Clinical Trial: Prognostic Value of Plasma Lactate Levels Among Patients With Acute Pulmonary Embolism

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Prognostic Value of Plasma Lactate Levels Among Patients With Acute Pulmonary Embolism: the Thrombo-Embolism Lactate Outcome Study

Brief Summary: To prospectively investigate the association between plasma lactate concentration and short-term adverse outcomes in patients with acute PE.

Detailed Summary:

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 a
Sponsor: Azienda Ospedaliero-Universitaria Careggi

Current Primary Outcome: The composite of PE related death or hemodynamic collapse [ Time Frame: 7 days. ]

PE related death was defined as a fatal event occurring in the hours after clinical deterioration due to PE, including an objectively diagnosed recurrent PE, or if death could not be attributed to a documented cause and PE could not be confidently ruled out. Autopsy is not mandatory.

Hemodynamic collapse is defined as at least 1 of the following: (i) the need for cardiopulmonary resuscitation; (ii) systolic blood pressure <90 mm Hg for at least 15 minutes, or drop of systolic blood pressure by at least 40 mm Hg for at least 15 minutes, with signs of end-organ hypoperfusion (cold extremities, or urinary output <30 mL/h, or mental confusion); (iii) the need for catecholamines (except for dopamine at a rate of < 5 μg kg−1 min−1) to maintain adequate organ perfusion and a systolic blood pressure of >90 mm Hg; (iiii) the need for invasive or noninvasive mechanical ventilation; (iiiii) imaging-confirmed symptomatic recurrence of PE within 7 days.



Original Primary Outcome: Same as current

Current Secondary Outcome:

  • all cause death [ Time Frame: 30 days ]
  • PE recurrence [ Time Frame: 30 days ]


Original Secondary Outcome: Same as current

Information By: Azienda Ospedaliero-Universitaria Careggi

Dates:
Date Received: July 23, 2013
Date Started: December 2012
Date Completion:
Last Updated: February 15, 2014
Last Verified: February 2014