RAJIVGANDHIUNIVERSITY OF HEALTH SCIENCES OF KARNATAKA

BANGALORE,KARNATAKA

ANNEXURE – II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

1. /
Name of the Candidate
and Address
(in Block Letters) / DR.S.MAHABOOB FARHANA
D/O: S MAHABOOB PEERA,
CORRESPONDENT,
CRESCENT COLLEGE OFNURSING,
RAVINDRA NAGAR,
KADAPA, 516002,
ANDHRA PRADESH
2. /
Name of the Institution
/ J.J.M.MEDICALCOLLEGE,
DAVANAGERE.
KARNATAKA.
3. / Course of the Study and Subject / M.D. IN PAEDIATRICS
4. / Date of Admission to Course / 06th SEPTEMBER 2013
5. /
Title of the Topic
/ “COMPARISION OF SERUM
C-REACTIVE PROTIEN (CRP) AND SERUM PROCALCITONIN (PCT) AS A DIAGNOSTIC AND PROGNOSTIC MARKER OF SEPSIS IN CHILDREN ADMITTED TO PICU”
6. / BRIEF RESUME OF THE INTENDED WORK
6.1 Need for the Study:
Sepsis is the most common cause of mortality in children world wide. The incidence of septic shock is increasing world over, with a 10 fold increase in the past 20 years. Any delay in the recognition and treatment significantly increase the risk of mortality and morbidity.1
The diagnosis of bacterial infection in critically ill children still remains difficult. Sepsis suffers from a lack of specific clinical signs and symptoms and it may be difficult to distinguish from other non infective conditions that can generate an inflammatory response. Conventional clinical and laboratory parameters including gold standard blood culture is time consuming and many lack sensitivity and specificity.
The concept of early detection serves as the foundation for the search for clinically viable indicators of severe sepsis and septic shock. In this context it was felt that there is a need to develop biomarkers in the field of sepsis in order to supplement clinical assessments and provide information on diagnostic, prognostic and therapeutic decision making.2
Over the years, dozens of biomarkers for sepsis and septic shock have been described in the literature. An ideal biomarker for bacterial infection should allow an early diagnosis, inform about the course and prognosis of the disease and facilitate therapeutic interventions.
The traditionally and most commonly used laboratory biomarker in sepsis is C-reactive protein which lacks diagnostic specificity. The other pro inflammatory cytokines e.g TNF-α,IL-1β,IL-6 are increased briefly and intermittently during the course of disease. Off late procalcitonin is getting attention as a sepsis biomarker. Multiple studies have shown that procalcitonin levels are markedly higher in patients with sepsis than in healthy controls and in some studies it has been shown that it has got a better diagnostic ability than compared to other biomarkers especially C- reactive protein. Since the expression of serum procalcitonin as a diagnostic and prognostic marker has not been well studied in paediatric population of India, we are making an attempt to prove its efficacy as marker of sepsis in south Indian children admitted to paediatric intensive care unit.
6.2 Review of Literature:
In a study conducted by Mahua Sinha et al where 40 critically ill patients were studied, out of which 21 had clinically confirmed sepsis. Among these 21 patients,12 patients had serum procalcitonin 10ng/ml and 7 patients had a serum procalcitonin 2-10ng/ml and 3 patients with serum procalcitonin 0.5-2ng/ml and it was seen that in patients who had serum procalcitonin of >2ng/ml had statistically significant correlation with presence of sepsis.3 (P<0.0001).
In another study conducted by Bin Mathew et al, usefulness of procalcitonin in establishing an early diagnosis of sepsis in children was observed.150 children admitted to ICU with clinical features suggestive of septicemia were studied. Among them 63% of the children who were diagnosed with a bacterial etiology showed detectable blood procalcitonin levels with higher concentrations, while in the children who were diagnosed with a viral etiology, only 22.2 % had detectable procalcitonin levels, but in lower concentrations. Thus they confirmed in their study that the procalcitonin levels is a better marker for bacterial infections.4
In another study conducted by Christophe Clech et al, 62 patients in the septic shock group had a serum procalcitonin levels that were higher on day 1 than in those without septic shock(P<0.01). They also noticed that C-reactive protein failed to discriminate between these two groups. Further, the study showed that in patients who died because of sepsis, procalcitonin concentrations were significantly higher than in those who survived.5
In a study conducted by Simon L et al 64 patients of who had Systemic Inflammatory Response Syndrome (SIRS) were studied, of which 25 patients had bacterial etiology for SIRS and 39 nonbacterial. Procalcitonin levels were higher (> or = 2.5 ng/ml) in patients with bacterial infection when compared to those patients who had SIRS due to nonbacterial causes (P=0.01), thus indicating that higher procalcitonin levels increased the likelihood of picking bacterial infections. Simultaneously done C-reactive protein levels in these patients failed to differentiate the two groups .Thus it was concluded that procalcitonin is better than C-reactive protein for differentiating bacterial from non bacterial SIRS.6
6.3 Aims and Objective of the study:
  1. To evaluate serum Procalcitonin levels as a marker of sepsis in children admitted to paediatric intensive care unit.
  2. To evaluate prognostic value of serum Procalcitonin in children with sepsis.
  3. To compare the efficacy of serum Procalcitonin and serum C-reactive protein levels in the diagnosis of sepsis in children.

