Serial Endocan MeasurementsNCT02916277
Endocan in Ventilator-associated Pneumonia
An observational study of Serial Endocan Measurements, run by Erzincan University at 1 site in Turkey (Türkiye).
Trial summary
In this study; in patients undergoing mechanical ventilation, making the day series Endocan measurements during the first 5 day to look at whether there is a relationship between the levels of VAP with Endocan. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Serial Endocan Measurements
- What is being tested?
- endocan
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Aug 2016to Mar 2017
- How long will I take part?
- 5 Days
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients whether intubated and connected to a mechanical ventilator
Who may be able to join
- over 18 age
- Patients whether intubated and connected to a mechanical ventilator
Who cannot join
- patients intubated due to lung problems such as COPD, asthma, pulmonary embolism , etc.
- Patients with brain tumors
- patients with acute and chronic renal failure
- Patients with hypertension
- Patients with previously diagnosed infection
- Patients with extubated
- patients using antibiotics or corticosteroids before bronchoalveolar lavage fluid samples taken
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Erzincan University
Erzincan
FATIH OZCICEK, fozcicek@hotmail.com
About this study
Official title: Endocan; Can be a New Biomarker in Ventilator-associated Pneumonia?
In this study; in patients undergoing mechanical ventilation, making the day series Endocan measurements during the first 5 day to look at whether there is a relationship between the levels of VAP with Endocan. This relationship, if any, aimed to investigate whether correlated with clinical and laboratory findings [presence of fever, pathological lung X-ray, the number of white blood cells (WBC), procalcitonin (PCT), C-reactive protein (CRP)] .
- Conditions
- Serial Endocan Measurements
- Being tested
- endocan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endocanBiological
to look series Endocan level for 5 days in intubated patients
What is being measured
The primary outcome is the main question the study is designed to answer.
relationship between the level of Endocan and development of VAP
Measured: 9 month
Secondary outcomes (1)
correlation with the level of Endocan and clinical and laboratory findings
Measured: 9 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2016 (estimated)
- Study startAug 2016
- Primary completionFeb 2017 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Serial Endocan MeasurementsStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 5 Days
Sponsor and investigators
- Lead sponsor
- Erzincan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ILKE KUPELI, Erzincan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02916277
- Sponsor's protocol ID
- ERZINCAN UNIVERSITY 3
- Status last verified
- Sep 2016
- First submitted
- 24 Sep 2016
- Last updated
- 27 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Fagon JY, Chastre J, Wolff M, Gervais C, Parer-Aubas S, Stephan F, Similowski T, Mercat A, Diehl JL, Sollet JP, Tenaillon A. Invasive and noninvasive strategies for management of suspected ventilator-associated pneumonia. A randomized trial. Ann Intern Med. 2000 Apr 18;132(8):621-30. doi: 10.7326/0003-4819-132-8-200004180-00004.
PubMed 10766680Mayhall CG. Ventilator-associated pneumonia or not? Contemporary diagnosis. Emerg Infect Dis. 2001 Mar-Apr;7(2):200-4. doi: 10.3201/eid0702.010209.
PubMed 11294706Gibot S, Cravoisy A, Levy B, Bene MC, Faure G, Bollaert PE. Soluble triggering receptor expressed on myeloid cells and the diagnosis of pneumonia. N Engl J Med. 2004 Jan 29;350(5):451-8. doi: 10.1056/NEJMoa031544.
PubMed 14749453Bechard D, Gentina T, Delehedde M, Scherpereel A, Lyon M, Aumercier M, Vazeux R, Richet C, Degand P, Jude B, Janin A, Fernig DG, Tonnel AB, Lassalle P. Endocan is a novel chondroitin sulfate/dermatan sulfate proteoglycan that promotes hepatocyte growth factor/scatter factor mitogenic activity. J Biol Chem. 2001 Dec 21;276(51):48341-9. doi: 10.1074/jbc.M108395200. Epub 2001 Oct 5.
PubMed 11590178Bechard D, Meignin V, Scherpereel A, Oudin S, Kervoaze G, Bertheau P, Janin A, Tonnel A, Lassalle P. Characterization of the secreted form of endothelial-cell-specific molecule 1 by specific monoclonal antibodies. J Vasc Res. 2000 Sep-Oct;37(5):417-25. doi: 10.1159/000025758.
