| CTRI Number |
CTRI/2018/08/015371 [Registered on: 17/08/2018] Trial Registered Prospectively |
| Last Modified On: |
10/08/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
PROSPECTIVE OBSERVATIONAL STUDY |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of two blood tests in predicting risk of death in patients with blood infection |
|
Scientific Title of Study
|
Comparison between lactate clearance and neutrophil lymphocyte count ratio as a predictor of mortality in patients with sepsis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SHIV AKSHAT |
| Designation |
SENIOR RESIDENT |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, CRITICAL CARE AND PAIN MEDICINE
AIIMS
ANSARI NAGAR
ANSARI NAGAR
NEW DELHI
South
DELHI
110029
India |
| Phone |
9654465389 |
| Fax |
|
| Email |
drshivakshat@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
PUNEET KHANNA |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES |
| Address |
ROOM NO. 5011
DEPARTMENT OF ANAESTHESIOLOGY, CRITICAL CARE AND PAIN MEDICINE
AIIMS
ANSARI NAGAR
ROOM NO. 5011
DEPARTMENT OF ANAESTHESIOLOGY, CRITICAL CARE AND CRITICAL CARE
TEACHING BLOCK
AIIMS
ANSARI NAGAR
South
DELHI
110029
India |
| Phone |
9873106516 |
| Fax |
|
| Email |
k.punit@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
SHIV AKSHAT |
| Designation |
SENIOR RESIDENT |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, CRITICAL CARE AND PAIN MEDICINE
AIIMS
ANSARI NAGAR
ANSARI NAGAR
NEW DELHI
South
DELHI
110029
India |
| Phone |
9654465389 |
| Fax |
|
| Email |
drshivakshat@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES |
| Address |
AIIMS ANSARI NAGAR NEW DELHI |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| SHIV AKSHAT |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES |
ROOM NO. 5011
DEPARTMENT OF ANAESTHESIOLOGY , PAIN MEDICINE AND CRITICAL CARE
TEACHING BLOCK
AIIMS
ANSARI NAGAR
South
DELHI |
9654465389
drshivakshat@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE FOR POSTGRADUATE RESEARCH, ALL INDIA INSTITUTE OF MEDICAL SCIENCES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A419||Sepsis, unspecified organism, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.PATIENTS WITH PRESUMED BACTERIAL SEPSIS (DEFINED AS POSITIVE qSOFA OR INCREASE IN SOFA SCORE BY TWO OR MORE POINTS) AND INITIAL LACTATE VALUE GREATER THAN 2 mmol PER LITRE |
|
| ExclusionCriteria |
| Details |
1. PATIENTS WITH ESRD
2. PATIENTS ON HEMODIALYSIS AKI ACUTE CEREBROVASCULAR ACCIDENT ACUTE CORONARY SYNDROME ACUTE PULMONARY OEDEMA STATUS ASTHMATICUS SEIZURE TRAUMA UNCONTROLLED HAEMORRHAGE THOSE RECEIVING CORTICOSTEROID |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| 28 DAYS MORTALITY DIFFERENCE BETWEEN LACTATE CLEARANCE GREATER THAN 20 PERCENT OF BASELINE VERSUS LESS THAN 20 PERCENT OF BASELINE AND BETWEEN NLR MORE THAN 7 VERSUS LESS THAN 7 |
28 DAYS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| CORRELATION BETWEEN LACTATE CLEARANCE AND NLR |
28 DAYS |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
24/08/2018 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NONE YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
IN ALL PATIENTS MEETING THE INCLUSION CRITERIA A BLOOD SAMPLE WILL BE DRAWN AND INITIAL SERUM LACTATE AS WELL AS NEUTOPHIL LYMPHOCYTE COUNT RATIO AT THE TIME OF PRESENTATION WILL BE CALCULATED. AT 6 HOURS INTERVAL OF PRESENTATION SERUM LACTATE VALUE WILL BE MEASURED . LACTATE CLEARANCE WILL BE CALCULATED . THE ABILITY OF LACTATE CLEARANCE AND NEUTROPHIL LYMPHOCYTE COUNT RATIO IN PREDICTING 28 DAYS MORTALITY WILL BE COMPARED AND CORRELATION BETWEEN THEM ASSESSED. |