Title of the project:  Serum Cortisol Levels in children with sepsis

Sponsor name:  NA

Principal Investigator:  DR Sharana Shree .P

Designation:  JR1 Department of Peadiatrics

Mobile number:  9986695334

Hospital:  Kasturba Hospital Manipal

Language: English

1. Introduction to the research study:  child is being invited to participate in this study / research / experiment because your child has Sepsis. This study involves the use of an (Biochemistry test) Serum cortisol levels. This biochemical test has been approved by the concerned authority and is being experimented in this study.

2. Purpose of the study: To study the serum cortisol levels in children with sepsis. To assess serum cortisol levels in children with sepsis at admission. To correlate serum cortisol levels with Paediatric Sequential Organ Failure Assessment (PSOFA) score at admission. To evaluate the correlation between serum cortisol levels and clinical outcomes, including severity of illness, sepsis and septic shock, response to therapy, and mortality

3. Who can take part:  

Inclusion criteria: Children aged 1 month to 18 years of age admitted with a clinical diagnosis of sepsis in the Department of Paediatrics, KMC Manipal.                                                 

Exclusion criteria: Children with Pre-existing condition associated with dysfunction of the hypothalamo–pituitary–adrenal  axis. Known endocrine disorders affecting cortisol metabolism. Any use of systemic corticosteroids during the 2 weeks preceding this episode. Patients with known primary immune deficiency disorders. Children receiving immunosuppressive therapy

4. Information about the study (as a whole):

• No. of patients expected to participate / sample size:148    

• Screening of patients using: Using the PSOFA score to make a clinical diagnosis of sepsis.        

• Grouping of patients into test drug/standard drug: NA  

• Dosage, duration. • Information concerning taping or filming (If applicable):NA

 • If case tissues or biological samples, are being retained for research, describe what will be done to the tissues. (Including disposal): Serum sample of 2ml to determine serum cortisol levels in Red vacutainer to the department of biochemistry at Kasturba hospital Manipal.

5. What will happen to the individual participant  during the study:

• How many visits to the hospital: 1 single visit

• At each visit what all information will be asked and given: Serum cortisol at first visit only in the presence of a clinical diagnosis of sepsis

• What physical examination will be done? What all lab tests will be done, including quantity of blood to be drawn etc. (Blood sample will be used only for the above tests and no other tests will be carried out): General physical examination, Anthropometry, Systemic examination of Cardiac, Respiratory, Per Abdomen and CNS examinations. Serum Cortisol Levels will be estimated using 2ML of venous blood collected in a Red vacutainer sent to department of Biochemistry. 

 • Giving of drugs.NA

 • Any questionnaire will be given. NA

• If this is a randomized trial, details of both arms of the trial must be explained. • State the amount of time required by the individual participant for each phase of the study, with a clear statement of the total duration of the study: NA

6. Role/responsibility of the individual participant in the study: • Provide accurate information whenever asked. • Inform the study doctor about any problems/side effects experienced during the study. • Follow the investigator’s instructions. • If you want to discontinue from the study, study doctor to be informed.

7. What are the risks?

Risk associated with drawing of blood sample: Hematoma at prick site, prolonged bleeding, infection at the prick site 

8. What are the potential benefits of participating in the study:  stay the same If your child takes part in this study your child may help other patients with A better understanding of cortisol dynamics in children with sepsis could aid in early risk stratification, potentially improve survival outcomes by contributing to the knowledge on the investigational biochemical test.

9. What are the alternative treatments available:  NA

10. Cost of participating in the study: This is an observational study and does not involve any treatment. Participation in this study does not involve any extra cost. Blood test are a part of standard of care

11. Compensation for injury: If a medical problem arises during this research study as a direct result of the study treatment, the study doctor will be responsible for making sure that proper medical care is provided to you. If your child suffers any physical/mental injury or illness as a direct result of the proper administration of the study drug to your child or of properly performed study procedures, sponsor will reimburse you for reasonable medical expenses that your child incurs to treat the injury or illness.

12. Confidentiality of information: Information from the study records including child’s name, address, medical records, results of tests, study results will be kept confidential and will be reviewed only by authorized personnel from the sponsor or their representative, Ethics Committee, or regulatory bodies.  The data will not be made available to another individual unless you specifically give permission in writing. Information and results from this study may be presented at meetings or published in journals without including your child’s name and personal identifications. No reference will be made in oral or written reports which could link the child to the study.

13. Voluntary participation: child’s participation in this study is voluntary; Gaurdian may decline your child’s participation at any time, and  need not give any reason for the same, and such withdrawal shall be without penalty and without loss of benefits to which child is otherwise entitled. If child withdraws from the study prior to its completion,  child will receive the usual standard of care for your child’s disease, and  child’s nonparticipation will not have any adverse effects on your child’s subsequent medical treatment or  child’s relationship with the treating physician. If  child withdraws from the study before data collection is completed, child’s data collected until child’s indicated withdrawal will be used in the study report. Sponsor or the investigator may stop the research or child’s participation in it at any time for some or other reason without child’s permission.