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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by University Hospital, Linkoeping
Sponsor:
Information provided by (Responsible Party):
Anna Oscarsson, University Hospital, Linkoeping
ClinicalTrials.gov Identifier:
NCT01747187
First received: October 24, 2012
Last updated: December 10, 2012
Last verified: December 2012
  Purpose

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.


Condition
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 University Hospital, Linkoeping:

Primary Outcome Measures:
  • Death [ Time Frame: During ICU stay (max 30 days) ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    The proportion of deaths within 30 and 90 days after ICU admission.

  • Heart failure [ Time Frame: During ICU stay ] [ Designated as safety issue: No ]
    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)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

50 adult patients admitted to ICU for severe sepsis or septic shock.

Criteria

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01747187

Contacts
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

Locations
Sweden
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
Investigators
Principal Investigator: Lina De Geer, MD University Hospital, Linkoeping
  More Information

Publications:

Responsible Party: Anna Oscarsson, MD, PhD, University Hospital, Linkoeping
ClinicalTrials.gov Identifier: NCT01747187     History of Changes
Other Study ID Numbers: Septic Heart
Study First Received: October 24, 2012
Last Updated: December 10, 2012
Health Authority: Sweden: Regional Ethical Review Board

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

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

ClinicalTrials.gov processed this record on November 27, 2014