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

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.

Study Overview

• Status: Completed
• Conditions: Septic Patients; Nonseptic Patients
• Intervention / Treatment: Diagnostic test: level of serum cholesterol and triglyceride

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.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Egypt
  • Banī Suwayf, Egypt, 11391
    • Faculty of Medicine, Beni-suef University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Septic Patients	Diagnostic test: level of serum cholesterol and triglyceride; other
Non Septic Patients	Diagnostic test: level of serum cholesterol and triglyceride; other

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in the level of serum cholesterol and triglyceride	change in the level of serum cholesterol and triglyceride	on days 0, 1, 3, and 7, 10 and 14 days

Collaborators and Investigators

• Sponsor: Beni-Suef University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 7, 2018
• Primary Completion (ACTUAL): November 13, 2018
• Study Completion (ACTUAL): December 13, 2018

Study Registration Dates

• First Submitted: November 24, 2017
• First Submitted That Met QC Criteria: November 30, 2017
• First Posted (ACTUAL): December 2, 2017

Study Record Updates

• Last Update Posted (ACTUAL): January 3, 2019
• Last Update Submitted That Met QC Criteria: December 31, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: doaa rashwan

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No