PubMed 11025405Luyt CE, Combes A, Reynaud C, Hekimian G, Nieszkowska A, Tonnellier M, Aubry A, Trouillet JL, Bernard M, Chastre J. Usefulness of procalcitonin for the diagnosis of ventilator-associated pneumonia. Intensive Care Med. 2008 Aug;34(8):1434-40. doi: 10.1007/s00134-008-1112-x. Epub 2008 Apr 18.
PubMed 18421435Linssen CF, Bekers O, Drent M, Jacobs JA. C-reactive protein and procalcitonin concentrations in bronchoalveolar lavage fluid as a predictor of ventilator-associated pneumonia. Ann Clin Biochem. 2008 May;45(Pt 3):293-8. doi: 10.1258/acb.2007.007133.
PubMed 18482918Flanagan PG, Jackson SK, Findlay G. Diagnosis of gram negative, ventilator associated pneumonia by assaying endotoxin in bronchial lavage fluid. J Clin Pathol. 2001 Feb;54(2):107-10. doi: 10.1136/jcp.54.2.107.
PubMed 11215277el-Ebiary M, Torres A, Gonzalez J, Martos A, Puig de la Bellacasa J, Ferrer M, Rodriguez-Roisin R. Use of elastin fibre detection in the diagnosis of ventilator associated pneumonia. Thorax. 1995 Jan;50(1):14-7. doi: 10.1136/thx.50.1.14.
PubMed 7886642Lassalle P, Molet S, Janin A, Heyden JV, Tavernier J, Fiers W, Devos R, Tonnel AB. ESM-1 is a novel human endothelial cell-specific molecule expressed in lung and regulated by cytokines. J Biol Chem. 1996 Aug 23;271(34):20458-64. doi: 10.1074/jbc.271.34.20458.
PubMed 8702785Tang L, Zhao Y, Wang D, Deng W, Li C, Li Q, Huang S, Shu C. Endocan levels in peripheral blood predict outcomes of acute respiratory distress syndrome. Mediators Inflamm. 2014;2014:625180. doi: 10.1155/2014/625180. Epub 2014 Jul 16.
PubMed 25132734Kupeli I, Salcan S, Kuzucu M, Kuyrukluyildiz U. Can endocan be a new biomarker in ventilator-associated pneumonia? Kaohsiung J Med Sci. 2018 Dec;34(12):689-694. doi: 10.1016/j.kjms.2018.07.002. Epub 2018 Aug 9.
PubMed 30527203
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endocan; Can be a New Biomarker in Ventilator-associated Pneumonia?
- ClinicalTrials.gov ID
- NCT02916277
- Acronym / sponsor ID
- ERZINCAN UNIVERSITY 3
- Conditions
- Serial Endocan Measurements
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Erzincan UniversityUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 27 Sep 2016 (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.
In this study; in patients undergoing mechanical ventilation, making the day series Endocan measurements during the first 5 day to look at whether there is a relationship between the levels of VAP with Endocan. This relationship, if any, aimed to investigate whether correlated with clinical and laboratory findings [presence of fever, pathological lung X-ray, the number of white blood cells (WBC), procalcitonin (PCT), C-reactive protein (CRP)] .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients whether intubated and connected to a mechanical ventilator
Key inclusion criteria (2 listed)
- over 18 age
- Patients whether intubated and connected to a mechanical ventilator
Key exclusion criteria (7 listed)
- patients intubated due to lung problems such as COPD, asthma, pulmonary embolism , etc.
- Patients with brain tumors
- patients with acute and chronic renal failure
- Patients with hypertension
- Patients with previously diagnosed infection
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 |
|---|---|---|
| endocanto look series Endocan level for 5 days in intubated patients | Biological | – |
Primary outcome
relationship between the level of Endocan and development of VAP
Time frame: 9 month
1 secondary outcome
correlation with the level of Endocan and clinical and laboratory findings
Time frame: 9 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2016.
- Background: PubMed 10766680Fagon JY, Chastre J, Wolff M, Gervais C, Parer-Aubas S, Stephan F, Similowski T, Mercat A, Diehl JL, Sollet JP, Tenaillon A. Invasive and noninvasive strategies for management of suspected ventilator-associated pneumonia. A randomized trial. Ann Intern Med. 2000 Apr 18;132(8):621-30. doi: 10.7326/0003-4819-132-8-200004180-00004.
