Dataset Information

Lactate clearance vs central venous oxygen saturation as goals of early sepsis therapy: a randomized clinical trial.

ABSTRACT:

Context

Goal-directed resuscitation for severe sepsis and septic shock has been reported to reduce mortality when applied in the emergency department.

Objective

To test the hypothesis of noninferiority between lactate clearance and central venous oxygen saturation (ScvO2) as goals of early sepsis resuscitation.

Design, setting, and patients

Multicenter randomized, noninferiority trial involving patients with severe sepsis and evidence of hypoperfusion or septic shock who were admitted to the emergency department from January 2007 to January 2009 at 1 of 3 participating US urban hospitals.

Interventions

We randomly assigned patients to 1 of 2 resuscitation protocols. The ScvO2 group was resuscitated to normalize central venous pressure, mean arterial pressure, and ScvO2 of at least 70%; and the lactate clearance group was resuscitated to normalize central venous pressure, mean arterial pressure, and lactate clearance of at least 10%. The study protocol was continued until all goals were achieved or for up to 6 hours. Clinicians who subsequently assumed the care of the patients were blinded to the treatment assignment.

Main outcome measure

The primary outcome was absolute in-hospital mortality rate; the noninferiority threshold was set at Delta equal to -10%.

Results

Of the 300 patients enrolled, 150 were assigned to each group and patients were well matched by demographic, comorbidities, and physiological features. There were no differences in treatments administered during the initial 72 hours of hospitalization. Thirty-four patients (23%) in the ScvO2 group died while in the hospital (95% confidence interval [CI], 17%-30%) compared with 25 (17%; 95% CI, 11%-24%) in the lactate clearance group. This observed difference between mortality rates did not reach the predefined -10% threshold (intent-to-treat analysis: 95% CI for the 6% difference, -3% to 15%). There were no differences in treatment-related adverse events between the groups.

Conclusion

Among patients with septic shock who were treated to normalize central venous and mean arterial pressure, additional management to normalize lactate clearance compared with management to normalize ScvO2 did not result in significantly different in-hospital mortality.

Trial registration

clinicaltrials.gov Identifier: NCT00372502.

SUBMITTER: Jones AE

PROVIDER: S-EPMC2918907 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundSerum lactate and central venous oxygen saturation (ScvO2) are commonly used and commonly recommended as markers of tissue oxygenation in shock states. Medical literature has both explicitly stated and implied that the two biomarkers are interchangeable in the management of patients with shock. However, there have been relatively few direct comparisons of these tests in clinical circumstances, and the relationship between them is uncertain. The objective of our study was to evaluate whether simultaneous or near-simultaneous measurements of lactate and ScvO2 reveal a consistent relationship between these two biomarkers.MethodsA retrospective cohort study was conducted in an urban, academic US hospital. All adults in ICUs between March 2007 and March 2017 who had a lactate measurement and ScvO2 or mixed venous oxygen saturation (SvO2) measurement made +/- 1 h from the lactate were included. Linear and non-linear correlations of ScvO2 and lactate were assessed in a variety of shock states.ResultsTwo thousand sixty-two patients were included. Lactate and ScvO2 correlated poorly (r 2 = 0.0041, p = 0.0019). This was true for patients with ScvO2 ≤ 65% (r 2 = 0.0431, p < 0.001), patients with normal kidney and liver function (r 2 = 0.0517, p < 0.001), and septic shock patients (r 2 = 0.0037, p = 0.17). For patients with an O2 extraction ratio ≥ 50%, lactate and ScvO2 were strongly correlated (r 2 = 0.93, p = 0.0019), but these patients represented only 2.8% of patients in whom the ratio could be calculated.ConclusionsLactate can predict ScvO2 when patients are at or below the critical oxygen delivery threshold, but relatively few shock patients meet this criterion. In the overall population of critically ill patients, serum lactate predicts ScvO2 poorly, even after controlling for factors that may affect lactate production. Lactate and ScvO2 should not be assumed to be interchangeable markers of tissue oxygenation/perfusion.

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