SepsisNCT02120534
Serum CD14 and CD88 Mointoring in ICU
An observational study of Sepsis, run by Tanta University at 1 site in Egypt.
Trial summary
The present study will be conducted to determine the dynamic changes of serum soluble CD14 and the corresponding changes of serum CD88 and their correlation in critically ill sepsis and SIRS patients. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Sepsis
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2013to Oct 2014
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: A total of ninety-four patients will be included in the study. Forty seven patients are critically ill with evidence of sepsis during ICU stay (sepsis group) and forty seven patients are critically ill without evidence of infectious organism (SIRS group). At admission, Patients data include clinical status; SOFA score; central venous pressure; laboratory analysis and arterial blood gas analysis are measured. Routine cultures will be obtained. The attending physician will evaluate the patients for sepsis, severe sepsis, or septic shock as long as their stay in ICU. A serum level of CD 14 and CD88 will be monitored.
Who may be able to join
- The patients staying in ICU for more than 24 hours will be included in the study.
Who cannot join
- Patients received anti-inflammatory drugs or corticosteroids before admission, patients had immunosuppressive illness, patients had chronic organ failure; patients received massive blood transfusion; patients with radiation therapy and patients with previous organ transplantation will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Predictive Values of Serum Soluble CD14 Subtype and CD88 Monitoring in Critically Ill Patients.
The present study will be conducted to determine the dynamic changes of serum soluble CD14 and the corresponding changes of serum CD88 and their correlation in critically ill sepsis and SIRS patients.
Read the detailed description
A total of ninty four will be included in the study. Forty seven patients are critically ill with evidence of sepsis during ICU stay (sepsis group) and forty seven patients are critically ill without evidence of infectious organism (SIRS group). At admission, Patients data include clinical status; SOFA score; central venous pressure; laboratory analysis and arterial blood gas analysis are measured. Routine cultures will be obtained. The attending physician will evaluate the patients for sepsis, severe sepsis, or septic shock as long as their stay in ICU. A serum level of CD 14 and CD88 will be monitored.
- Conditions
- Sepsis
- Keywords
- soluble CD14 ,serum CD88,sepsis , SIRS.
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Sepsis group | Forty seven patients are critically ill with evidence of sepsis during ICU stay (sepsis group). At admission, Patients data include clinical status; SOFA score; central venous pressure; laboratory analysis and arterial blood gas analysis are measured. Routine cultures will be obtained. The attending physician will evaluate the patients for sepsis, severe sepsis, or septic shock as long as their stay in ICU. A serum level of CD 14 and CD88 will be monitored. | |
| SIRS group | Forty seven patients are critically ill without evidence of infectious organism (SIRS group). At admission, Patients data include clinical status; SOFA score; central venous pressure; laboratory analysis and arterial blood gas analysis are measured. Routine cultures will be obtained. The attending physician will evaluate the patients for sepsis, severe sepsis, or septic shock as long as their stay in ICU. A serum level of CD 14 and CD88 will be monitored. |
What is being measured
The primary outcome is the main question the study is designed to answer.
A serum soluble CD14
At admission, Patients data include clinical status; SOFA score; central venous pressure; laboratory analysis and arterial blood gas analysis are measured. Routine cultures will be obtained. The attending physician will evaluate the patients for sepsis, severe sepsis, or septic shock as long as their stay in ICU. A serum level of CD 14 will be monitored.
Measured: one week
Secondary outcomes (1)
Survival of ICU patients
Correlation of of serum soluble CD14 and the corresponding changes of serum CD88 and their correlation in critically ill sepsis and SIRS patients and survival.
Measured: Two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2014 (estimated)
- Study startMar 2013
- Primary completionApr 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayman Abd Al-maksoud Yousef, Tanta University
- Investigators
- Ayman A Yousef, MD, Principal investigator, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02120534
- Sponsor's protocol ID
- 1638/02/13
- Status last verified
- Dec 2014
- First submitted
- 18 Apr 2014
- Last updated
- 16 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Predictive Values of Serum Soluble CD14 Subtype and CD88 Monitoring in Critically Ill Patients.
- ClinicalTrials.gov ID
- NCT02120534
- Acronym / sponsor ID
- 1638/02/13
- Conditions
- Sepsis
- Keywords
- soluble CD14 ,serum CD88,sepsis , SIRS.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 22 Apr 2014 (estimated)
- 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 present study will be conducted to determine the dynamic changes of serum soluble CD14 and the corresponding changes of serum CD88 and their correlation in critically ill sepsis and SIRS patients.
Detailed description
A total of ninty four will be included in the study. Forty seven patients are critically ill with evidence of sepsis during ICU stay (sepsis group) and forty seven patients are critically ill without evidence of infectious organism (SIRS group). At admission, Patients data include clinical status; SOFA score; central venous pressure; laboratory analysis and arterial blood gas analysis are measured. Routine cultures will be obtained. The attending physician will evaluate the patients for sepsis, severe sepsis, or septic shock as long as their stay in ICU. A serum level of CD 14 and CD88 will be monitored.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sepsis group | – | –Forty seven patients are critically ill with evidence of sepsis during ICU stay (sepsis group). At admission, Patients data include clinical status; SOFA score; central venous pressure; laboratory analysis and arterial blood gas analysis are measured. Routine cultures will be obtained. The attending physician will evaluate the patients for sepsis, severe sepsis, or septic shock as long as their stay in ICU. A serum level of CD 14 and CD88 will be monitored. |
| SIRS group | – | –Forty seven patients are critically ill without evidence of infectious organism (SIRS group). At admission, Patients data include clinical status; SOFA score; central venous pressure; laboratory analysis and arterial blood gas analysis are measured. Routine cultures will be obtained. The attending physician will evaluate the patients for sepsis, severe sepsis, or septic shock as long as their stay in ICU. A serum level of CD 14 and CD88 will be monitored. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- A total of ninety-four patients will be included in the study. Forty seven patients are critically ill with evidence of sepsis during ICU stay (sepsis group) and forty seven patients are critically ill without evidence of infectious organism (SIRS group). At admission, Patients data include clinical status; SOFA score; central venous pressure; laboratory analysis and arterial blood gas analysis are measured. Routine cultures will be obtained. The attending physician will evaluate the patients for sepsis, severe sepsis, or septic shock as long as their stay in ICU. A serum level of CD 14 and CD88 will be monitored.
Key inclusion criteria (1 listed)
- The patients staying in ICU for more than 24 hours will be included in the study.
Key exclusion criteria (1 listed)
- Patients received anti-inflammatory drugs or corticosteroids before admission, patients had immunosuppressive illness, patients had chronic organ failure; patients received massive blood transfusion; patients with radiation therapy and patients with previous organ transplantation will be excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
A serum soluble CD14
Time frame: one week
At admission, Patients data include clinical status; SOFA score; central venous pressure; laboratory analysis and arterial blood gas analysis are measured. Routine cultures will be obtained. The attending physician will evaluate the patients for sepsis, severe sepsis, or septic shock as long as their stay in ICU. A serum level of CD 14 will be monitored.
1 secondary outcome
Survival of ICU patients
Time frame: Two weeks
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 16 Dec 2014.
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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.
Ayman A Yousef, MD principal investigator
Assistant Professor
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 Sepsis, run by Tanta 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 1 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 16 Dec 2014. 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?
A serum soluble CD14 (time frame: one week). 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 16 Dec 2014; AzTrials last refreshed its copy on 31 Oct 2026.