The Relation Between Triglyceride- Glucose Index, Procalcitonin and Cardiac Affection in Septic Shock.

NCT06518083 | Not Yet Recruiting DMC

• 1 other identifier: 04-2024-100269
• Study Type: observational
• Target: 88
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Septic Shock

Outcome Measures

Primary Outcomes (1)

• 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

  3 months

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• Adult patients (≥18 years) 2-Patients admitted to the ICU with septic shock.

You may not qualify if:

• Patients who have mixed aetiology of shock. 2-Known previous cardiac disease ( cardiovascular disease, heart failure, arrhythmia )

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant -lecturer of critical care

Study Record Dates

• First Submitted: July 11, 2024
• First Posted: July 24, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2027
• Last Updated: July 24, 2024

Record last verified: 2024-07