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Completed

NCT Number: NCT03359369

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

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.

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Key information

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty Of Medicine, Beni-Suef University

Banī Suwayf, 11391, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

level of serum cholesterol and triglyceride

Diagnostic Test

other

Primary outcomes

  1. change in the level of serum cholesterol and triglyceride

    Time frame: on days 0, 1, 3, and 7, 10 and 14 days

    change in the level of serum cholesterol and triglyceride

Sponsors and collaborators

Lead sponsor

Beni-Suef University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Dec 2, 2017
Registry last updated
Jan 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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