Reversibility of Diastolic Disfunction in Septic Shock

NCT ID: NCT03198611

Last Updated: 2018-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

350 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-01

Study Completion Date

2019-04-01

Brief Summary

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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.

Detailed Description

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Conditions

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Diastolic Dysfunction Septic Shock

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Normal function

No systolic dysfunction No diastolic dysfunction No right ventricular dysfunction

Echocardiography

Intervention Type DIAGNOSTIC_TEST

Usual echocardiographic studies in patients suffering septic shock

Left ventricular systolic dysfunction

Left ventricular ejection fraction \< 50%

Echocardiography

Intervention Type DIAGNOSTIC_TEST

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

Echocardiography

Intervention Type DIAGNOSTIC_TEST

Usual echocardiographic studies in patients suffering septic shock

Right ventricular dysfunction

Tricuspid annulus plane systolic excursion \< 17 cm

Echocardiography

Intervention Type DIAGNOSTIC_TEST

Usual echocardiographic studies in patients suffering septic shock

Interventions

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Echocardiography

Usual echocardiographic studies in patients suffering septic shock

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Spanish Clinical Research Network - SCReN

NETWORK

Sponsor Role collaborator

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital Verge de la Cinta

Tortosa, Tarragona, Spain

Site Status RECRUITING

Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

Site Status NOT_YET_RECRUITING

Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

Site Status RECRUITING

Hospital del Mar

Barcelona, , Spain

Site Status RECRUITING

Hospital del Vall d´Hebron

Barcelona, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Luis Zapata Fenor, MD PhD

Role: CONTACT

0034935537255

Facility Contacts

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Ferran Roche-Campo

Role: primary

Luis Zapata Fenor, MD PhD

Role: primary

0034935537255

Lluis Zapata, MD PhD

Role: primary

Purificacion Perez

Role: primary

Marina Garcia

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 28262372 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22717694 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27422899 (View on PubMed)

Other Identifiers

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IIBSP-REP-2017-30

Identifier Type: -

Identifier Source: org_study_id

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