| CTRI Number |
CTRI/2024/07/070338 [Registered on: 09/07/2024] Trial Registered Prospectively |
| Last Modified On: |
08/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Lactate level in blood as a predictor in patients with serious sepsis. |
|
Scientific Title of Study
|
Significance of arterial lactate levels as a mortality indicator in sepsis patients. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sowmya M J |
| Designation |
Professor |
| Affiliation |
Rajarajeswari medical college and hospital |
| Address |
Department of Anaesthesiology,
Rajarajeswari medical college and Hospital,Bangalore
Rajarajeswari medical college and Hospital,Bangalore
Bangalore
KARNATAKA
560074
India |
| Phone |
9880574092 |
| Fax |
|
| Email |
drsowmyamj80@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nadia Rose |
| Designation |
Associate Professor |
| Affiliation |
Raja Rajeswari Medical College and Hospital |
| Address |
Department of Anaesthesiology,
Rajarajeswari medical college and Hospital,Bangalore
Bangalore
KARNATAKA
560074
India |
| Phone |
09513454567 |
| Fax |
|
| Email |
dr.nadia.rose@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nadia Rose |
| Designation |
Associate Professor |
| Affiliation |
Raja Rajeswari Medical College and Hospital |
| Address |
Department of Anaesthesiology,
Rajarajeswari medical college and Hospital,Bangalore
Bangalore
KARNATAKA
560074
India |
| Phone |
09513454567 |
| Fax |
|
| Email |
dr.nadia.rose@gmail.com |
|
|
Source of Monetary or Material Support
|
| raja rajeswari medical college and hospital,mysore road,Bangalore,Karnataka-560074,India |
|
|
Primary Sponsor
|
| Name |
Raja Rajeswari Medical College and Hospital |
| Address |
Department of Anaesthesiology,
Rajarajeswari medical college and Hospital,Bangalore-560074
India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| DrSowmya |
Rajarajeswari Medical college and hospital |
Department of Anaesthesiology,
Rajarajeswari medical college and Hospital,Bangalore
Bangalore
KARNATAKA |
9880574092
dr.nadia.rose@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Rajarajeswari medical college and hospital instituitional ethics committe |
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 |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with sepsis admitted to ICU |
|
| ExclusionCriteria |
| Details |
Patients/legally responsible relatives of patient refusal to participate in study, unable to do sixth hour follow up for lactate levels, initial lactate less than 2 mmol per litre,history of major surgery,polytrauma,HIV,malignancy,pregnancy,patients taking biguanides or salicylates |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the association of initial arterial lactate level and thirtyth day outcome in patients with sepsis |
day 1 and day30 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
to determine the association of arterial lactate clearance and thirtyth day outcome in septic patients
|
day1 and day30 |
| to compare the association between initial arterial lactate level and lactate clearance with thirtyth day mortality in patients with sepsis |
day1 and day30 |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
29/07/2024 |
| 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="0"
Months="6"
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
|
Sepsis
is the leading cause of morbidity and mortality and the second commonest cause
of death worldwide. Raised blood lactate levels in severe sepsis
and septic shock usually indicate impaired oxidative phosphorylation secondary
to reduced oxygen availability to the cells (hypoxic hypoxia) and/or tissue
hypoperfusion (stagnant hypoxia). Because blood lactate levels can be measured
easily and quickly, these have been used as a predictor of tissue hypoperfusion
in critically ill patients admitted to the intensive care unit (ICU). Systematic studies on arterial lactate and lactate clearance are lacking in the
Indian subpopulation with sepsis. In the present study, we aim to determine
association of arterial lactate and lactate clearance and 30th day mortality in
patients with sepsis |