Reversibility of Diastolic Disfunction in Septic Shock (REPRISS)

Early Reversibility of Diastolic Disfunction as a Prognostic Factor in Septic Shock

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.

Study Overview

• Status: Unknown
• Conditions: Septic Shock; Diastolic Dysfunction
• Intervention / Treatment: Diagnostic test: Echocardiography

• Study Type: Observational
• Enrollment (Anticipated): 350

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain
    • Recruiting
    • Hospital Del Mar
    • Contact: Purificacion Perez
    • Principal Investigator: Irene Dot
  • Barcelona, Spain, 08025
    • Not yet recruiting
    • Hospital de la Santa Creu i Sant Pau
    • Contact: Luis Zapata Fenor, MD PhD; Phone Number: 0034935537255; Email: LZapata@santpau.cat
    • Principal Investigator: Luis Zapata Fenor, MD PhD
  • Barcelona, Spain
    • Recruiting
    • Hospital de la Santa Creu i Sant Pau
    • Contact: Lluis Zapata, MD PhD
  • Barcelona, Spain
    • Recruiting
    • Hospital del Vall d´Hebron
    • Contact: Marina Garcia
  • Tarragona
    • Tortosa, Tarragona, Spain
      • Recruiting
      • Hospital Verge de la Cinta
      • Contact: Ferran Roche-Campo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality at 90 days	Dead at 90 days	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ICU mortality	Dead in ICU	90 days
In hospital mortality	Dead in hospital	90 days
Incidence of myocardial disfunction	According to the criteria specified at groups section	During the first 24 hours of ICU admission
Change in incidence of diastolic dysfunction	Change in incidence of diastolic dysfunction according to the different criteria used.	From first 24 hours of ICU admission until 48h, 72h and 7 days from admission

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Anticipated): January 1, 2019
• Study Completion (Anticipated): April 1, 2019

Study Registration Dates

• First Submitted: June 16, 2017
• First Submitted That Met QC Criteria: June 22, 2017
• First Posted (Actual): June 26, 2017

Study Record Updates

• Last Update Posted (Actual): March 6, 2018
• Last Update Submitted That Met QC Criteria: March 5, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Shock, Septic; Shock
• Other Study ID Numbers: IIBSP-REP-2017-30

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No