Right Ventricular DysfunctionNCT05975086
Right Ventricle Dysfunction in Critically Ill Patients
An observational study of Right Ventricular Dysfunction, run by Assiut University.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Right Ventricular Dysfunction
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 30 Aug 2023to 1 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- Adult patients who admitted to critical care of Internal medicine department after obtaining consent during the period between august 2023 and august 2024.
Who cannot join
- Children below 18 yr.
- Patients who could not be scanned within 48h after ICU admission.
Trial locations and contacts
No sites are listed yet.
About this study
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
- 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:
- Children below 18 yr.
- Patients who could not be scanned within 48h after ICU admission.
- 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.
- Conditions
- Right Ventricular Dysfunction
- Medical subject headings
- Ventricular Dysfunction, Right
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2023
- Study start30 Aug 2023 (estimated)
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Right Ventricular DysfunctionStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Shaban Abdelsalam Thabet, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05975086
- Sponsor's protocol ID
- RVD
- Status last verified
- Jul 2023
- First submitted
- 27 Jul 2023
- Last updated
- 3 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 30911808Vieillard-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 29744563Vieillard-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 34351534Rudski 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 20620859Vos 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 36190597Lang 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.
PubMed 25712077
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Right Ventricle Dysfunction in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT05975086
- Acronym / sponsor ID
- RVD
- Conditions
- Right Ventricular Dysfunction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 30 Aug 2023 (estimated)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 3 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- 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:
- Children below 18 yr.
- Patients who could not be scanned within 48h after ICU admission.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Adult patients who admitted to critical care of Internal medicine department after obtaining consent during the period between august 2023 and august 2024.
Key exclusion criteria (2 listed)
- Children below 18 yr.
- Patients who could not be scanned within 48h after ICU admission.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Impact of right ventricle dysfunction in Critically ill patients on short term and long term outcome
Time frame: Baseline
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).
1 secondary outcome
Impact of right ventricle dysfunction in Critically ill patients on short term and long term outcome
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2023.
- Background: PubMed 30911808Vieillard-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.
- Background: PubMed 29744563Vieillard-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.
- Background: PubMed 34351534Vieillard-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.
- Background: PubMed 20620859Rudski 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.
- Background: PubMed 36190597Vos 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.
- Background: PubMed 25712077Lang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Right Ventricular Dysfunction, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mustafa Shaban Abdelsalam (01020216526, mustafashaban039@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of right ventricle dysfunction in Critically ill patients on short term and long term outcome (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05975086, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2023.