- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT02589431
Comparison of Total, Salivary and Calculated Free Cortisol Levels in Patients With Severe Sepsis
Background: The purpose of the present study was to compare serum total cortisol (STC), salivary cortisol (SaC) and calculated free cortisol (cFC) levels at the baseline and after the ACTH stimulation test, in patients with severe sepsis (SS) and to determine the suitability of SaC and cFC levels instead of STC for the diagnosis of adrenal insufficiency in patients with SS.
Methods: Thirty patients with SS (15 men, and 15 women) were compared with 16 healthy controls. Low dose ACTH stimulation test (1 µg) was performed on the first, 7th and 28th days of diagnosis of SS. STC and SaC levels were measured during ACTH stimulation test.
Přehled studie
Postavení
Podmínky
Detailní popis
More than 90% of circulating cortisol is predominantly bound to cortisol binding globulin (CBG), but also albumin. Thus, in the presence of both hypoalbuminemia and decreased CBG levels, the ratio of bound to free cortisol levels can be altered. In this situation, measurement of FC becomes more important. Direct FC measurement is time consuming and non-automated. Thus, some indirect methods to determine FC levels had been introduced. The Coolens' method may be practical to determine FC, it estimates FC levels from STC and CBG levels. In patients with CI, the synthesis of CBG and albumin is reduced leading to overestimation of adrenal insufficiency if we only use STC levels. Since some studies demonstrated that salivary cortisol (SaC) reflect free or unbound plasma cortisol levels, this method is used more often in clinical studies. STC and SaC levels at baseline and after ACTH stimulation had been used in some studies in patients with critical illness.
The aim of the present study was to compare STC, SaC and calculated free cortisol (cFC) levels at baseline and after the ACTH stimulation test in patients with SS and determine the suitability of SaC and cFC levels instead of STC for the diagnosis of adrenal insufficiency in patients with SS. And secondary aims of this study was to compare these parameters in patients with SS with healthy controls and check their effects on survival status of the patients.
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
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Kayseri, Krocan, 38030
- Erciyes University Medical School Department of Endocrinology
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
Inclusion Criteria:
- Patients with severe sepsis.
Exclusion Criteria:
- Diabetes Mellitus,
- Pregnancy, and
- Use of glucocorticoids of any kind.
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
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Řízení
Zdravé subjekty
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Patients with severe sepsis
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Total Salivary and Calculated Free Cortisol Levels In Patients With Severe Sepsis
Časové okno: 24 months
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Survival
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24 months
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Spolupracovníci a vyšetřovatelé
Sponzor
Publikace a užitečné odkazy
Obecné publikace
- Deutschbein T, Unger N, Mann K, Petersenn S. Diagnosis of secondary adrenal insufficiency: unstimulated early morning cortisol in saliva and serum in comparison with the insulin tolerance test. Horm Metab Res. 2009 Nov;41(11):834-9. doi: 10.1055/s-0029-1225630. Epub 2009 Jul 7.
- Cooper MS, Stewart PM. Corticosteroid insufficiency in acutely ill patients. N Engl J Med. 2003 Feb 20;348(8):727-34. doi: 10.1056/NEJMra020529. No abstract available.
- Marik PE, Pastores SM, Annane D, Meduri GU, Sprung CL, Arlt W, Keh D, Briegel J, Beishuizen A, Dimopoulou I, Tsagarakis S, Singer M, Chrousos GP, Zaloga G, Bokhari F, Vogeser M; American College of Critical Care Medicine. Recommendations for the diagnosis and management of corticosteroid insufficiency in critically ill adult patients: consensus statements from an international task force by the American College of Critical Care Medicine. Crit Care Med. 2008 Jun;36(6):1937-49. doi: 10.1097/CCM.0b013e31817603ba.
- Hamrahian AH, Oseni TS, Arafah BM. Measurements of serum free cortisol in critically ill patients. N Engl J Med. 2004 Apr 15;350(16):1629-38. doi: 10.1056/NEJMoa020266.
- Annane D, Bellissant E. Prognostic value of cortisol response in septic shock. JAMA. 2000 Jul 19;284(3):308-9. No abstract available.
- Annane D, Maxime V, Ibrahim F, Alvarez JC, Abe E, Boudou P. Diagnosis of adrenal insufficiency in severe sepsis and septic shock. Am J Respir Crit Care Med. 2006 Dec 15;174(12):1319-26. doi: 10.1164/rccm.200509-1369OC. Epub 2006 Sep 14.
- Dickstein G. High-dose and low-dose cosyntropin stimulation tests for diagnosis of adrenal insufficiency. Ann Intern Med. 2004 Feb 17;140(4):312-3; author reply 313-4. doi: 10.7326/0003-4819-140-4-200402170-00026. No abstract available.
- Coolens JL, Van Baelen H, Heyns W. Clinical use of unbound plasma cortisol as calculated from total cortisol and corticosteroid-binding globulin. J Steroid Biochem. 1987 Feb;26(2):197-202. doi: 10.1016/0022-4731(87)90071-9.
- Gozansky WS, Lynn JS, Laudenslager ML, Kohrt WM. Salivary cortisol determined by enzyme immunoassay is preferable to serum total cortisol for assessment of dynamic hypothalamic--pituitary--adrenal axis activity. Clin Endocrinol (Oxf). 2005 Sep;63(3):336-41. doi: 10.1111/j.1365-2265.2005.02349.x.
- Elbuken G, Karaca Z, Tanriverdi F, Unluhizarci K, Sungur M, Doganay M, Kelestimur F. Comparison of total, salivary and calculated free cortisol levels in patients with severe sepsis. J Intensive Care. 2016 Jan 8;4:3. doi: 10.1186/s40560-015-0125-0. eCollection 2016.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- TST-10-2929
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