Diastolic dYsfunctioN AssessMent in critICally Ill Patients

NCT04584203 | Unknown

• 1 other identifier: DYNAMIC
• Study Type: observational
• Target: 297
• Locations: 1 country
• Sites: 8

Brief Summary

The role of the left ventricular diastolic function (LVDD) in the weaning failure from mechanical ventilation in unclear. Specifically, is unclear whether the outcome of the weaning process could be affected by a pre-existing LVDD (before ICU admission), or by the worsening of a chronic pattern, or by a de-novo LVDD presentation.

Conditions

Critical Illness; Diastolic Dysfunction; Diastolic Heart Failure; Weaning Failure; Mechanical Ventilation Complication

Outcome Measures

Primary Outcomes (2)

• Spontaneous breathing trial failure

  Patients admitted with LVDD

  6 hour after Spontaneous breathing trial end

• Spontaneous breathing trial failure

  Patients worsening a pre-existing LVDD or developing a LVDD during the ICU stay.

  6 hour after Spontaneous breathing trial end

Secondary Outcomes (3)

• Prevalence of LVDD in critically ill patients

  up to 3 weeks

• To assess the degree of the LVDD in critically ill patients

  up to 3 weeks

• To correlate LVDD with clinical outcomes

  up to 3 weeks

Interventions

Bedside Echocardiography DIAGNOSTIC_TEST

All the intensivists performing the TTE in the involved centers fulfill the criteria of the American Society of Echocardiography and of the European Society of Intensive Care. Medicine to be considered as experts in critical care echocardiography. Each center performs the TTE evaluation by means of the ultrasound device available in the unit equipped with the tissue Doppler imaging program and a phased array transducer of 2.5 MHz and doppler signals is recorded along with the electrocardiogram. For the purpose of this study, the following TTE parameters are recorded from the apical 4-chamber view during each set of measurements:

Spontaneuos breathing trial PROCEDURE

The Spontaneous Breathing Trial will be performed accordingly to the clinical practice of the involved centers (a total support - including positive end-expiratory pressure plus pressure support equal or lower to 8 cmH20)

Bedside Echocardiography_1 DIAGNOSTIC_TEST

Echocardiography performed within 24h from patient's admission - not optional

Also known as: Baseline Echo_1

Bedside Echocardiography_2 DIAGNOSTIC_TEST

Echocardiography performed within 12h from patient's spontaneous breathing trial - not optional

Also known as: Echo_2

Bedside Echocardiography_3 DIAGNOSTIC_TEST

Echocardiography performed at 60 +/- 12h from patient's admission - optional

Also known as: Echo_3

Bedside Echocardiography_4 DIAGNOSTIC_TEST

Echocardiography performed 24h after patient's estubation - optional

Also known as: Echo_4

Eligibility Criteria

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

Study Population

Critically ill patients admitted to General ICU

You may qualify if:

• Expected to be ventilated for \>48 hours
• Age \> 50

You may not qualify if:

• Atrial fibrillation (at the admission or during ICU stay);
• Neuromuscular disorders
• . Severe neurological events (traumatic or not) with GCS \< 8 at admission
• Home ventilation prior to admission;
• Palliative intubation;
• Intubation for an indication to tracheostomy;
• Poor acoustic window (after the first assessment);
• Severe mitral and/or aortic valve stenosis or regurgitation.

Sponsors & Collaborators

• Humanitas Clinical and Research Center: lead

Study Sites (8)

Humanitas Research Hospital

Rozzano, Milano, 20089, Italy

RECRUITING

Ospedale Ss. Trinità

Borgomanero, Novara, 28100, Italy

NOT YET RECRUITING

Careggi University Hospital

Florence, Tuscany, 50134, Italy

NOT YET RECRUITING

"Policlinico-San Marco"

Catania, Italy

NOT YET RECRUITING

Azienda Ospedaliera di Perugia

Perugia, Italy

NOT YET RECRUITING

Grande Ospedale Metropolitano

Reggio Calabria, Italy

NOT YET RECRUITING

Policlinico Universitario A. Gemelli

Roma, Italy

NOT YET RECRUITING

Azienda Sanitaria Universitaria Integrata di Udine

Udine, Italy

NOT YET RECRUITING

Related Publications (5)

• 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, Popescu BA, Waggoner AD. 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. J Am Soc Echocardiogr. 2016 Apr;29(4):277-314. doi: 10.1016/j.echo.2016.01.011. No abstract available.

  PMID: 27037982 BACKGROUND

• Schmidt GA, Girard TD, Kress JP, Morris PE, Ouellette DR, Alhazzani W, Burns SM, Epstein SK, Esteban A, Fan E, Ferrer M, Fraser GL, Gong MN, Hough CL, Mehta S, Nanchal R, Patel S, Pawlik AJ, Schweickert WD, Sessler CN, Strom T, Wilson KC, Truwit JD. Liberation From Mechanical Ventilation in Critically Ill Adults: Executive Summary of an Official American College of Chest Physicians/American Thoracic Society Clinical Practice Guideline. Chest. 2017 Jan;151(1):160-165. doi: 10.1016/j.chest.2016.10.037. Epub 2016 Nov 3.

  PMID: 27818329 BACKGROUND

• Subira C, Hernandez G, Vazquez A, Rodriguez-Garcia R, Gonzalez-Castro A, Garcia C, Rubio O, Ventura L, Lopez A, de la Torre MC, Keough E, Arauzo V, Hermosa C, Sanchez C, Tizon A, Tenza E, Laborda C, Cabanes S, Lacueva V, Del Mar Fernandez M, Arnau A, Fernandez R. Effect of Pressure Support vs T-Piece Ventilation Strategies During Spontaneous Breathing Trials on Successful Extubation Among Patients Receiving Mechanical Ventilation: A Randomized Clinical Trial. JAMA. 2019 Jun 11;321(22):2175-2182. doi: 10.1001/jama.2019.7234.

  PMID: 31184740 BACKGROUND

• de Meirelles Almeida CA, Nedel WL, Morais VD, Boniatti MM, de Almeida-Filho OC. Diastolic dysfunction as a predictor of weaning failure: A systematic review and meta-analysis. J Crit Care. 2016 Aug;34:135-41. doi: 10.1016/j.jcrc.2016.03.007. Epub 2016 Mar 16.

  PMID: 27067288 BACKGROUND

• Vignon P. Ventricular diastolic abnormalities in the critically ill. Curr Opin Crit Care. 2013 Jun;19(3):242-9. doi: 10.1097/MCC.0b013e32836091c3.

  PMID: 23624639 BACKGROUND

MeSH Terms

Conditions

Critical Illness; Heart Failure, Diastolic

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Failure; Heart Diseases; Cardiovascular Diseases

Study Officials

• Antonio Messina, PhD

  Humanitas Mirasole SpA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonio Messina, PhD

CONTACT

+390282241; antonio.messina@humanitas.it

Study Design

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

Study Record Dates

• First Submitted: July 24, 2020
• First Posted: October 12, 2020
• Study Start: June 1, 2021
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: January 3, 2022

Record last verified: 2021-12

Locations

IT (8)