withdrawn consent

Slide 9: 

The only statistically significant difference at baseline Mean CVP - higher in the albumin group

Results - Parameters : 

Results - Parameters Study fluids Albumin group received less than saline group Non-study fluids Day 1+2 – albumin group received more packed cells than saline Day 2 – saline group received more non-study fluids Day 4… - no further differences in volume of study fluids

Slide 11: 

Study fluids Not administed to 197 patients (2.8% of patients) Non-study resuscitation fluids Most commonly due to error Clinician’s preference

Slide 12: 

No significant difference in mean arterial pressure Albumin group had lower heart rate at Day 1 Albumin group had significantly higher CVP throughout D1-4 Serum albumin higher than albumin group

Results - Outcomes : 

Results - Outcomes Death after 28 days 20.9% of albumin group 21.1% of saline group Absolute difference in mortality was -0.2% Remaining in ICU after 28 days 3.2% of albumin group 2.5% of saline group Remaining in Hospital after 28 days 22.8% of albumin group 24.5% of saline group Survival time after 28 days No significant difference between groups

Slide 14: 

Mean length of stay in ICU 6.5 +/- 6.6 days for albumin group 6.2 +/- 6.2 days for saline group Mean length of stay in Hospital 15.3 +/- 9.6 days for albumin group 15.6 +/- 9.6 days for saline group M.O.F. – similar number

Results – Subgroup Analysis : 

Presence of Trauma Death – relative risk 1.36 Absence of Trauma Deaths – relative risk 0.96 Why? Greater number of trauma patients also had associated brain injury in albumin group Results – Subgroup Analysis

Results – Subgroup Analysis : 

Results – Subgroup Analysis Presence of Trauma WITH Brain injury Deaths – relative risk 1.62 24.5% in albumin group 15.1% in saline group Presence of Trauma WITHOUT Brain injury Deaths – relative risk 1.00 (no difference)

Results – Subgroup Analysis : 

Presence of Sepsis Deaths – relative risk 0.87 30.7% in Albumin group 35/3% in Saline group Absence of Sepsis Deaths – relative risk 1.05 Results – Subgroup Analysis

Results – Subgroup Analysis : 

Presence of ARDS Death – relative risk 0.93 Absence of ARDS Death – relative risk 1.00 Results – Subgroup Analysis

Discussion : 

Discussion No difference in… Death from any cause Requirements for mechanical ventilation Requirements for renal-replacement Time spent in ICU Time spent in Hospital Time until death Similar rates of new single/multiple organ failures

Slide 20: 

Albumin group were resuscitated with less fluid than the saline group But no difference in MAP Only small difference in CVP and HR

Slide 21: 

Albumin group receive greater volume of packed cells Why? ? Greater haemodilution with albumin ? Greater blood loss due to transient alterations in coagulation with albumin Is this the cause of higher mortality with albumin? Herbert et al – 3U packed cells associated with higher mortality Albumin group had 71ml extra fluid (1/4U) – enough for an effect??

Slide 22: 

?better result for trauma patients with saline Choi – colloid associated with increased mortality in patients with trauma Trauma with brain injury But… only 7% of study group had brain injury with only 21 more deaths in albumin group than saline – ?chance result For brain injury, should not measure 28 day death rate, but rather mortality and functional neurological status at 6 months

Slide 23: 

Patients with sepsis Differences could be chance – needs further study

Slide 24: 

Patients had differing concurrent interventions across institutions ? But randomised within institution

Conclusion : 

Conclusion Albumin and saline are clinically equivalent treatments for intravascular volume replacement in a heterogeneous population of patients in the ICU

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