SepsisNCT01708772
Serum TNF-a in Comparison to Sequential Organ Failure Assessment (SOFA) Score Monitoring in Critically Ill Patients
An observational study of Sepsis and Critically Ill, run by Tanta University at 1 site in Egypt.
Trial summary
A total of ninety patients (52men and 38women) were included in the study. Forty five patients developed septic complication during ICU stay (sepsis group). Forty five patients were critically ill without evidence of infectious organism (SIRS group). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Sepsis, Critically Ill
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- Nov 2012to Jan 2013
- 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 patients (52men and 38women) were included in the study. Forty five patients developed septic complication during ICU stay (sepsis group). Forty five patients were critically ill without evidence of infectious organism (SIRS group). Patients were classified into their groups at the time of the first blood analysis for these biomarkers at ICU admission.
Who may be able to join
- The patients staying in ICU for more than 24 hours were enrolled in the study.
Who cannot join
- The 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 were excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Predictive Prognostic Values of Serum TNF-a in Comparison to SOFA Score Monitoring in Critically Ill Patients
A total of ninety patients (52men and 38women) were included in the study. Forty five patients developed septic complication during ICU stay (sepsis group). Forty five patients were 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 were measured. Routine cultures were obtained. The attending physician evaluated the patients for sepsis, severe sepsis, or septic shock as long as their stay in ICU. A serum level of TNF-a and SOFA score was monitored.
Read the detailed description
The patients staying in ICU for more than 24 hours were enrolled in the study. 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 were excluded from the study. At admission, patient's age, sex, weight and height were recorded. Patients data that include the clinical status; sequential organ failure assessment (SOFA) score; temperature; heart rate; respiratory rate; blood pressure; central venous pressure; laboratory analysis (complete blood count, blood urea nitrogen, blood sugar, serum sodium, potassium, calcium, aspartate aminotransferase, alanine aminotransferase, prothrombin time, albumin and CRP) and arterial blood gas analysis were measured. Routine cultures of suspected sites, blood and urine were obtained to determine the presence of infection. We attempted to maintain the patient hemoglobin level at 10-12g/dl and central venous pressure at 8-12 cmH2o. When needed, intravascular fluid replacement, blood products and inotropic or vasopressor agents were administered. Each day the attending physician evaluated all the study patients for sepsis, severe sepsis, or septic shock as long as their stay in ICU.
- Conditions
- Sepsis, Critically Ill
- Keywords
- TNF alpha, SOFA score
- Medical subject headings
- Sepsis, Critical Illness
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 | Forty five patients developed septic complication during ICU stay (sepsis group). | |
| SIRS group | Forty five patients were critically ill without evidence of infectious organism (SIRS group). |
What is being measured
The primary outcome is the main question the study is designed to answer.
TNF-a determination using ELISA.
A serum level of TNF-a was determined by quantitative sandwich enzyme immunoassay (R\&D Systems, Inc., Minneapolis, MN, USA) guided by to the manufacturer's instructions. The intensity of the color was measured at 490 nm.
Measured: Participants will be followed for the duration of ICU stay, At admission, 3rd, 5th and 7th day of ICU stay.Patients will be followed for at least 2 weeks.
Secondary outcomes (1)
Evaluation of SOFA score:
SOFA score is composed of scores of six organ systems (respiratory [R], cardiovascular [C], hepatic [H], coagulation [Co], renal [Re], and neurological [N]) graded from 0 to 4 according to the degree of dysfunction/ failure.
Measured: Participants will be followed for the duration of ICU stay, at admission, 3rd, 5th, and 7th day of ICU stay.Patients will be followed for at least 2 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2012 (estimated)
- Study startNov 2012
- Primary completionDec 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 90 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 os Anesthesia and ICU, Faculty of Medicine, Tanta university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01708772
- Sponsor's protocol ID
- 1381/09/12
- Status last verified
- Jun 2013
- First submitted
- 10 Oct 2012
- Last updated
- 7 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ferrerira FL, Bota DP, Bross A, Melot C, Vincent JL. Serial evaluation of the SOFA score to predict outcome in critically ill patients. JAMA 2001:286(14):1754-1758. Sheeran P, Hall GM. Cytokine balance and immunosuppressive changes at cardiac surgery. Br J Anaesth 1996; 77: 129-30. Robertshaw H J, Brennan F M. Release of tumour necrosis factor a (TNF-a) by TNF a cleaving enzyme (TACE) in response to septic stimuli in vitro. Br J Anaesth 2005; 94: 222-8.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Predictive Prognostic Values of Serum TNF-a in Comparison to SOFA Score Monitoring in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT01708772
- Acronym / sponsor ID
- 1381/09/12
- Conditions
- Sepsis, Critically Ill
- Keywords
- TNF alpha, SOFA score
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 17 Oct 2012 (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.
