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

Septic Patients Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03359369
• Other study ID #: doaa rashwan
• Status: Completed
• Start date: January 7, 2018
• Est. completion date: December 13, 2018

Study information

• Verified date: December 2018
• Source: Beni-Suef University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 13, 2018
• Est. primary completion date: November 13, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Nonseptic Patients
• Septic Patients

Intervention

Diagnostic Test:
• level of serum cholesterol and triglyceride
other

Locations

Country	Name	City	State
Egypt	Faculty Of Medicine, Beni-Suef University	Bani Suwayf

Sponsors (1)

Lead Sponsor	Collaborator
Beni-Suef University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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