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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02916277
Other study ID # ERZINCAN UNIVERSITY 3
Secondary ID
Status Recruiting
Phase N/A
First received September 24, 2016
Last updated September 24, 2016
Start date August 2016
Est. completion date March 2017

Study information

Verified date September 2016
Source Erzincan University
Contact ILKE KUPELI
Phone +905555485632
Email ilkeser2004@gmail.com
Is FDA regulated No
Health authority Turkey: Ethics Committee
Study type Observational [Patient Registry]

Clinical 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. 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)] .


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date March 2017
Est. primary completion date February 2017
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- over 18 age

- Patients whether intubated and connected to a mechanical ventilator

Exclusion Criteria:

- 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Intervention

Biological:
endocan
to look series Endocan level for 5 days in intubated patients

Locations

Country Name City State
Turkey Erzincan University Erzincan

Sponsors (1)

Lead Sponsor Collaborator
Erzincan University

Country where clinical trial is conducted

Turkey, 

References & Publications (11)

Béchard 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. Epub 2001 Oct 5. — View Citation

Bechard 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. — View Citation

el-Ebiary M, Torres A, González 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. — View Citation

Fagon JY, Chastre J, Wolff M, Gervais C, Parer-Aubas S, Stéphan 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. — View Citation

Flanagan 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. — View Citation

Gibot 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. — View Citation

Lassalle 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. — View Citation

Linssen 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. — View Citation

Luyt 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/ — View Citation

Mayhall CG. Ventilator-associated pneumonia or not? Contemporary diagnosis. Emerg Infect Dis. 2001 Mar-Apr;7(2):200-4. Review. — View Citation

Tang 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. — View Citation

* Note: There are 11 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary relationship between the level of Endocan and development of VAP 9 month No
Secondary correlation with the level of Endocan and clinical and laboratory findings 9 month No