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CTRI Number  CTRI/2024/03/064782 [Registered on: 27/03/2024] Trial Registered Prospectively
Last Modified On: 26/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A clinical study to see how good is Immature Granulocyte Count (a blood test report) for early prediction of severe disease in ICU patients that can lead to Sepsis( a severe form of life threatening illness) 
Scientific Title of Study   Evaluation of Immature Granulocyte Count as early marker of sepsis: a Prospective Observational study  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shabnam Ahmeda 
Designation  Post Graduate Trainee 
Affiliation  Gauhati Medical College and Hospital 
Address  Department of Anaesthesiology and Critical Care Gauhati Medical College and Hospital Bhangagarh Guwahati Kamrup Metro-781032 Assam
Department of Anaesthesiology and Critical Care Gauhati Medical College and Hospital Bhangagarh Guwahati Kamrup Metro-781032 Assam
Kamrup
ASSAM
781032
India 
Phone  9101659007  
Fax    
Email  shabnamahmeda2014@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Hiranya Kumar Saharia 
Designation  Associate Professor 
Affiliation  Gauhati Medical College and Hospital 
Address  Department of Anaesthesiology and Critical Care Gauhati Medical College and Hospital Bhangagarh Guwahati Kamrup Metro-781032 Assam
Bhangagarh Kamrup Metro Guwahati-781032
Kamrup
ASSAM
781032
India 
Phone  9435087643  
Fax    
Email  sahariahiranya@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Shabnam Ahmeda 
Designation  Post Graduate Trainee 
Affiliation  Gauhati Medical College and Hospital 
Address  Department of Anaesthesiology and Critical Care Gauhati Medical College and Hospital Bhangagarh Guwahati Kamrup Metro-781032 Assam
Bhangagarh Kamrup Metro Guwahati-781032
Kamrup
ASSAM
781032
India 
Phone  9101659007  
Fax    
Email  shabnamahmeda2014@gmail.com  
 
Source of Monetary or Material Support  
Gauhati Medical College and Hospital Bhangagarh Guwahati Kamrup Metro-781032 Assam 
 
Primary Sponsor  
Name  Dr Shabnam Ahmeda 
Address  Department of Anaesthesiology and Critical Care Gauhati Medical College and Hospital Bhangagarh Guwahati Kamrup Metro-781032 Assam 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shabnam Ahmeda  Gauhati Medical College and Hospital  Department of Anaesthesiology and Critical Care GMCH Bhangagarh Kamrup Metro Guwahati- 781032 Assam
Kamrup
ASSAM 		 9101659007

shabnamahmeda2014@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITEE, GAUHATI MEDICAL COLLEGE AND HOSPITAL GUWAHATI  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R652||Severe sepsis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients admitted to ICU with a clinical suspicion of infection based on SIRS criteria 
 
ExclusionCriteria 
Details  1. Patients with blood malignancy
2. Patients with immunodeficiency disease
3. Patients those being treated with immunosupressive medication
4. Patients who develop sepsis and expired within 24 hours of beginning of study
5. Pregnant patients 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate Immature Granulocyte Count and Immature Granulocyte percentage as one of the early biomarker of sepsis  Will be done on Day 0 of admission as baseline and on days 1, 3 after admisssion 
 
Secondary Outcome  
Outcome  TimePoints 
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 
 
Target Sample Size   Total Sample Size="91"
Sample Size from India="91" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   05/04/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   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. EvaluaÆŸon 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; PrescoÆ©, 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; CentofanÆŸ, 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, YaÆŸn45; 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: InternaÆŸonal Guidelines for Management of Sepsis and SepÆŸc Shock 2021. CriÆŸcal 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. RelaÆŸonship to infecÆŸon and sepsis. Am J Clin Pathol. 2003 Nov;120(5):795-9. doi: 10.1309/LT30- BV9U-JJV9-CFHQ. • (6)Nierhaus, A., KlaÆ©e, S., Linssen, J. et al. RevisiÆŸng the white blood cell count: immature granulocytes count as a diagnosÆŸc marker to discriminate between SIRS and sepsis - a prospecÆŸve, observaÆŸonal study. BMC Immunol 14, 8 (2013). hÆ©ps://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 infecÆŸon 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: InnovaÆŸve biomarker for SARS-CoV-2 infecÆŸon. Mol Med Rep. 2022 Jul;26(1):217. doi: 10.3892/mmr.2022.12733. Epub 2022 May 13. 
 
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