NCT03359369

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 24, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 2, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

January 7, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 13, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2018

Completed
Last Updated

January 3, 2019

Status Verified

December 1, 2018

Enrollment Period

10 months

First QC Date

November 24, 2017

Last Update Submit

December 31, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Septic Patients

Diagnostic Test: level of serum cholesterol and triglyceride

Non Septic Patients

Diagnostic Test: level of serum cholesterol and triglyceride

Interventions

other

Non Septic PatientsSeptic Patients

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty Of Medicine, Beni-Suef University

Banī Suwayf, 11391, Egypt

Location

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

November 24, 2017

First Posted

December 2, 2017

Study Start

January 7, 2018

Primary Completion

November 13, 2018

Study Completion

December 13, 2018

Last Updated

January 3, 2019

Record last verified: 2018-12

Locations