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临床试验/CTRI/2024/03/064782
CTRI/2024/03/064782尚未招募不适用

Evaluation of Immature Granulocyte Count as early marker of sepsis: a Prospective Observational study

Dr Shabnam Ahmeda1 个研究点 分布在 1 个国家目标入组 91 人开始时间: 2024年4月5日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
91
试验地点
1
主要终点
To evaluate Immature Granulocyte Count and Immature Granulocyte percentage as one of the early biomarker of sepsis

研究概览

简要总结

INTRODUCTION : • Sepsis is a life threatening condition that can lead to shock , severe organ failure and even death. The mortality of severe sepsis in India reaches up to 65.2%(1). • It is the result of excessive activation of host defence mechanism to the invasion of normally sterile tissue ,fluid, or body cavity by pathogenic microorganism or to their toxic product presence in the circulation .i.e the body’s response to systemic infection rather than the direct effect of the microorganism(2,3). • Early detecÆŸon of infection, sepsis and multiorgan dysfunction is the key for successful management(1). • The Surviving Sepsis Campaign, recommend that antibiotic should be administered immediately, ideally within 1 hr of recognition for adult with possible septic shock or a high likelihood for sepsis(1,4). • Blood cultures are used to identify pathogens but the major disadvantage is the relatively long incubation period before establishing the diagnosis(1,5).False negative blood culture result might be due to prior treatment with antimicrobials, inappropriate culturing conditions for fastidious organisms, insufficient quantity of blood. False posivve blood culture result might be due to errors in collection or processing of the samples.(5) • Hence diagnosing an infection rapidly and accurately in very early SIRS is both challenging and vital for early induction of appropriate therapy. • Biomarker such as Procalcitonin(PCT),C-reactive protein(CRP),lactic acid(Lac),interleukin-6 (IL-6) are predictive biomarker(1,6).But are relatively of high cost (1). • Sepsis is characterised by marked increase in neutrophil production by bone marrow and recruitment of immature neutrophil i.e circulating non-segmented neutrophil (band cell) and immature granulocyte, into the circulation. This is usually referred to as “leÅŒ shiŌ”.(3,7) • Immature Granulocyte fraction of the neutrophil include promyelocyte, myelocyte, metamyelocyte which have better morphological definition.(1,7) Immature Granulocyte fraction is believed to be the first • reaction of the bone marrow to an infection and increased Immature granulocyte in peripheral blood indicate an enhanced bone marrow activity.(1,7,8) • According to certain studies, the immature granulocyte is a useful marker for to differentiate patients with sepsis from those with non infectious inflammation.(1,8) • Immature Granulocyte count(IG#) and Immature Granulocyte percentage(IG%) can be estimated as early predictor of sepsis. The modern automated cell counting machine allows simple, fast and inexpensive quantification of IG.(7,8)

METHOD AND MATERIALS : • After approval by the institutional ethical commttee, the study will be conducted under the Department of Anaesthesiology and Critical Care ,GMCH . The study will be carried on patients with clinical suspicion of infection admitted to the General ICU (GICU) under the Department of Anaesthesiology and Critical Care, in the 64 – bedded ICU complex of Gauhati Medical College and Hospital.

