Reversibility of Diastolic Disfunction in Septic Shock

Septic Shock Clinical Trial

— REPRISS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03198611
• Other study ID #: IIBSP-REP-2017-30
• Status: Recruiting
• Phase: N/A
• First received: June 16, 2017
• Last updated: March 5, 2018
• Start date: March 1, 2018
• Est. completion date: April 1, 2019

Study information

• Verified date: March 2018
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: Luis Zapata Fenor, MD PhD
• Phone: 0034935537255
• Email: LZapata[@]santpau.cat
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: April 1, 2019
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Diastolic Dysfunction
• Septic Shock
• Shock
• Shock, Septic

Intervention

Diagnostic Test:
• Echocardiography
Usual echocardiographic studies in patients suffering septic shock

Locations

Country	Name	City	State
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Hospital del Vall d´Hebron	Barcelona
Spain	Hospital Verge de la Cinta	Tortosa	Tarragona

Sponsors (2)

Lead Sponsor	Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau	SCReN: Spanish Clinical Research Network ISCIII

Country where clinical trial is conducted

Spain, 

References & Publications (3)

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. — View Citation

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 Liège, 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. Epub 2016 Jul 15. Review. — View Citation

Suárez JC, López 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. English, Spanish. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality at 90 days	Dead at 90 days	90 days
Secondary	ICU mortality	Dead in ICU	90 days
Secondary	In hospital mortality	Dead in hospital	90 days
Secondary	Incidence of myocardial disfunction	According to the criteria specified at groups section	During the first 24 hours of ICU admission
Secondary	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