7. / MATERIALS AND METHODS
7.1 Source of Data :
All children who are admitted with clinical features of sepsis and septic shock in Chigateri district hospital Davangere and Bapuji Child Health Institute and Research center Davangere, Karnataka, the hospitals that are attached to J J M Medical College Davangere.
7.2 Method of Collection of Data:
Sample size: Initially a minimum of fifty children admitted to our PICU are intended to be taken up. These subjects will be selected consecutively during study period as and when they are presented with following inclusion and exclusion criteria.
Study Design: Prospective Observational study
Inclusion Criteria: -
  1. All children more than 1 month of age admitted to PICU with clinical features suggestive SIRS, sepsis and septic shock will be considered.
  2. Patients giving written informed consent.
Exclusion Criteria:-
  1. Children who are admitted for burns, trauma.
  2. Post operative patients.
  3. Children who had shock attributable to other causes like cardiogenic or hypovolemic or obstructive)
Methodology-
Children admitted to the PICUS’s of both the hospitals fulfilling the inclusion / exclusion criteria will be taken into study after obtaining written informed consent. Demographic data, history, clinical examination and details of investigations will be recorded in the study performa. Serum procalcitonin and serum C-reactive protein assay will be done by commercially available ELISA kits. The first sample will be collected from the test group at the time of admission, a second sample at 24 hours and the third sample will be collected at 96 hours after admission. Serum Procalcitonin value of >0.5ng/ml will be taken as the cut off value.
Duration of study: 2 years
Statistical Analysis:
The data in this study will be assessed using chi-square test. Diagnostic validity tests will be performed to asses the diagnostic value of procalcitonin as a biomarker for the diagnosis and prognosis of sepsis.
7.3 Does the study require any investigations or interventions to be conducted on patients or other humans or animals? If so, please describe briefly.
Yes
  1. Complete blood count with Erythrocyte sedimentation rate
  2. Serum levels of C reactive protein, procalcitonin and lactate levels will be estimated
  3. Renal Function tests.
  4. Liver function tests.
  5. Blood culture
  6. Urine routine examination and culture sensitivity
  7. Chest x ray.
  8. Peripheral smear for malarial parasite and IgM-Leptospira and dengue as and when indicated.
  9. Arterial Blood Gas analysis.
7.4 Has ethical clearance been obtained from your institution in case of 7.3?
Yes
8 / List of references:
1.Kutko MC, Calarco MP, Flaherty MB, et al. Mortality rates in pediatric septic shock with and without multiple organ system failure. Pediatr Crit Care Med 2003; 4(3): 333-7.
2.Stephen W Standage and Hector R Wong. Biomarkers of paediatric sepsis and septic shock. Expert Rev Anti Infect Ther. 2011 January ; 9(1): 71-79. doi:10.1586/eri.10.154.
3.Sinha M ,Desai S ,Mantri S and Kulkarni A; Procalcitonin as an adjunctive biomarker in sepsis. Indian J Anaesth 2011;55:266-70.
4.Bin Mathew, Dinesh Roy D, and T Vijaya Kumar.The Use of Procalcitonin as a Marker of Sepsis in Children.J Clin Diagn Res. 2013 February; 7(2): 305–307.
5.Christophe Clec'h, MD; Francoise Ferriere, MD; Philippe Karoubi, MD, et al.Diagnostic and prognostic value of procalcitonin in patients with septic shock. Care Med 2004 Vol. 32, No. 5.
6.Simon L, Saint-Louis P, Amre DK, Lacroix J, Gauvin F.Procalcitonin and C-reactive protein as markers of bacterial infection in critically ill children at onset of systemic inflammatory response syndrome.Pediatr Crit Care Med, 2008 Jul;9(4):407-13. doi: 10. 109/PCC. 0b013e31817285a6.
9. / Signature of Candidate / (Dr. S.MAHABOOB.FARHANA)
10. / Remarks of the Guide / THIS STUDY HELPS IN MAKING AN EARLY DIAGNOSIS OF SEPSIS AND MAY ALSO HELP US IN TAKING EARLY DECISIONS WHICH IS THE KEY IN THE TREATMENT OF SICK CHILDREN. (STARTING ANTIBIOTICS BEFORE CULTURE REPORT BECOME AVAILABLE)
11. / Name and Designation of
(in block letters)
11.1 Guide / Dr. MADHUS.PUJAR MD
ASSOCIATE PROFESSOR,
DEPARTMENT OF PEDIATRICS,
J.J.M.MEDICALCOLLEGE,
DAVANGERE– 577002
11.2 Signature
11.3 Co-Guide (if any)
11.4 Signature
11.5 Head of Department / DR. C. R. BANAPURMATH
M.D., DCH., M.N.A.M.S., F.I.A.P.,
PROFESSOR AND HEAD OF THE DEPARTMENT,
DEPARTMENT OF PEDIATRICS,
J.J.M.MEDICALCOLLEGE,
DAVANGERE.
11.6 Signature
12. / 12.1 Remarks of the
Chairman and Principal
12.2 Signature