Septic ShockSepticshockNCT05193682
Right Ventricular Dysfunction in Septic Shock Patients in ICU
An observational study of Septic Shock, run by Shimaa Hammad Ahmed.
Trial summary
Assesment of right ventricular dysfunction in septic shock patients in intensive care unit. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Septic Shock
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Oct 2022to Mar 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Septic shock patients
Who may be able to join
- Patients diagnosed with septic shock.
- Patients will be evaluated within 24 h after diagnosis.
Who cannot join
- Patients diagnosed more than 24 hours.
- Patients with associated ischemic heart failure .
About this study
Official title: Evaluation Of Right Ventricular Function In Septic Shock Patients In Intensive Care Unit.
Assesment of right ventricular dysfunction in septic shock patients in intensive care unit.
Read the detailed description
Over the last decade, a few studies have highlighted the crucial role of right ventricular (RV) function in hemodynamic and respiratory diseases in critical care 1,2. However, RV failure is difficult to define in the critical care setting. A recent consensual definition proposed by different groups of experts characterizes RV failure as the association of a significant RV dilatation associated with systemic congestion 3-5. This definition is mainly physiologically based, not strictly validated, and the experts did not propose any threshold for RV size or congestion using critical care echocardiography (CCE) and central venous pressure (CVP), respectively.
Fluid management in septic shock is crucial for prognosis, as fluid overload and high CVP are associated with a worse outcome 6. Septic shock is expected to impair RV function through the development of septic cardiomyopathy, but the incidence of RV failure is unknown.
- Conditions
- Septic Shock
- Medical subject headings
- Shock, Septic
What is being measured
The primary outcome is the main question the study is designed to answer.
Right ventricular dysfunction in septic shock patients in intensive care unit
Fluid management in septic shock is crucial for prognosis, as fluid overload and high CVP are associated with a worse outcome 6. Septic shock is expected to impair RV function through the development of septic cardiomyopathy, but the incidence of RV failure is unknown.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2022
- Study startOct 2022 (estimated)
- Primary completionMar 2023 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shimaa Hammad Ahmed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shimaa Hammad Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05193682
- Sponsor's protocol ID
- Septic shock in ICU patients.
- Acronym
- Septicshock
- Status last verified
- Oct 2022
- First submitted
- 30 Dec 2021
- Last updated
- 25 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of Right Ventricular Function In Septic Shock Patients In Intensive Care Unit.
- ClinicalTrials.gov ID
- NCT05193682
- Acronym / sponsor ID
- Septicshock / Septic shock in ICU patients.
- Conditions
- Septic Shock
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Shimaa Hammad AhmedUniversity, hospital or other
- Study start
- Oct 2022 (estimated)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 18 Jan 2022 (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.
Assesment of right ventricular dysfunction in septic shock patients in intensive care unit.
Detailed description
Over the last decade, a few studies have highlighted the crucial role of right ventricular (RV) function in hemodynamic and respiratory diseases in critical care 1,2. However, RV failure is difficult to define in the critical care setting. A recent consensual definition proposed by different groups of experts characterizes RV failure as the association of a significant RV dilatation associated with systemic congestion 3-5. This definition is mainly physiologically based, not strictly validated, and the experts did not propose any threshold for RV size or congestion using critical care echocardiography (CCE) and central venous pressure (CVP), respectively.
Fluid management in septic shock is crucial for prognosis, as fluid overload and high CVP are associated with a worse outcome 6. Septic shock is expected to impair RV function through the development of septic cardiomyopathy, but the incidence of RV failure is unknown.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Septic shock patients
Key inclusion criteria (2 listed)
- Patients diagnosed with septic shock.
- Patients will be evaluated within 24 h after diagnosis.
Key exclusion criteria (2 listed)
- Patients diagnosed more than 24 hours.
- Patients with associated ischemic heart failure .
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
Right ventricular dysfunction in septic shock patients in intensive care unit
Time frame: 3 years
Fluid management in septic shock is crucial for prognosis, as fluid overload and high CVP are associated with a worse outcome 6. Septic shock is expected to impair RV function through the development of septic cardiomyopathy, but the incidence of RV failure is unknown.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2022.
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Sepsis - to Reduce Mortality in the Intensive Care Unit, Septic Shock
Not yet recruiting
Hemodynamic Resuscitation Guided by Non-Invasive Mean Systemic Filling Pressure to Prevent Acute Kidney Injury in Septic Shock
Acute Kidney Injury Due to Sepsis
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Clinical Value of EMR3 in Sepsis Diagnosis, Monitoring, and Prognosis: A Multicenter Prospective Observational Study
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Septic Shock
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A Trial of Adjunctive Fludrocortisone (50mcg, 100mcg or Placebo) in Critically Ill Patients With Septic Shock Receiving Hydrocortisone, Evaluating Survival and Functional Recovery and the Influence of Transcriptomic Response
Septic Shock
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Septic Shock, run by Shimaa Hammad Ahmed.
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 2 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 25 Oct 2022. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Right ventricular dysfunction in septic shock patients in intensive care unit (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Oct 2022.