NCT05975086

Brief Summary

To assess prevalence of right ventricle dysfunction in critically ill patient. To assess impact of RV dysfunction on short term (ICU stay, hospital stay, or mortality ≤30 days) and long term outcome (\>30 days). To assess the accuracy of different parameters of RV dysfunction.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2023

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 27, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 3, 2023

Completed
27 days until next milestone

Study Start

First participant enrolled

August 30, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

August 3, 2023

Status Verified

July 1, 2023

Enrollment Period

11 months

First QC Date

July 27, 2023

Last Update Submit

July 27, 2023

Conditions

Right Ventricular Dysfunction

Outcome Measures

Primary Outcomes (1)

  • Impact of right ventricle dysfunction in Critically ill patients on short term and long term outcome

    To assess prevalence of right ventricle dysfunction in critically ill patient. To assess impact of RV dysfunction on short term (ICU stay, hospital stay, or mortality ≤30 days) and long term outcome (\>30 days).

    Baseline

Secondary Outcomes (1)

  • Impact of right ventricle dysfunction in Critically ill patients on short term and long term outcome

    Baseline

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

\- Adult patients who admitted to critical care of Internal medicine department after obtaining consent during the period between august 2023 and august 2024.

You may qualify if:

  • Adult patients who admitted to critical care of Internal medicine department after obtaining consent during the period between august 2023 and august 2024.

You may not qualify if:

  • Children below 18 yr.
  • Patients who could not be scanned within 48h after ICU admission.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • Vieillard-Baron A, Millington SJ, Sanfilippo F, Chew M, Diaz-Gomez J, McLean A, Pinsky MR, Pulido J, Mayo P, Fletcher N. A decade of progress in critical care echocardiography: a narrative review. Intensive Care Med. 2019 Jun;45(6):770-788. doi: 10.1007/s00134-019-05604-2. Epub 2019 Mar 25.

    PMID: 30911808BACKGROUND

  • Vieillard-Baron A, Naeije R, Haddad F, Bogaard HJ, Bull TM, Fletcher N, Lahm T, Magder S, Orde S, Schmidt G, Pinsky MR. Diagnostic workup, etiologies and management of acute right ventricle failure : A state-of-the-art paper. Intensive Care Med. 2018 Jun;44(6):774-790. doi: 10.1007/s00134-018-5172-2. Epub 2018 May 9.

    PMID: 29744563BACKGROUND

  • Vieillard-Baron A, Pinsky MR. The difficulty in defining right ventricular failure at the bedside and its clinical significance. Ann Intensive Care. 2021 Aug 5;11(1):122. doi: 10.1186/s13613-021-00912-7. No abstract available.

    PMID: 34351534BACKGROUND

  • Rudski LG, Lai WW, Afilalo J, Hua L, Handschumacher MD, Chandrasekaran K, Solomon SD, Louie EK, Schiller NB. Guidelines for the echocardiographic assessment of the right heart in adults: a report from the American Society of Echocardiography endorsed by the European Association of Echocardiography, a registered branch of the European Society of Cardiology, and the Canadian Society of Echocardiography. J Am Soc Echocardiogr. 2010 Jul;23(7):685-713; quiz 786-8. doi: 10.1016/j.echo.2010.05.010. No abstract available.

    PMID: 20620859BACKGROUND

  • Vos ME, Cox EGM, Schagen MR, Hiemstra B, Wong A, Koeze J, van der Horst ICC, Wiersema R; SICS Study Group. Right ventricular strain measurements in critically ill patients: an observational SICS sub-study. Ann Intensive Care. 2022 Oct 3;12(1):92. doi: 10.1186/s13613-022-01064-y.

    PMID: 36190597BACKGROUND

  • Lang RM, Badano LP, Mor-Avi V, Afilalo J, Armstrong A, Ernande L, Flachskampf FA, Foster E, Goldstein SA, Kuznetsova T, Lancellotti P, Muraru D, Picard MH, Rietzschel ER, Rudski L, Spencer KT, Tsang W, Voigt JU. Recommendations for cardiac chamber quantification by echocardiography in adults: an update from the American Society of Echocardiography and the European Association of Cardiovascular Imaging. Eur Heart J Cardiovasc Imaging. 2015 Mar;16(3):233-70. doi: 10.1093/ehjci/jev014.

    PMID: 25712077BACKGROUND

MeSH Terms

Conditions

Ventricular Dysfunction, Right

Condition Hierarchy (Ancestors)

Ventricular DysfunctionHeart DiseasesCardiovascular Diseases

Central Study Contacts

Mustafa Shaban Abdelsalam

CONTACT

01020216526mustafashaban039@gmail.com

Mohammed Hossam Maghraby

CONTACT

01006261166hossammaghraby@med.aun.edu.eg

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident doctor

Study Record Dates

First Submitted

July 27, 2023

First Posted

August 3, 2023

Study Start

August 30, 2023

Primary Completion

August 1, 2024

Study Completion

September 1, 2024

Last Updated

August 3, 2023

Record last verified: 2023-07