- Background: PubMed 11294706Mayhall CG. Ventilator-associated pneumonia or not? Contemporary diagnosis. Emerg Infect Dis. 2001 Mar-Apr;7(2):200-4. doi: 10.3201/eid0702.010209.
- Background: PubMed 14749453Gibot S, Cravoisy A, Levy B, Bene MC, Faure G, Bollaert PE. Soluble triggering receptor expressed on myeloid cells and the diagnosis of pneumonia. N Engl J Med. 2004 Jan 29;350(5):451-8. doi: 10.1056/NEJMoa031544.
- Background: PubMed 11590178Bechard D, Gentina T, Delehedde M, Scherpereel A, Lyon M, Aumercier M, Vazeux R, Richet C, Degand P, Jude B, Janin A, Fernig DG, Tonnel AB, Lassalle P. Endocan is a novel chondroitin sulfate/dermatan sulfate proteoglycan that promotes hepatocyte growth factor/scatter factor mitogenic activity. J Biol Chem. 2001 Dec 21;276(51):48341-9. doi: 10.1074/jbc.M108395200. Epub 2001 Oct 5.
- Background: PubMed 11025405Bechard D, Meignin V, Scherpereel A, Oudin S, Kervoaze G, Bertheau P, Janin A, Tonnel A, Lassalle P. Characterization of the secreted form of endothelial-cell-specific molecule 1 by specific monoclonal antibodies. J Vasc Res. 2000 Sep-Oct;37(5):417-25. doi: 10.1159/000025758.
- Results publication: PubMed 18421435Luyt CE, Combes A, Reynaud C, Hekimian G, Nieszkowska A, Tonnellier M, Aubry A, Trouillet JL, Bernard M, Chastre J. Usefulness of procalcitonin for the diagnosis of ventilator-associated pneumonia. Intensive Care Med. 2008 Aug;34(8):1434-40. doi: 10.1007/s00134-008-1112-x. Epub 2008 Apr 18.
- Results publication: PubMed 18482918Linssen CF, Bekers O, Drent M, Jacobs JA. C-reactive protein and procalcitonin concentrations in bronchoalveolar lavage fluid as a predictor of ventilator-associated pneumonia. Ann Clin Biochem. 2008 May;45(Pt 3):293-8. doi: 10.1258/acb.2007.007133.
- Results publication: PubMed 11215277Flanagan PG, Jackson SK, Findlay G. Diagnosis of gram negative, ventilator associated pneumonia by assaying endotoxin in bronchial lavage fluid. J Clin Pathol. 2001 Feb;54(2):107-10. doi: 10.1136/jcp.54.2.107.
- Results publication: PubMed 7886642el-Ebiary M, Torres A, Gonzalez J, Martos A, Puig de la Bellacasa J, Ferrer M, Rodriguez-Roisin R. Use of elastin fibre detection in the diagnosis of ventilator associated pneumonia. Thorax. 1995 Jan;50(1):14-7. doi: 10.1136/thx.50.1.14.
- Results publication: PubMed 8702785Lassalle P, Molet S, Janin A, Heyden JV, Tavernier J, Fiers W, Devos R, Tonnel AB. ESM-1 is a novel human endothelial cell-specific molecule expressed in lung and regulated by cytokines. J Biol Chem. 1996 Aug 23;271(34):20458-64. doi: 10.1074/jbc.271.34.20458.
- Results publication: PubMed 25132734Tang L, Zhao Y, Wang D, Deng W, Li C, Li Q, Huang S, Shu C. Endocan levels in peripheral blood predict outcomes of acute respiratory distress syndrome. Mediators Inflamm. 2014;2014:625180. doi: 10.1155/2014/625180. Epub 2014 Jul 16.
- Derived from this study: PubMed 30527203Kupeli I, Salcan S, Kuzucu M, Kuyrukluyildiz U. Can endocan be a new biomarker in ventilator-associated pneumonia? Kaohsiung J Med Sci. 2018 Dec;34(12):689-694. doi: 10.1016/j.kjms.2018.07.002. Epub 2018 Aug 9.
- Individual participant dataSharing planned: No
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.
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 Serial Endocan Measurements, run by Erzincan University at 1 site in Turkey (Türkiye).
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 2 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 27 Sep 2016. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ILKE KUPELI (+905555485632, ilkeser2004@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
relationship between the level of Endocan and development of VAP (time frame: 9 month). 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 NCT02916277, which also lists 12 linked publications.
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 27 Sep 2016.