Reversibility of Diastolic Disfunction in Septic Shock

NCT03198611 | Unknown

• 1 other identifier: IIBSP-REP-2017-30
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 5

Brief Summary

Objectives: To study the prognostic value of the evolution of diastolic function according to fluid balance in patients admitted to the ICU with a diagnosis of septic shock, in terms of mortality (ICU and hospital) and mortality at 90 days. 2.4. Secondary objectives: A) Incidence and reversibility of myocardial dysfunction (left ventricular systolic and diastolic) in septic shock. B) Incidence and reversibility of diastolic dysfunction according to the echocardiographic criterion used. C) Incidence and reversibility of right ventricular systolic dysfunction.

Conditions

Diastolic Dysfunction; Septic Shock

Outcome Measures

Primary Outcomes (1)

• Mortality at 90 days

  Dead at 90 days

  90 days

Secondary Outcomes (4)

• ICU mortality

  90 days

• In hospital mortality

  90 days

• Incidence of myocardial disfunction

  During the first 24 hours of ICU admission

• Change in incidence of diastolic dysfunction

  From first 24 hours of ICU admission until 48h, 72h and 7 days from admission

Study Arms (4)

Normal function

No systolic dysfunction No diastolic dysfunction No right ventricular dysfunction

Diagnostic Test: Echocardiography

Left ventricular systolic dysfunction

Left ventricular ejection fraction \< 50%

Diagnostic Test: Echocardiography

Left ventricular diastolic dysfunction

Classification according to: * Mitral lateral annulus e' in tissue Doppler \< 10 cm/s * American society of echocardiography (ASE) criteria 2009 * ASE criteria 2016

Diagnostic Test: Echocardiography

Right ventricular dysfunction

Tricuspid annulus plane systolic excursion \< 17 cm

Diagnostic Test: Echocardiography

Interventions

Echocardiography DIAGNOSTIC_TEST

Usual echocardiographic studies in patients suffering septic shock

Left ventricular diastolic dysfunction; Left ventricular systolic dysfunction; Normal function; Right ventricular dysfunction

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to the ICU with diagnosis of septic shock, and stay longer than 48h

You may qualify if:

• Patients admitted to the ICU with diagnosis of septic shock, and stay longer than 48h

You may not qualify if:

• No echocardiographic window
• Fatal prognosis with do not resuscitate orders at admission
• Previous history of Ischemic cardiomyopathy
• Valvular prosthesis
• Advanced degree of valvular disorder
• Advanced degree of pericardial effusion

Sponsors & Collaborators

• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: lead
• Spanish Clinical Research Network - SCReN: collaborator

Study Sites (5)

Hospital Verge de la Cinta

Tortosa, Tarragona, Spain

RECRUITING

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

NOT YET RECRUITING

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

RECRUITING

Hospital del Mar

Barcelona, Spain

RECRUITING

Hospital del Vall d´Hebron

Barcelona, Spain

RECRUITING

Related Publications (3)

• Suarez JC, Lopez P, Mancebo J, Zapata L. Diastolic dysfunction in the critically ill patient. Response from the authors. Med Intensiva. 2017 Apr;41(3):198. doi: 10.1016/j.medin.2016.12.008. Epub 2017 Mar 3. No abstract available. English, Spanish.

  PMID: 28262372 BACKGROUND

• Mahjoub Y, Benoit-Fallet H, Airapetian N, Lorne E, Levrard M, Seydi AA, Amennouche N, Slama M, Dupont H. Improvement of left ventricular relaxation as assessed by tissue Doppler imaging in fluid-responsive critically ill septic patients. Intensive Care Med. 2012 Sep;38(9):1461-70. doi: 10.1007/s00134-012-2618-9. Epub 2012 Jun 21.

  PMID: 22717694 BACKGROUND

• Nagueh SF, Smiseth OA, Appleton CP, Byrd BF 3rd, Dokainish H, Edvardsen T, Flachskampf FA, Gillebert TC, Klein AL, Lancellotti P, Marino P, Oh JK, Alexandru Popescu B, Waggoner AD; Houston, Texas; Oslo, Norway; Phoenix, Arizona; Nashville, Tennessee; Hamilton, Ontario, Canada; Uppsala, Sweden; Ghent and Liege, Belgium; Cleveland, Ohio; Novara, Italy; Rochester, Minnesota; Bucharest, Romania; and St. Louis, Missouri. Recommendations for the Evaluation of Left Ventricular Diastolic Function by Echocardiography: An Update from the American Society of Echocardiography and the European Association of Cardiovascular Imaging. Eur Heart J Cardiovasc Imaging. 2016 Dec;17(12):1321-1360. doi: 10.1093/ehjci/jew082. Epub 2016 Jul 15. No abstract available.

  PMID: 27422899 BACKGROUND

MeSH Terms

Conditions

Shock, Septic

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Central Study Contacts

Luis Zapata Fenor, MD PhD

CONTACT

0034935537255; LZapata@santpau.cat

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2017
• First Posted: June 26, 2017
• Study Start: March 1, 2018
• Primary Completion: January 1, 2019
• Study Completion: April 1, 2019
• Last Updated: March 6, 2018

Record last verified: 2018-03

Locations

ES (5)