NCT01747187

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

October 24, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 11, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

December 11, 2012

Status Verified

December 1, 2012

Enrollment Period

2 years

First QC Date

October 24, 2012

Last Update Submit

December 10, 2012

Conditions

Septic ShockLeft Ventricular Systolic DysfunctionLeft Ventricular Diastolic Dysfunction

Keywords

Septic shockCritical carecardiac failure

Outcome Measures

Primary Outcomes (1)

  • Death

    The proportion of deaths among patients in septic shock during ICU stay, with a maximum of 30 days.

    During ICU stay (max 30 days)

Secondary Outcomes (2)

  • Death

    Within 30 and 90 days

  • Heart failure

    During ICU stay

Study Arms (1)

Septic shock

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Expected ICU stay \<24hrs
  • Patients in which mental inabilities or language barriers impair the possibility of informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept of Intensive Care, University Hospital, Linkoeping

Linköping, 58185, Sweden

RECRUITING

Related Publications (13)

  • 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. doi: 10.1016/j.ccc.2006.03.006.

    PMID: 16893735BACKGROUND

  • Lever A, Mackenzie I. Sepsis: definition, epidemiology, and diagnosis. BMJ. 2007 Oct 27;335(7625):879-83. doi: 10.1136/bmj.39346.495880.AE. No abstract available.

    PMID: 17962288BACKGROUND

  • 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.

    PMID: 21659747BACKGROUND

  • 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.

    PMID: 20571889BACKGROUND

  • 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.

    PMID: 20331902BACKGROUND

  • 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.

    PMID: 10794747BACKGROUND

  • 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. doi: 10.1177/0885066607307523.

    PMID: 18051697BACKGROUND

  • Pierrakos C, Vincent JL. Sepsis biomarkers: a review. Crit Care. 2010;14(1):R15. doi: 10.1186/cc8872. Epub 2010 Feb 9.

    PMID: 20144219BACKGROUND

  • 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.

    PMID: 21911341BACKGROUND

  • 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.

    PMID: 18787450BACKGROUND

  • Rudiger A, Singer M. Mechanisms of sepsis-induced cardiac dysfunction. Crit Care Med. 2007 Jun;35(6):1599-608. doi: 10.1097/01.CCM.0000266683.64081.02.

    PMID: 17452940BACKGROUND

  • 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.

    PMID: 20035219BACKGROUND

  • Blixt PJ, Nguyen M, Cholley B, Hammarskjold F, Toiron A, Bouhemad B, Lee S, De Geer L, Andersson H, Aneq MA, Engvall J, Chew MS. Association between left ventricular systolic function parameters and myocardial injury, organ failure and mortality in patients with septic shock. Ann Intensive Care. 2024 Jan 18;14(1):12. doi: 10.1186/s13613-023-01235-5.

    PMID: 38236316DERIVED

MeSH Terms

Conditions

Shock, SepticVentricular Dysfunction, LeftHeart Failure

Condition Hierarchy (Ancestors)

SepsisInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShockVentricular DysfunctionHeart DiseasesCardiovascular Diseases

Study Officials

  • Lina De Geer, MD

    University Hospital, Linkoeping

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lina De Geer, MD

CONTACT

+46 10 103 00 00lina.degeer@lio.se

Anna Oscarsson, MD, PhD

CONTACT

+46 10 103 00 00anna.oscarsson@lio.se

Study Design

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

Study Record Dates

First Submitted

October 24, 2012

First Posted

December 11, 2012

Study Start

October 1, 2012

Primary Completion

October 1, 2014

Study Completion

April 1, 2015

Last Updated

December 11, 2012

Record last verified: 2012-12

Locations

SE(1)