| CTRI Number |
CTRI/2017/11/010458 [Registered on: 10/11/2017] Trial Registered Retrospectively |
| Last Modified On: |
10/11/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Prediction of death in patients with dessiminated infection, based on measurements and characteristics of blood cells |
|
Scientific Title of Study
|
Epidemiology and prognostic utility of cellular components of hematological system in sepsis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Harsha Sinha |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of anaesthesia, pain medicine and critical care, office room no 5011, 5th floor, AIIMS, Ansari Nagar
South
DELHI
110029
India |
| Phone |
9535616756 |
| Fax |
|
| Email |
harshasinh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dalim Kumar Baidya |
| Designation |
Assistant professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of anaesthesia, pain medicine and critical care, Office room no 5011, 5th floor, AIIMS, Ansari nagar
South
DELHI
110029
India |
| Phone |
9871568534 |
| Fax |
|
| Email |
dalimkumar.ab8@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Harsha Sinha |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of anaesthesia, pain medicine and critical care, office room no 5011, 5th floor ,AIIMS, Ansari nagar
South
DELHI
110029
India |
| Phone |
9535616756 |
| Fax |
|
| Email |
harshasinh@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS,Ansari Nagar, Aurobindo Marg, New Delhi 110029 |
|
|
Primary Sponsor
|
| Name |
AIIMS |
| Address |
Ansari Nagar, Aurobindo Marg, New Delhi 110029 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Dalim Kumar Baidya |
Room No 5011, Anaesthesia office, AIIMS, New Delhi |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Harsha Sinha |
AIIMS |
AB8 ICU,Department of anaesthesia,pain medicine and critical care,
eighth floor
TC2 ICU, second floor,JPNATC
South
DELHI |
9535616756
harshasinh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee For Post Graduate Research, AIIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
sepsis patients in ICU, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1 Sepsis patients admitted in ICU
2 Within 24 hours of diagnosis of sepsis
3 Age 18-65 years
|
|
| ExclusionCriteria |
| Details |
1. Patients’/ their relatives’ refusal to consent for study. 2. Preexisting hematological disorder/ malignancy.
3. Previous history of sepsis
4. History of ICU stay within last 6 months
5. Any chronic disease, which can impair hematological system
6. History of blood transfusion in the last two weeks before ICU admission or within first three days of ICU admission.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To identify if parameters derived from cellular components of hematological system i.e.,
Hematocrit, red cell distribution width, evidence of hemolysis in peripheral blood smear, immature granulocytes,thrombocytopenia, immature platelet fraction and platelet distribution width,
measured at day one of sepsis and after 72 hours (initial value and change over 72 hours)
can predict 28-day mortality in adult patients with sepsis admitted to intensive care unit. |
28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Increased length of ICU stay,
Increased number of days on mechanical ventilation,
Increased requirement of vasopressor support and
Increased requirement of renal replacement therapy in patients admitted to ICU with sepsis.
|
28 days |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
25/02/2017 |
| 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="11"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Primary objective: To identify if parameters derived from cellular components of hematological system (hematocrit, red cell distribution width, evidence of hemolysis in peripheral blood smear,thrombocytopenia, immature granulocytes, immature platelet fraction and platelet distribution width) measured on day 1 of sepsis and after 72 hrs (initial value and change over 72 hrs) can predict 28 day mortality in adult patients with sepsis admitted to ICU.
Hypothesis: A composite index derived from hematological system can improve the prognostic utility of SOFA score (Sequential organ failure assessment ) in sepsis patients.
Study protocol: Adult patients fulfilling inclusion criteria will be recruited to study in the 24 hrs of diagnosis of sepsis. Their blood samples will be sent to the hospitals’s hematology lab to evaluate the study parameters on day 1 and again after 72 hrs. All the patients will be followed up till hospital discharge or death ,whichever is earlier. After data compilation is complete, the entire study population will be divided into two groups based on 28 day hospital mortality : survivors and non survivors. The difference in the study parameters between these two groups will be calculated by applying appropriate statistical methods. |