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

NCT01908231 | Completed

• 1 other identifier: 0313
• Study Type: observational
• Target: 330
• Locations: 2 countries
• Sites: 4

Brief Summary

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

Conditions

Pulmonary Embolism

Keywords

Pulmonary embolism, plasma lactate, right ventricular dysfunction

Outcome Measures

Primary Outcomes (1)

• The composite of PE related death or hemodynamic collapse

  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.

  7 days.

Secondary Outcomes (2)

• all cause death

  30 days

• PE recurrence

  30 days

Study Arms (1)

Pulmonary Embolism

Consecutive adult patients (minimum age eighteen) who presented to the ED of the hospitals participating in the study with clinical suspicion of PE will be considered for the study. We excluded patients with life expectancies of less than 3 months, and patients with first symptoms 15 days or more before inclusion.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Consecutive adult patients (minimum age eighteen) who presented to the ED of the hospitals participating in the study with clinical suspicion of PE will be considered for the study. We excluded patients with life expectancies of less than 3 months, and patients with first symptoms 15 day or more before inclusion. The diagnosis of PE will be established by spiral computed tomography or by lung scan or a selective pulmonary angiogram. Patients with proven PE who will give written consent to the use of their medical information for research purposes will be enrolled in the study.

You may qualify if:

• Symptomatic objective pulmonary embolism

You may not qualify if:

• life expectancies of less than 3 months

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria Careggi: lead

Study Sites (4)

Azienda Ospedaliero Universitaria Careggi, Emergency Department

Florence, 50134, Italy

Location

Presidio Ospedaliero Livorno

Livorno, Italy

Location

Azienda ospedaliera universitaria San Giovanni Battista (Molinette)

Torino, Italy

Location

Respiratory Department and Medicine Department, Ramón y Cajal Hospital and Alcalá de Henares University

Madrid, Spain

Location

Related Publications (11)

• Pulido T, Aranda A, Zevallos MA, Bautista E, Martinez-Guerra ML, Santos LE, Sandoval J. Pulmonary embolism as a cause of death in patients with heart disease: an autopsy study. Chest. 2006 May;129(5):1282-7. doi: 10.1378/chest.129.5.1282.

  PMID: 16685020 BACKGROUND

• Burge AJ, Freeman KD, Klapper PJ, Haramati LB. Increased diagnosis of pulmonary embolism without a corresponding decline in mortality during the CT era. Clin Radiol. 2008 Apr;63(4):381-6. doi: 10.1016/j.crad.2007.10.004. Epub 2007 Dec 21.

  PMID: 18325357 BACKGROUND

• Torbicki A, Perrier A, Konstantinides S, Agnelli G, Galie N, Pruszczyk P, Bengel F, Brady AJ, Ferreira D, Janssens U, Klepetko W, Mayer E, Remy-Jardin M, Bassand JP; ESC Committee for Practice Guidelines (CPG). Guidelines on the diagnosis and management of acute pulmonary embolism: the Task Force for the Diagnosis and Management of Acute Pulmonary Embolism of the European Society of Cardiology (ESC). Eur Heart J. 2008 Sep;29(18):2276-315. doi: 10.1093/eurheartj/ehn310. Epub 2008 Aug 30.

  PMID: 18757870 BACKGROUND

• Grifoni S, Olivotto I, Cecchini P, Pieralli F, Camaiti A, Santoro G, Conti A, Agnelli G, Berni G. Short-term clinical outcome of patients with acute pulmonary embolism, normal blood pressure, and echocardiographic right ventricular dysfunction. Circulation. 2000 Jun 20;101(24):2817-22. doi: 10.1161/01.cir.101.24.2817.

  PMID: 10859287 BACKGROUND

• Kucher N, Goldhaber SZ. Cardiac biomarkers for risk stratification of patients with acute pulmonary embolism. Circulation. 2003 Nov 4;108(18):2191-4. doi: 10.1161/01.CIR.0000100687.99687.CE. No abstract available.

  PMID: 14597581 BACKGROUND

• Kline JA, Zeitouni R, Marchick MR, Hernandez-Nino J, Rose GA. Comparison of 8 biomarkers for prediction of right ventricular hypokinesis 6 months after submassive pulmonary embolism. Am Heart J. 2008 Aug;156(2):308-14. doi: 10.1016/j.ahj.2008.03.026. Epub 2008 Jun 18.

  PMID: 18657661 BACKGROUND

• Binder L, Pieske B, Olschewski M, Geibel A, Klostermann B, Reiner C, Konstantinides S. N-terminal pro-brain natriuretic peptide or troponin testing followed by echocardiography for risk stratification of acute pulmonary embolism. Circulation. 2005 Sep 13;112(11):1573-9. doi: 10.1161/CIRCULATIONAHA.105.552216. Epub 2005 Sep 6.

  PMID: 16144990 BACKGROUND

• Shapiro NI, Trzeciak S, Hollander JE, Birkhahn R, Otero R, Osborn TM, Moretti E, Nguyen HB, Gunnerson KJ, Milzman D, Gaieski DF, Goyal M, Cairns CB, Ngo L, Rivers EP. A prospective, multicenter derivation of a biomarker panel to assess risk of organ dysfunction, shock, and death in emergency department patients with suspected sepsis. Crit Care Med. 2009 Jan;37(1):96-104. doi: 10.1097/CCM.0b013e318192fd9d.

  PMID: 19050610 BACKGROUND

• Vanni S, Socci F, Pepe G, Nazerian P, Viviani G, Baioni M, Conti A, Grifoni S. High plasma lactate levels are associated with increased risk of in-hospital mortality in patients with pulmonary embolism. Acad Emerg Med. 2011 Aug;18(8):830-5. doi: 10.1111/j.1553-2712.2011.01128.x.

  PMID: 21843218 BACKGROUND

• Vanni S, Polidori G, Vergara R, Pepe G, Nazerian P, Moroni F, Garbelli E, Daviddi F, Grifoni S. Prognostic value of ECG among patients with acute pulmonary embolism and normal blood pressure. Am J Med. 2009 Mar;122(3):257-64. doi: 10.1016/j.amjmed.2008.08.031.

  PMID: 19272487 BACKGROUND

• Grifoni S, Vanni S, Magazzini S, Olivotto I, Conti A, Zanobetti M, Polidori G, Pieralli F, Peiman N, Becattini C, Agnelli G. Association of persistent right ventricular dysfunction at hospital discharge after acute pulmonary embolism with recurrent thromboembolic events. Arch Intern Med. 2006 Oct 23;166(19):2151-6. doi: 10.1001/archinte.166.19.2151.

  PMID: 17060547 BACKGROUND

MeSH Terms

Conditions

Pulmonary Embolism; Ventricular Dysfunction, Right

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Ventricular Dysfunction; Heart Diseases

Study Officials

• Stefano Grifoni, MD

  Emergency department, Azienda Ospedaliero Universitaria Careggi

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Simone Vanni, MD, PhD

Study Record Dates

• First Submitted: July 23, 2013
• First Posted: July 25, 2013
• Study Start: December 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: February 1, 2014
• Last Updated: February 19, 2014

Record last verified: 2014-02

Locations

ES (1); IT (3)