Septic ShockNCT06518083
The Relation Between Triglyceride- Glucose Index, Procalcitonin and Cardiac Affection in Septic Shock.
An observational study of Septic Shock, run by Assiut University.
Trial summary
The study is carried out to demonstrate the relation between Triglyceride -glucose index and cardiac affection in the patients admitted to the ICU with septic shock. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Septic Shock
- How many people
- 88 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2024to 31 Jul 2027
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Sample size calculation was carried out using G*Power 3 software (Faul et al., 2007) 1. A calculated minimum sample of 88 patients admitted to the ICU with septic shock will be needed to detect an effect size of 0.5 in the effect of TGD index variability on the cardiac affection in septic shock cases (OR 1.597; 95% CI 1.18 - 2.15)2, with an error probability of 0.05 and 80% power on a one-tailed test with normal x-distribution. The sample will be raised by 10% to compensate for dropouts, attrition and non-response to be 100 participants. 1. Faul, F., Erdfelder, E., Lang, A.-G. \& Buchner, A. (2007). G*Power 3: A flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behavior Research Methods, 39, 175-191.
Who may be able to join
- 1- Adult patients (≥18 years) 2-Patients admitted to the ICU with septic shock.
Who cannot join
- 1-Patients who have mixed aetiology of shock. 2-Known previous cardiac disease ( cardiovascular disease, heart failure, arrhythmia )
About this study
Official title: The Relation Between Dynamic Change in Triglyceride- Glucose Index, Procalcitonin and Cardiac Affection in Patients Admitted to the Intensive Care Unit With Septic Shock.
The study is carried out to demonstrate the relation between Triglyceride -glucose index and cardiac affection in the patients admitted to the ICU with septic shock.
Read the detailed description
Sepsis, a condition characterized by a dysregulated immune response to infection, is a prominent contributor to global mortality(1).
Insulin resistance (IR) is typified by reduced insulin sensitivity in peripheral tissues and is linked to various pathological conditions ( 2) The triglyceride-glucose (TyG) index, recognized as a surrogate marker of insulin resistance, has recently gained attention as a potential prognostic tool for various metabolic and cardiovascular diseases . ( 3) Preliminary investigations have revealed a correlation between metabolic disorders characterized by dysregulated lipid and glucose metabolism and the severity of sepsis. Notably, a high TyG index has been associated with increased in-hospital mortality in sepsis patients (4) studies only focused on the initial TyG value within the first 24 h of ICU admission and did not consider the dynamic changes in this marker over time. As insulin sensitivity in critically ill patients can change over time, (5) ,(6) It is possible that the TyG variability ratio (TyGVR) during hospital stay may be a better marker for adverse long-term prognosis and could be used for early risk stratification in critically ill patients, Procalcitonin (PCT) is produced during bacterial infections, sepsis, cardiogenic shock, major surgery, burns, multiple trauma, and after cardiac surgery( 7.8)
In this study we will discuss the relation between dynamic changes in both TyG index, procalcitonin and cardiac affection in the ICU patients admitted with septic shock.
- Conditions
- Septic Shock
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| one group of patients with septic shock admitted to the ICU | The patients with septic shock admitted to the ICU will be observed for occurrence of cardiac events and their relation to triglyceride-glucose index and procalcitonin |
What is being measured
The primary outcome is the main question the study is designed to answer.
1- To evaluate the effect of TyG index of on mortality of patients with septic shock..
follow up the effect of elevated TyG index on increased mortality
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2024
- Study start1 Aug 2024 (estimated)
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2027 (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.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 88 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Fawzi Ibrahim Mansour, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06518083
- Sponsor's protocol ID
- 04-2024-100269
- Status last verified
- Jul 2024
- First submitted
- 11 Jul 2024
- Last updated
- 24 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relation Between Dynamic Change in Triglyceride- Glucose Index, Procalcitonin and Cardiac Affection in Patients Admitted to the Intensive Care Unit With Septic Shock.
- ClinicalTrials.gov ID
- NCT06518083
- Acronym / sponsor ID
- 04-2024-100269
- Conditions
- Septic Shock
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 24 Jul 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.
The study is carried out to demonstrate the relation between Triglyceride -glucose index and cardiac affection in the patients admitted to the ICU with septic shock.
Detailed description
Sepsis, a condition characterized by a dysregulated immune response to infection, is a prominent contributor to global mortality(1).
Insulin resistance (IR) is typified by reduced insulin sensitivity in peripheral tissues and is linked to various pathological conditions ( 2) The triglyceride-glucose (TyG) index, recognized as a surrogate marker of insulin resistance, has recently gained attention as a potential prognostic tool for various metabolic and cardiovascular diseases . ( 3) Preliminary investigations have revealed a correlation between metabolic disorders characterized by dysregulated lipid and glucose metabolism and the severity of sepsis. Notably, a high TyG index has been associated with increased in-hospital mortality in sepsis patients (4) studies only focused on the initial TyG value within the first 24 h of ICU admission and did not consider the dynamic changes in this marker over time. As insulin sensitivity in critically ill patients can change over time, (5) ,(6) It is possible that the TyG variability ratio (TyGVR) during hospital stay may be a better marker for adverse long-term prognosis and could be used for early risk stratification in critically ill patients, Procalcitonin (PCT) is produced during bacterial infections, sepsis, cardiogenic shock, major surgery, burns, multiple trauma, and after cardiac surgery( 7.8)
In this study we will discuss the relation between dynamic changes in both TyG index, procalcitonin and cardiac affection in the ICU patients admitted with septic shock.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| one group of patients with septic shock admitted to the ICU | – | –The patients with septic shock admitted to the ICU will be observed for occurrence of cardiac events and their relation to triglyceride-glucose index and procalcitonin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Sample size calculation was carried out using G*Power 3 software (Faul et al., 2007) 1. A calculated minimum sample of 88 patients admitted to the ICU with septic shock will be needed to detect an effect size of 0.5 in the effect of TGD index variability on the cardiac affection in septic shock cases (OR 1.597; 95% CI 1.18 - 2.15)2, with an error probability of 0.05 and 80% power on a one-tailed test with normal x-distribution. The sample will be raised by 10% to compensate for dropouts, attrition and non-response to be 100 participants. 1. Faul, F., Erdfelder, E., Lang, A.-G. \& Buchner, A. (2007). G*Power 3: A flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behavior Research Methods, 39, 175-191.
Key inclusion criteria (1 listed)
- 1- Adult patients (≥18 years) 2-Patients admitted to the ICU with septic shock.
Key exclusion criteria (1 listed)
- 1-Patients who have mixed aetiology of shock. 2-Known previous cardiac disease ( cardiovascular disease, heart failure, arrhythmia )
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
1- To evaluate the effect of TyG index of on mortality of patients with septic shock..
Time frame: 3 months
follow up the effect of elevated TyG index on increased mortality
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2024.
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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.
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 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 1 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: opening soon, as of the sponsor's last update on 24 Jul 2024. 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?
This study is still under way. Results are not available in the source record yet.
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?
1- To evaluate the effect of TyG index of on mortality of patients with septic shock.. (time frame: 3 months). 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 24 Jul 2024.