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Reversibility of Diastolic Disfunction in Septic Shock (REPRISS)

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ClinicalTrials.gov Identifier: NCT03198611
Recruitment Status : Recruiting
First Posted : June 26, 2017
Last Update Posted : March 6, 2018
Sponsor:
Collaborator:
Spanish Clinical Research Network - CAIBER
Information provided by (Responsible Party):
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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.


Condition or disease Intervention/treatment
Diastolic Dysfunction Septic Shock Diagnostic Test: Echocardiography

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Study Type : Observational
Estimated Enrollment : 350 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Early Reversibility of Diastolic Disfunction as a Prognostic Factor in Septic Shock
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : January 1, 2019
Estimated Study Completion Date : April 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Group/Cohort Intervention/treatment
Normal function
No systolic dysfunction No diastolic dysfunction No right ventricular dysfunction
Diagnostic Test: Echocardiography
Usual echocardiographic studies in patients suffering septic shock

Left ventricular systolic dysfunction
Left ventricular ejection fraction < 50%
Diagnostic Test: Echocardiography
Usual echocardiographic studies in patients suffering septic shock

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
Usual echocardiographic studies in patients suffering septic shock

Right ventricular dysfunction
Tricuspid annulus plane systolic excursion < 17 cm
Diagnostic Test: Echocardiography
Usual echocardiographic studies in patients suffering septic shock




Primary Outcome Measures :
  1. Mortality at 90 days [ Time Frame: 90 days ]
    Dead at 90 days


Secondary Outcome Measures :
  1. ICU mortality [ Time Frame: 90 days ]
    Dead in ICU

  2. In hospital mortality [ Time Frame: 90 days ]
    Dead in hospital

  3. Incidence of myocardial disfunction [ Time Frame: During the first 24 hours of ICU admission ]
    According to the criteria specified at groups section

  4. Change in incidence of diastolic dysfunction [ Time Frame: From first 24 hours of ICU admission until 48h, 72h and 7 days from admission ]
    Change in incidence of diastolic dysfunction according to the different criteria used.



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients admitted to the ICU with diagnosis of septic shock, and stay longer than 48h
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

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): NCT03198611


Contacts
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Contact: Luis Zapata Fenor, MD PhD 0034935537255 LZapata@santpau.cat

Locations
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Spain
Hospital Verge de la Cinta Recruiting
Tortosa, Tarragona, Spain
Contact: Ferran Roche-Campo         
Hospital de la Santa Creu i Sant Pau Not yet recruiting
Barcelona, Spain, 08025
Contact: Luis Zapata Fenor, MD PhD    0034935537255    LZapata@santpau.cat   
Principal Investigator: Luis Zapata Fenor, MD PhD         
Hospital de la Santa Creu i Sant Pau Recruiting
Barcelona, Spain
Contact: Lluis Zapata, MD PhD         
Hospital del Mar Recruiting
Barcelona, Spain
Contact: Purificacion Perez         
Principal Investigator: Irene Dot         
Hospital del Vall d´Hebron Recruiting
Barcelona, Spain
Contact: Marina Garcia         
Sponsors and Collaborators
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Spanish Clinical Research Network - CAIBER

Publications:
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Responsible Party: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier: NCT03198611     History of Changes
Other Study ID Numbers: IIBSP-REP-2017-30
First Posted: June 26, 2017    Key Record Dates
Last Update Posted: March 6, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Shock, Septic
Shock
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation