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Not yet recruitingNCT05975086Updated Aug 3, 2023

Right Ventricle Dysfunction in Critically Ill Patients

An observational study in Right Ventricular Dysfunction, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-08-03.

Sponsored by Assiut University · Observational

From the registry’s dates

  • Primary completion was expected by Aug 2024, 2 years 3 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Right Ventricular Dysfunction
03

In context

Ventricular Dysfunction, Right

90 studies on the registry are indexed under Ventricular Dysfunction, Right; 28 are open to participants now.

This study's planned enrollment of 200 is above the median of 100 across 51 observational studies indexed under Ventricular Dysfunction, Right.

Browse Ventricular Dysfunction, Right studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Sampling method
Non-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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  1. Children below 18 yr.
  2. Patients who could not be scanned within 48h after ICU admission.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No
06

What researchers measure

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).

    Time frame: Baseline

Secondary 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).

    Time frame: Baseline

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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 Jun;45(6):911. doi: 10.1007/s00134-019-05616-y. PubMed 30911808 ↗
  • 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. PubMed 29744563 ↗
  • 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. PubMed 34351534 ↗
  • 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. PubMed 20620859 ↗
  • 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. PubMed 36190597 ↗
  • 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. doi: 10.1093/ehjci/jew041. Eur Heart J Cardiovasc Imaging. 2016 Sep;17(9):969. doi: 10.1093/ehjci/jew124. PubMed 25712077 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Aug 2023; primary completion for Aug 2024, 11 months later.

Of 25 observational studies under Ventricular Dysfunction, Right, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 26. This study's planned 11 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 27, 2023
First posted
Aug 3, 2023
StartEst.
Aug 30, 2023
Primary completionEst.
Aug 1, 2024
CompletionEst.
Sep 1, 2024
Last update
Aug 3, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 3, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05975086
Lead sponsor
Assiut University
Responsible party
Mustafa Shaban Abdelsalam Thabet (Resident doctor, Assiut University) — Principal investigator
First posted
Aug 3, 2023
Start date
Aug 30, 2023 (estimated)
Primary completion
Aug 1, 2024 (estimated)
Completion
Sep 1, 2024 (estimated)
Last update
Aug 3, 2023

Study contacts

Mustafa Shaban Abdelsalam
Contact
mustafashaban039@gmail.com
01020216526
Mohammed Hossam Maghraby
Contact
hossammaghraby@med.aun.edu.eg
01006261166

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

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