A total of ninety patients (52men and 38women) were included in the study. Forty five patients developed septic complication during ICU stay (sepsis group). Forty five patients were 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 were measured. Routine cultures were obtained. The attending physician evaluated the patients for sepsis, severe sepsis, or septic shock as long as their stay in ICU. A serum level of TNF-a and SOFA score was monitored.
Detailed description
The patients staying in ICU for more than 24 hours were enrolled in the study. 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 were excluded from the study. At admission, patient's age, sex, weight and height were recorded. Patients data that include the clinical status; sequential organ failure assessment (SOFA) score; temperature; heart rate; respiratory rate; blood pressure; central venous pressure; laboratory analysis (complete blood count, blood urea nitrogen, blood sugar, serum sodium, potassium, calcium, aspartate aminotransferase, alanine aminotransferase, prothrombin time, albumin and CRP) and arterial blood gas analysis were measured. Routine cultures of suspected sites, blood and urine were obtained to determine the presence of infection. We attempted to maintain the patient hemoglobin level at 10-12g/dl and central venous pressure at 8-12 cmH2o. When needed, intravascular fluid replacement, blood products and inotropic or vasopressor agents were administered. Each day the attending physician evaluated all the study patients for sepsis, severe sepsis, or septic shock as long as their stay in ICU.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sepsis | – | –Forty five patients developed septic complication during ICU stay (sepsis group). |
| SIRS group | – | –Forty five patients were critically ill without evidence of infectious organism (SIRS group). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- A total of ninety patients (52men and 38women) were included in the study. Forty five patients developed septic complication during ICU stay (sepsis group). Forty five patients were critically ill without evidence of infectious organism (SIRS group). Patients were classified into their groups at the time of the first blood analysis for these biomarkers at ICU admission.
Key inclusion criteria (1 listed)
- The patients staying in ICU for more than 24 hours were enrolled in the study.
Key exclusion criteria (3 listed)
- The 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 were 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
TNF-a determination using ELISA.
Time frame: Participants will be followed for the duration of ICU stay, At admission, 3rd, 5th and 7th day of ICU stay.Patients will be followed for at least 2 weeks.
A serum level of TNF-a was determined by quantitative sandwich enzyme immunoassay (R\&D Systems, Inc., Minneapolis, MN, USA) guided by to the manufacturer's instructions. The intensity of the color was measured at 490 nm.
1 secondary outcome
Evaluation of SOFA score:
Time frame: Participants will be followed for the duration of ICU stay, at admission, 3rd, 5th, and 7th day of ICU stay.Patients will be followed for at least 2 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 7 Jun 2013.
- BackgroundFerrerira FL, Bota DP, Bross A, Melot C, Vincent JL. Serial evaluation of the SOFA score to predict outcome in critically ill patients. JAMA 2001:286(14):1754-1758. Sheeran P, Hall GM. Cytokine balance and immunosuppressive changes at cardiac surgery. Br J Anaesth 1996; 77: 129-30. Robertshaw H J, Brennan F M. Release of tumour necrosis factor a (TNF-a) by TNF a cleaving enzyme (TACE) in response to septic stimuli in vitro. Br J Anaesth 2005; 94: 222-8.
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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 os Anesthesia and ICU, Faculty of Medicine, Tanta university
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 and Critically Ill, 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 3 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 7 Jun 2013. 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?
TNF-a determination using ELISA. (time frame: Participants will be followed for the duration of ICU stay, At admission, 3rd, 5th and 7th day of ICU stay.Patients will be followed for at least 2 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01708772, which also lists 1 linked publication.
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 7 Jun 2013.