Sepsis and Septic ShockNCT06193109
The Prognostic Impact of Right Ventricular Systolic Dysfunction on the Survival of Patients With Sepsis and Septic Shock
An observational study of Sepsis and Septic Shock, run by Burapha University at 1 site in Thailand.
Trial summary
This study sought to evaluate the association of right ventricular systolic dysfunction and 28-day in-hospital mortality in patients with sepsis and septic shock. Prospective cohort study of adult patients admitted at Burapha university hospital from October 1, 2022 through June 30, 2023 for sepsis and septic shock… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis and Septic Shock
- How many people
- 200 participants
- Where
- 1 siteThailand
- Study dates
- 1 Oct 2022to 30 Jul 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A prospective study was conducted at Burapha University Hospital, enrolling admitted patients diagnosed with sepsis and septic shock. Echocardiography was performed on these patients within 72 hours after admission
Who may be able to join
- aged 18 years or older
- diagnosed with sepsis or septic shock according to Sepsis-3 criteria
- received an echocardiogram within 72 hours after admission
Who cannot join
- prior diagnosis of pulmonary hypertension,
- cor-pulmonale,
- significant valvular heart disease,
- acute coronary syndrome,
- aortic dissection,
- heart failure
- inability to follow up within 28 days
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Burapha University Hospital
Muang Chonburi, Changwat Chon Buri, 20131
About this study
This study sought to evaluate the association of right ventricular systolic dysfunction and 28-day in-hospital mortality in patients with sepsis and septic shock. Prospective cohort study of adult patients admitted at Burapha university hospital from October 1, 2022 through June 30, 2023 for sepsis and septic shock, who had an echocardiogram within 72 hours after admission for evaluating right ventricular systolic function. Right ventricular systolic dysfunction was defned by the American Society of Echocardiography criteria. Outcomes included 28-day in-hospital mortality, maximal blood lactate, length of intensive care unit(ICU) stay and duration of mechanical ventilation.
- Conditions
- Sepsis and Septic Shock
- Keywords
- right ventricular systolic dysfunction
- Medical subject headings
- Sepsis, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
the patients with sepsis and septic shock were performed echocardiography for detecting right ventricular systolic function
| Study group | Role | What they receive |
|---|---|---|
| the patients with sepsis or septic shock | devide two groups : (1) They had right ventricular dysfunction and (2) They had no right venticular dysfunction. |
What is being measured
The primary outcome is the main question the study is designed to answer.
28 days in-hospital mortality
28 days in hospital mortality in patients with sepsis or septic shock
Measured: October 1, 2022 and June 30, 2023
Secondary outcomes (4)
The prevalence of right ventricular systolic dysfunction
The prevalence of right ventricular systolic dysfunction in patients with sepsis and septic shock
Measured: October 1, 2022 and June 30, 2023
Blood lactate levels
Blood lactate levels in patients with sepsis and septic shock
Measured: October 1, 2022 and June 30, 2023
Lenght of ICU stay
Lenght of ICU stay in patients with sepsis and septic shock
Measured: October 1, 2022 and June 30, 2023
Duration of mechanical ventilation
Duration of mechanical ventilation in patients with sepsis and septic shock
Measured: October 1, 2022 and June 30, 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start1 Oct 2022
- Primary completion30 Jun 2023
- Study completion30 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sepsis and 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Burapha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sukrisd Koowattanatianchai, Burapha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06193109
- Sponsor's protocol ID
- Burapha university
- Status last verified
- Dec 2023
- First submitted
- 12 Dec 2023
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Koowattanatianchai S, Kochaiyapatana P, Eungsuwat N, Rangsrisaeneepitak V, Thammakumpee K, Kaladee K. Significance of Right Ventricular Dysfunction in Predicting Short-Term Survival Among Patients With Sepsis and Septic Shock: A Prognostic Analysis. Crit Care Res Pract. 2025 Mar 14;2025:5511135. doi: 10.1155/ccrp/5511135. eCollection 2025.
PubMed 40125344
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prognostic Impact of Right Ventricular Systolic Dysfunction on the Survival of Patients With Sepsis and Septic Shock
- ClinicalTrials.gov ID
- NCT06193109
- Acronym / sponsor ID
- Burapha university
- Conditions
- Sepsis and Septic Shock
- Keywords
- right ventricular systolic dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Burapha UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jul 2023 (actual)
- First posted
- 5 Jan 2024 (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.
This study sought to evaluate the association of right ventricular systolic dysfunction and 28-day in-hospital mortality in patients with sepsis and septic shock. Prospective cohort study of adult patients admitted at Burapha university hospital from October 1, 2022 through June 30, 2023 for sepsis and septic shock, who had an echocardiogram within 72 hours after admission for evaluating right ventricular systolic function. Right ventricular systolic dysfunction was defned by the American Society of Echocardiography criteria. Outcomes included 28-day in-hospital mortality, maximal blood lactate, length of intensive care unit(ICU) stay and duration of mechanical ventilation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| the patients with sepsis or septic shock | – | –devide two groups : (1) They had right ventricular dysfunction and (2) They had no right venticular dysfunction. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A prospective study was conducted at Burapha University Hospital, enrolling admitted patients diagnosed with sepsis and septic shock. Echocardiography was performed on these patients within 72 hours after admission
Key inclusion criteria (3 listed)
- aged 18 years or older
- diagnosed with sepsis or septic shock according to Sepsis-3 criteria
- received an echocardiogram within 72 hours after admission
Key exclusion criteria (7 listed)
- prior diagnosis of pulmonary hypertension,
- cor-pulmonale,
- significant valvular heart disease,
- acute coronary syndrome,
- aortic dissection,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| the patients with sepsis and septic shock were performed echocardiography for detecting right ventricular systolic function | Other | the patients with sepsis or septic shock |
Primary outcome
28 days in-hospital mortality
Time frame: October 1, 2022 and June 30, 2023
28 days in hospital mortality in patients with sepsis or septic shock
4 secondary outcomes
The prevalence of right ventricular systolic dysfunction
Time frame: October 1, 2022 and June 30, 2023
Blood lactate levels
Time frame: October 1, 2022 and June 30, 2023
Lenght of ICU stay
Time frame: October 1, 2022 and June 30, 2023
Duration of mechanical ventilation
Time frame: October 1, 2022 and June 30, 2023
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Derived from this study: PubMed 40125344Koowattanatianchai S, Kochaiyapatana P, Eungsuwat N, Rangsrisaeneepitak V, Thammakumpee K, Kaladee K. Significance of Right Ventricular Dysfunction in Predicting Short-Term Survival Among Patients With Sepsis and Septic Shock: A Prognostic Analysis. Crit Care Res Pract. 2025 Mar 14;2025:5511135. doi: 10.1155/ccrp/5511135. eCollection 2025.
- Individual participant dataSharing planned: Yes
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Sepsis
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Septic Shock, run by Burapha University at 1 site in Thailand.
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 3 inclusion and 7 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: finished, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
28 days in-hospital mortality (time frame: October 1, 2022 and June 30, 2023). 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 NCT06193109, which also lists 1 linked publication.
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 5 Jan 2024.