REFERENCES : • (1) Bhansaly P, Mehta S, Sharma N, Gupta E, Mehta S, Gupta S. EvaluaƟon of Immature Granulocyte Count as the Earliest Biomarker for Sepsis. Indian J Crit Care Med. 2022 Feb;26(2):216-223. doi: 10.5005/jpjournals-10071-23920. • (2) Cinel I, Dellinger RP. Advances in pathogenesis and management of sepsis. Curr Opin Infect Dis. 2007 Aug;20(4):345-52. doi: 10.1097/QCO.0b013e32818be70a. • (3) Ayres LS, Sgnaolin V, Munhoz TP. Immature granulocytes index as early marker of sepsis. Int J Lab Hematol. 2019 Jun;41(3):392-396. doi: 10.1111/ijlh.12990. Epub 2019 Feb 26. • (4) Evans, Laura1; Rhodes, Andrew2; Alhazzani, Waleed3; Antonelli, Massimo4; Coopersmith, Craig M.5; French, Craig6; Machado, Flávia R.7; Mcintyre, Lauralyn8; Ostermann, Marlies9; PrescoƩ, Hallie C.10; Schorr, Christa11; Simpson, Steven12; Wiersinga, W. Joost13; Alshamsi, Fayez14; Angus, Derek C.15; Arabi, Yaseen16; Azevedo, Luciano17; Beale, Richard18; Beilman, Gregory19; Belley-Cote, Emilie20; Burry, Lisa21; Cecconi, Maurizio22; CentofanƟ, John23; Coz Yataco, Angel24; De Waele, Jan25; Dellinger, R. Phillip26; Doi, Kent27; Du, Bin28; Estenssoro, Elisa29; Ferrer, Ricard30; Gomersall, Charles31; Hodgson, Carol32; Hylander Møller, Morten33; Iwashyna, Theodore34; Jacob, Shevin35; Kleinpell, Ruth36; Klompas, Michael37; Koh, Younsuck38; Kumar, Anand39; Kwizera, Arthur40; Lobo, Suzana41; Masur, Henry42; McGloughlin, Steven43; Mehta, Sangeeta44; Mehta, YaƟn45; Mer, Mervyn46; Nunnally, Mark47; Oczkowski, Simon48; Osborn, Tiffany49; Papathanassoglou, Elizabeth50; Perner, Anders51; Puskarich, Michael52; Roberts, Jason53; Schweickert, William54; Seckel, Maureen55; Sevransky, Jonathan56; Sprung, Charles L.57; Welte, Tobias58; Zimmerman, Janice59; Levy, Mitchell60. Surviving Sepsis Campaign: InternaƟonal Guidelines for Management of Sepsis and SepƟc Shock 2021. CriƟcal Care Medicine 49(11):p e1063-e1143, November 2021. • (5)Ansari-Lari MA, Kickler TS, Borowitz MJ. Immature granulocyte measurement using the Sysmex XE-2100. RelaƟonship to infecƟon and sepsis. Am J Clin Pathol. 2003 Nov;120(5):795-9. doi: 10.1309/LT30- BV9U-JJV9-CFHQ. • (6)Nierhaus, A., KlaƩe, S., Linssen, J. et al. RevisiƟng the white blood cell count: immature granulocytes count as a diagnosƟc marker to discriminate between SIRS and sepsis - a prospecƟve, observaƟonal study. BMC Immunol 14, 8 (2013). hƩps://doi.org/10.1186/1471-2172- 14-8 • (7) van der Geest PJ, Mohseni M, Brouwer R, van der Hoven B, Steyerberg EW, Groeneveld AB. Immature granulocytes predict microbial infecƟon and its adverse sequelae in the intensive care unit. J Crit Care. 2014 Aug;29(4):523-7. doi: 10.1016/j.jcrc.2014.03.033. Epub 2014 Apr 5. • (8) Georgakopoulou VE, Makrodimitri S, Triantafyllou M, Samara S, Voutsinas PM, Anastasopoulou A, Papageorgiou CV, Spandidos DA, Gkoufa A, Papalexis P, Xenou E, Chelidonis G, Sklapani P, Trakas N, Sipsas NV. Immature granulocytes: InnovaƟve biomarker for SARS-CoV-2 infecƟon. Mol Med Rep. 2022 Jul;26(1):217. doi: 10.3892/mmr.2022.12733. Epub 2022 May 13.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Patients admitted to ICU with a clinical suspicion of infection based on SIRS criteria.

排除标准

  • Patients with blood malignancy
  • Patients with immunodeficiency disease
  • Patients those being treated with immunosupressive medication
  • Patients who develop sepsis and expired within 24 hours of beginning of study
  • Pregnant patients.

结局指标

主要结局

To evaluate Immature Granulocyte Count and Immature Granulocyte percentage as one of the early biomarker of sepsis

时间窗: Will be done on Day 0 of admission as baseline and on days 1, 3 after admisssion

次要结局

  • To compare Immature Granulocyte Count and Immature Granulocyte percentage with SOFA Score in predicting severity of sepsis(Will be done Days 1 and 3 of admission)

研究者

发起方
Dr Shabnam Ahmeda
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Shabnam Ahmeda

Gauhati Medical College and Hospital

研究点 (1)

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