Septic PatientsNCT03359369
Prognostic Value of Serum Cholesterol and Triglyceride in Septic and Non Septic Patients
An observational study of Septic Patients and Nonseptic Patients, run by Beni-Suef University at 1 site in Egypt.
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… Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Septic Patients, Nonseptic Patients
- What is being tested?
- level of serum cholesterol and triglyceride
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Jan 2018to 13 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Septic Patients, Nonseptic Patients
- Being tested
- level of serum cholesterol and triglyceride
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
level of serum cholesterol and triglycerideDiagnostic test
other
| Study group | Role | What they receive |
|---|---|---|
| Septic Patients | Not described Receives: Diagnostic Test: level of serum cholesterol and triglyceride | |
| Non Septic Patients | Not described Receives: Diagnostic Test: level of serum cholesterol and triglyceride |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in the level of serum cholesterol and triglyceride
change in the level of serum cholesterol and triglyceride
Measured: on days 0, 1, 3, and 7, 10 and 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2017
- Study start7 Jan 2018
- Primary completion13 Nov 2018
- Study completion13 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic PatientsStudies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, doaa rashwan, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03359369
- Sponsor's protocol ID
- doaa rashwan
- Status last verified
- Dec 2018
- First submitted
- 24 Nov 2017
- Last updated
- 3 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Serum Cholesterol and Triglyceride in Septic and Non Septic Patients: Randomized Double Blinded Study
- ClinicalTrials.gov ID
- NCT03359369
- Acronym / sponsor ID
- doaa rashwan
- Conditions
- Septic Patients, Nonseptic Patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 7 Jan 2018 (actual)
- Primary completion
- 13 Nov 2018 (actual)
- Study completion
- 13 Dec 2018 (actual)
- First posted
- 2 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Septic Patients | – | Diagnostic Test: level of serum cholesterol and triglyceride |
| Non Septic Patients | – | Diagnostic Test: level of serum cholesterol and triglyceride |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (9 listed)
- Age less than 20
- Pregnancy
- ICU readmission
- Dyslipidemia
- Patients with liver disease e.g.hepatitis B,hepatitis C , liver cirrhosis, and hepatocellular carcinoma)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| level of serum cholesterol and triglycerideother | Diagnostic test | Non Septic Patients, Septic Patients |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Septic Patients and Nonseptic Patients, run by Beni-Suef University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in the level of serum cholesterol and triglyceride (time frame: on days 0, 1, 3, and 7, 10 and 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2019.