Right Ventricle Dysfunction in Critically Ill Patients

Right Ventricular Dysfunction Clinical Trial

Official title:

Right Ventricle Dysfunction in Critically Ill Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05975086
• Other study ID #: RVD
• Status: Not yet recruiting
• Start date: August 30, 2023
• Est. completion date: September 1, 2024

Study information

• Verified date: July 2023
• Source: Assiut University
• Contact: Mustafa Shaban Abdelsalam
• Phone: 01020216526
• Email: mustafashaban039[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

1. Inclusion criteria:

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

2. Exclusion criteria:

1. Children below 18 yr.

2. Patients who could not be scanned within 48h after ICU admission.

3. Sample Size Calculation:

200 patients 2.4.4 Study tools (in detail, e.g., lab methods, instruments, steps, chemicals, ):

Beside history and clinical examination , The following data will be obtained:

Demographic and historical data: the patient age, sex, history of hypertension, chronic obstructive pulmonary disease, IHD, cause of critical care unit admission and indication of mechanical ventilation( PEEP).

Clinical examination data: pulse, blood pressure, respiratory rate, temperature , BMI, and thorough chest, cardiac examination data will be obtained.

Volume state of the patient: CVP measurement, input and output fluid chart. APACHE IV score, Use of vasopressors, Use of sedatives. Investigation : Arterial blood gas analysis, pulse oxygen saturation, CBC, and renal function test and electrolytes, serum lactate and troponin.

12 lead ECG for RV strain patterns.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: September 1, 2024
• Est. primary completion date: August 1, 2024
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

1. Children below 18 yr.

2. Patients who could not be scanned within 48h after ICU admission.

Related Conditions & MeSH terms

• Right Ventricular Dysfunction
• Ventricular Dysfunction
• Ventricular Dysfunction, Right

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (6)

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. Erratum In: Eur Heart J Cardiovasc Imaging. 2016 Apr;17(4):412. Eur Heart J Cardiovasc Imaging. 2016 Sep;17 (9):969. — View Citation

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. — View Citation

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. Erratum In: Intensive Care Med. 2019 Apr 15;: — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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