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Prognostic Value of Serum Cholesterol and Triglyceride in Septic and Non Septic Patients

Prognostic Value of Serum Cholesterol and Triglyceride in Septic and Non Septic Patients: Randomized Double Blinded Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03359369
Enrollment
100
Registered
2017-12-02
Start date
2018-01-07
Completion date
2018-12-13
Last updated
2019-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nonseptic Patients, Septic Patients

Brief summary

The primary outcome of this study is to evaluate the difference between the level of serum cholesterol and triglyceride in septic and non septic patients in the ICU. . The secondary outcome will be to find correlation between the level of serum cholesterol and triglyceride and both Acute physiology And Chronic Health Evaluation Score (APACHE) II(19) and quick Sequential Organ Failure Assessment (qSOFA) score (20) and their relation to mortality.

Detailed description

Type and Site of The study: This study will be be done at Beni-Suef university hospital SICU after approval of the local ethics and research committee and anesthesia department of Beni-Suef University. DATE AND PERIOD OF THE STUDY: The study will be done between June 2017 and June 2018 Study population: The study population will include the patients (age range between 20 and 70)of both sex (septic and non septic patients e.g. trauma patients, post surgical patients) who will be admitted to the surgical intensive care in Beni Suef University hospital. Sample size estimation: Sample technique: The patients will be randomly assigned into two groups, septic patients (groups) according to established consensus definitions (21) or non septic patients (NS) as post surgical and trauma patients. The following data will be recorded for each patient: age, sex,weight, cause of ICU admission, administration of vasoactive drugs, length of ICU stay, 28-day mortality, administration of vasoactive drugs, days on mechanical ventilation, Acute Physiology and Chronic Health Evaluation II (APACHE II) scores, quick Sequential Organ Failure Assessment (qSOFA) scores will be recorded. The following laboratory data will be measured: cholesterol, triglyceride on days 0 (ICU admission), 1, 3, and 7, 10 and 14.

Interventions

DIAGNOSTIC_TESTlevel of serum cholesterol and triglyceride

other

Sponsors

Beni-Suef University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* The study population will include the patients (age range between 20 and 70) of both sex (septic and non septic patients e.g. trauma patients, post surgical patients) who will be admitted to the surgical intensive care in Beni-Suef University hospital

Exclusion criteria

* Age less than 20 * Pregnancy * ICU readmission * Dyslipidemia * Patients with liver disease e.g.hepatitis B,hepatitis C , liver cirrhosis, and hepatocellular carcinoma) * Concomitant of use immunosuppressive therapy * Using statin or steroid (≥15mg/day) within the previous 7 days * Patients who had been treated with corticosteroid therapy for septic shock prior to admission to ICU * Patients sedated by propofol

Design outcomes

Primary

MeasureTime frameDescription
change in the level of serum cholesterol and triglycerideon days 0, 1, 3, and 7, 10 and 14 dayschange in the level of serum cholesterol and triglyceride

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026