ANDROMEDA-SHOCK

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Clinical Question

In patients with septic shock, is there a mortality benefit associated with utilizing capillary refill time over serum lactate measurements to guide resuscitation?

Bottom Line

There is no mortality benefit associated with using capillary refill time to guide resuscitation efforts compared to lactate measurements in septic shock.

Major Points

Several small and large randomized trials in diabetics had previously suggested a sizable benefit of tight glycemic control in reducing cardiovascular risk. The ACCORD trial was the largest study of its kind and demonstrated that not only does euglycemia (ie, HbA1c <6%) not reduce cardiovascular risk, it also is associated with a trend towards increased mortality.

Guidelines

There are no current guidelines reflecting this study.

Design

  • Multicenter, randomized, controlled trial
  • N=424
    • Capillary refill group (n=212)
    • Serum lactate measurement group (n=212)
  • Setting: 28 hospitals in 5 countries (Argentina, Chile, Colombia, Ecuador, and Uruguay)
  • Enrollment: March 2017 to March 2018
  • Analysis: Intention-to-treat
  • Primary outcome: All-cause mortality at 28 days

Population

Inclusion Criteria

  • Age >18 years
  • Septic shock diagnosed at ICU admission (Requiring vasopressors to maintain MAP >65 and serum lactate >2.0mmol/L despite 20ml/kg of IV fluid resuscitation within an hour

Exclusion Criteria

  • Pregnancy
  • Anticipated need for surgery or dialysis within 8 hours of admission
  • Do-not-resuscitate status
  • Child B/C liver cirrhosis
  • Active bleeding
  • Acute hematological malignancy
  • Severe Acute Respiratory Distress Syndrome
  • Delay of >4 hours from septic shock diagnosis to inclusion in study

Baseline Characteristics

From capillary refill group

  • Age = 62 years
  • Male = 51%
  • APACHE II score = 21.9
  • SOFA score = 9.7
  • Serum lactate level = 4.6
  • Septic source = Intra-abdominal (34%), Pneumonia (33%), UTI (20%), Other source (9%), Unknown (5%)

Interventions

  • Randomized to intensive (targeting HbA1c <6%) or standard (HbA1c 7-7.9%) glycemic therapy

    • Then 46% were randomized to intensive (SBP <120) vs. standard (SBP <140) blood pressure therapy
    • Remaining 54% randomized to fenofibrate vs. placebo; all received statin
  • Intensive glycemic control group attended monthly visits for 4 months, then every 2 months, with additional visits and telephone calls as needed
  • Standard therapy group had glycemic control visits every 4 months

Outcomes

Comparisons are capillary refill group vs. serum lactate measurement group.

Primary Outcomes

28-day mortality
35% vs. 43% (HR 0.75; 95% CI 0.55-1.02; P=0.06)

Secondary Outcomes

90-day mortality
41% vs. 47% (HR 0.82; 95% CI 0.61-1.09; P=0.17)
SOFA score at 72 hours
5.6 vs. 6.6 (P=0.045)
Mechanical ventilation-free days within 28 days
14.6 vs. 12.7 (P=0.14)
Vasopressor-free days within 28 days
16.7 vs 15.1 (P=0.18)
Renal replacement-free days within 28 days
18.5 vs. 16.9 (P=0.31)
ICU length of stay (days)
9.1 vs. 9.0 (P=0.91)
Hospital length of stay (days)
22.9 vs. 18.3 (P=0.05)
Amount of resuscitation fluid within first 8 hours
2359ml vs. 2767ml (P=0.01)

Subgroup Analysis

Adverse Events

Criticisms

Funding

Further Reading