DAMIS
Trial question
What is the role of integrating sublingual microcirculatory perfusion variables in the therapeutic management of patients with shock?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
28.0% female
72.0% male
N = 141
141 patients (40 female, 101 male).
Inclusion criteria: patients admitted to the ICU with circulatory shock.
Key exclusion criteria: inaccessibility of the sublingual mucosa; impracticality of measurement during the inclusion period due to examinations/treatments/patient already dying; uncooperative/weakly sedated patients; infectious reasons.
Interventions
N=69 sublingual microcirculatory perfusion measurement (integration of microcirculatory perfusion variables in the therapeutic management).
N=72 usual routine (withholding of microcirculatory perfusion variables in the therapeutic management).
Primary outcome
Death at day 30
47.1%
34.7%
47.1 %
35.3 %
23.6 %
11.8 %
0.0 %
Sublingual microcirculatory perfusion
measurement
Usual
routine
No significant
difference ↔
No significant difference in death at day 30 (47.1% vs. 34.7%; HR 1.54, 95% CI 0.9 to 2.66).
Secondary outcomes
No significant difference in death at 6 months (55.1% vs. 44.4%; HR 1.38, 95% CI 0.86 to 2.11).
No significant difference in length of stay in the ICU (5.5 days vs. 5.5 days; MD -1.44, 95% CI -9.36 to 5.47).
No significant difference in length of hospital stay (12 days vs. 10.5 days; MD -3.33, 95% CI -11.08 to 4.43).
Safety outcomes
No significant differences in RRT, mechanical ventilation.
Conclusion
In patients admitted to the ICU with circulatory shock, sublingual microcirculatory perfusion measurement was not superior to usual routine with respect to death at day 30.
Reference
Raphael Romano Bruno, Jakob Wollborn, Karl Fengler et al. Direct assessment of microcirculation in shock: a randomized-controlled multicenter study. Intensive Care Med. 2023 Jun;49(6):645-655.
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