Pulmonary Embolism Clinical Trial
Official title:
Prognostic Value of Plasma Lactate Levels Among Patients With Acute Pulmonary Embolism: the Thrombo-Embolism Lactate Outcome Study
To prospectively investigate the association between plasma lactate concentration and short-term adverse outcomes in patients with acute PE.
Pulmonary embolism (PE) represents 0.4% of hospitalizations and is the third leading cause
of death due to cardiovascular disease (1). In contrast to stroke and acute coronary
syndromes, its mortality has not decreased in recent decades likely due to only minor
advances in short-term prognostication and treatment strategies (2).The presence of shock or
hypotension remains the principal prognostic clinical marker and,to date, is the only factor
that clearly indicates a more aggressive treatment than heparin (3). However, only 5% of
patients with acute PE present with shock. The majority of PE patients are normotensive and
are usually treated with heparin alone. Several studies have looked for new prognostic
indicators in order to better stratify normotensive PE patients. A large body of evidence
shows that right ventricular dysfunction/injury markers such as elevation of brain
natriuretic peptides, troponins, and echocardiographic evidence of right ventricular
dysfunction (RVD) are associated with adverse prognosis (3-8). However, these markers have
some important limitations. Echocardiography is usually not available around-the-clock in
most clinical settings, moreover it shares with troponins and natriuretic peptides a good
negative predictive value (>90%) but a low positive predictive value (about 10%) for
short-term mortality, probably precluding these markers' usefulness to target more
aggressive treatments (8).
Plasma lactate concentration is a marker of the severity of the tissue oxygen
supply-to-demand imbalance. It may reflect tissue hypoperfusion also in the presence of
normal blood pressure. Accordingly, in other critical settings such as sepsis,plasma lactate
concentration is considered to be an accurate prognostic marker as it rises before
hemodynamic impairment is clinically evident (9). Furthermore, plasma lactate concentration
can be easily and rapidly assayed on arterial blood samples using a blood gas analyzer,
which is usually available in emergency departments (EDs) and intensive care units.
Recently, a retrospective study showed that plasma lactate ≥ 2 mmol/L was associated with a
high mortality rate in patients with acute PE (10). Moreover a prospective monocentric study
confirmed these retrospective results and revealed that plasma lactate has prognostic
relevance beyond known clinical and instrumental prognostic markers (TELOS study, Ann Emerg
Med, in press, see attached file)
The aim of present study is to prospectively investigate the association between plasma
lactate concentration and short-term adverse outcomes in patients with acute PE. In
particular, we examine whether high plasma lactate (≥ 2 mmol/L) is associated with a high
incidence of PE related major adverse events, defined as PE related death or hemodynamic
collapse >10% within 7 days of follow-up. Moreover we investigate whether plasma lactate
shows incremental prognostic value to clinically overt hemodynamic impairment and to
RVD/injury markers, maintaining prognostic relevance in both hypotensive and normotensive PE
patients.
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Observational Model: Cohort, Time Perspective: Prospective
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