We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov Menu

Cardiac Stress in Septic Shock - Biomarkers, Echocardiography and Outcome (Septic Heart)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2012 by Anna Oscarsson, University Hospital, Linkoeping.
Recruitment status was:  Recruiting
ClinicalTrials.gov Identifier:
First Posted: December 11, 2012
Last Update Posted: December 11, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Anna Oscarsson, University Hospital, Linkoeping

Septic shock is a major cause of death in intensive care. Septic shock is often dominated by profound changes in organ functions, of which cardiac failure is one of the most severe. In septic shock, biological markers of cardiac stress are often elevated. It is not known to what extent this indicates structural damage to the heart, or in what way they correlate to echocardiographic signs of heart failure.

Here, cardiac failure in ICU patients with septic shock is studied, using biological markers of cardiac stress, inflammatory parameters and echocardiography.

Investigators hypothesize that biomarkers of cardiac stress correlate with echocardiographic signs of heart failure, and that they can predict an increased risk of death.

Septic Shock Left Ventricular Systolic Dysfunction Left Ventricular Diastolic Dysfunction

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cardiac Stress in Septic Shock - Biomarkers, Echocardiography and Outcome.

Resource links provided by NLM:

Further study details as provided by Anna Oscarsson, University Hospital, Linkoeping:

Primary Outcome Measures:
  • Death [ Time Frame: During ICU stay (max 30 days) ]
    The proportion of deaths among patients in septic shock during ICU stay, with a maximum of 30 days.

Secondary Outcome Measures:
  • Death [ Time Frame: Within 30 and 90 days ]
    The proportion of deaths within 30 and 90 days after ICU admission.

  • Heart failure [ Time Frame: During ICU stay ]
    The proportion of patients showing signs of heart failure during ICU stay.

Estimated Enrollment: 50
Study Start Date: October 2012
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Septic shock

Detailed Description:

Sepsis and septic shock are major health concerns worldwide. Sepsis is the consequence of inflammatory processes and humoral and cellular reactions to severe infection. Its clinical presentation is variable, with a continuum from a systemic response to infection to fulminant disease refractory to resuscitation and with multiple organ failure. Septic shock is the most severe form of sepsis and the leading cause of death in intensive care patients with a high mortality despite modern resuscitation and treatment.

Septic shock is dominated clinically by circulatory changes presenting with profound vasodilatation and hypotension. Cardiac output values are often seemingly normal, or even enhanced, when compared with the physiological range. However, relative to the vasodilatation, cardiac output is often not adequately enhanced. Thus, the degree of myocardial depression in sepsis is often underestimated by the clinician, albeit a factor that markedly increases mortality.

Septic cardiomyopathy typically engages both ventricles globally, and involves diminished cardiac response to volume and circulating catecholamines. It is not primarily hypoxic, but rather has a multifactorial origin. In survivors, it is typically reversible, but long-term consequences are not known.

Cardiac biomarkers, i.e. troponins and natriuretic peptides, are all associated with worse outcome in septic shock. Cardiac troponins are frequently elevated and correlate to the duration of hypotension and the intensity of vasopressor support. Elevated natriuretic peptides predict adverse outcome, and values are often markedly elevated even in seemingly normal echocardiographic findings. It is not clear whether this indicates structural myocardial damage, or rather demonstrate a global septic membrane leakage. Thus, with the complexity of sepsis, combinations of cardiac biomarkers and markers of global inflammation may provide a more robust tool for stratification and prognostication and for evaluation of septic organ dysfunction. In clinical cardiology, combinations of biomarkers of myocardial stress are used for stratification and prognostication of myocardial failure, but the role of such multimarker panels in septic cardiomyopathy has not been studied.

Echocardiography is used clinically, and has been the focus of several studies, to characterize septic cardiomyopathy. Echocardiographic signs of systolic dysfunction has been the main focus of previous investigations, and the systolic component is the focus of modern guidelines of clinical management in septic cardiomyopathy. The role of diastolic dysfunction is gaining interest, with data suggesting higher mortality in patients with diastolic dysfunction than in those with systolic dysfunction. To date, the correlation of echocardiographic signs of systolic or diastolic dysfunction myocardial stress biomarker panels, and the dynamics of any correlation, has not been studied.

The hypothesis of this study is that biological markers of cardiac stress correlate with echocardiographic signs of cardiac failure, that they can predict outcome, and that they correlate to conventional methods of outcome prediction.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
50 adult patients admitted to ICU for severe sepsis or septic shock.

Inclusion Criteria:

  • Adult patients admitted to ICU for severe sepsis or septic shock

Exclusion Criteria:

  • Expected ICU stay <24hrs
  • Patients in which mental inabilities or language barriers impair the possibility of informed consent.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01747187

Contact: Lina De Geer, MD +46 10 103 00 00 lina.degeer@lio.se
Contact: Anna Oscarsson, MD, PhD +46 10 103 00 00 anna.oscarsson@lio.se

Dept of Intensive Care, University Hospital, Linkoeping Recruiting
Linkoeping, Sweden, 58185
Contact: Lina De Geer, MD    +46 10 103 00 00    lina.degeer@lio.se   
Contact: Anna Oscarsson, MD, PhD    +46 10 103 00 00    anna.oscarsson@lio.se   
Sponsors and Collaborators
University Hospital, Linkoeping
Principal Investigator: Lina De Geer, MD University Hospital, Linkoeping
  More Information

Gullo A, Bianco N, Berlot G. Management of severe sepsis and septic shock: challenges and recommendations. Crit Care Clin. 2006 Jul;22(3):489-501, ix. Review.
Lever A, Mackenzie I. Sepsis: definition, epidemiology, and diagnosis. BMJ. 2007 Oct 27;335(7625):879-83. Review.
Russell JA, Boyd J, Nakada T, Thair S, Walley KR. Molecular mechanisms of sepsis. Contrib Microbiol. 2011;17:48-85. doi: 10.1159/000324009. Epub 2011 Jun 9. Review.
Flynn A, Chokkalingam Mani B, Mather PJ. Sepsis-induced cardiomyopathy: a review of pathophysiologic mechanisms. Heart Fail Rev. 2010 Nov;15(6):605-11. doi: 10.1007/s10741-010-9176-4. Review.
Sturgess DJ, Marwick TH, Joyce C, Jenkins C, Jones M, Masci P, Stewart D, Venkatesh B. Prediction of hospital outcome in septic shock: a prospective comparison of tissue Doppler and cardiac biomarkers. Crit Care. 2010;14(2):R44. doi: 10.1186/cc8931. Epub 2010 Mar 24.
ver Elst KM, Spapen HD, Nguyen DN, Garbar C, Huyghens LP, Gorus FK. Cardiac troponins I and T are biological markers of left ventricular dysfunction in septic shock. Clin Chem. 2000 May;46(5):650-7.
Rivers EP, McCord J, Otero R, Jacobsen G, Loomba M. Clinical utility of B-type natriuretic peptide in early severe sepsis and septic shock. J Intensive Care Med. 2007 Nov-Dec;22(6):363-73.
Pierrakos C, Vincent JL. Sepsis biomarkers: a review. Crit Care. 2010;14(1):R15. doi: 10.1186/cc8872. Epub 2010 Feb 9. Review.
Landesberg G, Gilon D, Meroz Y, Georgieva M, Levin PD, Goodman S, Avidan A, Beeri R, Weissman C, Jaffe AS, Sprung CL. Diastolic dysfunction and mortality in severe sepsis and septic shock. Eur Heart J. 2012 Apr;33(7):895-903. doi: 10.1093/eurheartj/ehr351. Epub 2011 Sep 11.
Salem R, Vallee F, Rusca M, Mebazaa A. Hemodynamic monitoring by echocardiography in the ICU: the role of the new echo techniques. Curr Opin Crit Care. 2008 Oct;14(5):561-8. doi: 10.1097/MCC.0b013e32830e6d81. Review.
Rudiger A, Singer M. Mechanisms of sepsis-induced cardiac dysfunction. Crit Care Med. 2007 Jun;35(6):1599-608. Review.
Levy MM, Dellinger RP, Townsend SR, Linde-Zwirble WT, Marshall JC, Bion J, Schorr C, Artigas A, Ramsay G, Beale R, Parker MM, Gerlach H, Reinhart K, Silva E, Harvey M, Regan S, Angus DC; Surviving Sepsis Campaign. The Surviving Sepsis Campaign: results of an international guideline-based performance improvement program targeting severe sepsis. Crit Care Med. 2010 Feb;38(2):367-74. doi: 10.1097/CCM.0b013e3181cb0cdc.

Responsible Party: Anna Oscarsson, MD, PhD, University Hospital, Linkoeping
ClinicalTrials.gov Identifier: NCT01747187     History of Changes
Other Study ID Numbers: Septic Heart
First Submitted: October 24, 2012
First Posted: December 11, 2012
Last Update Posted: December 11, 2012
Last Verified: December 2012

Keywords provided by Anna Oscarsson, University Hospital, Linkoeping:
Septic shock
Critical care
cardiac failure

Additional relevant MeSH terms:
Shock, Septic
Ventricular Dysfunction, Left
Pathologic Processes
Systemic Inflammatory Response Syndrome
Ventricular Dysfunction
Heart Diseases
Cardiovascular Diseases

To Top