| CTRI Number |
CTRI/2025/07/090636 [Registered on: 10/07/2025] Trial Registered Prospectively |
| Last Modified On: |
10/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Outcomes of elevated lactate levels in patients admitted to intensive care units |
|
Scientific Title of Study
|
An Observational Study on outcomes of hyperlactatemia on admission in critically ill 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 |
Pavithradevi S |
| Designation |
Msc Critical care technology |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Reasearch |
| Address |
Sri Ramachandra Institute of Higher Education and Reasearch Department of Critical Care Medicine porur chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
9940902112 |
| Fax |
|
| Email |
spavithradevipandi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Baby sailaja |
| Designation |
Associate Professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Reasearch |
| Address |
Sri Ramachandra Institute of Higher Education and Reasearch Department of Critical Care Medicine porur chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
9600159482 |
| Fax |
|
| Email |
sailajaroop@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Renuka MK |
| Designation |
Professor and Head Of Department |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Reasearch |
| Address |
Sri Ramachandra Institute of Higher Education and Reasearch Department of Critical Care Medicine porur chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
8056126336 |
| Fax |
|
| Email |
renuka.mk@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
| SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH
Department of Critical Care Medicine Porur Chennai Tamil Nadu 600116 |
|
|
Primary Sponsor
|
| Name |
SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH |
| Address |
Department of Critical Care Medicine Sri Ramachandra Institue Of Higher Education and Research Porur chennai 600116 |
| 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 |
| DR Renuka MK |
Sri Ramachandra Institute of Higher Education and Reasearch |
Department of critical care medicine Sri Ramachandra Medical College Trunk Rd Sri Ramachandra Nagar Porur Chennai Tamilnadu 600116.
Chennai
TAMIL NADU |
08056126336
renuka.mk@sriramachandra.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SriRamachandra Institution Of Higher Education And Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: R740||Nonspecific elevation of levels oftransaminase and lactic acid dehydrogenase [LDH], |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
patient with elevated lactate levels.
clinical conditions associated with tissue hypoxia and systemic disease.
all consecutive critically ill adult age above 19 years. |
|
| ExclusionCriteria |
| Details |
neonates and paediatric patients.
incomplete records or missing data. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Development of multi organ dysfunction syndrome(MODS)
lactate clearance and its association with clinical deterioration
factors enchance lactate clearance at 24 hours and at 48 hours
abg
serum lactate
apache 2 score and sofa score |
8weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
length of ICU stay
need for organ suport(mechanical ventilation, vasopressors)
hospital mortality |
10 months |
|
|
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)
|
15/08/2025 |
| 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="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Elevated lactate levels serve as a biomarker for tissue hypoperfusion and are indicative of severe illness, especially in critically ill patients. Monitoring the underlying causes of elevated lactate is crucial to prevent further clinical deterioration. Lactate measurements are typically obtained through arterial blood gas analysis at the time of ICU admission, as well as at 24 and 48 hours post-admission. High lactate levels at admission are strongly linked to increased ICU mortality. Patients with elevated lactate are more likely to develop multi-organ dysfunction and require intensive organ support, such as vasopressors and mechanical ventilation. Importantly, admission lactate levels are an independent predictor of poor outcomes, even when adjusted for established severity scoring systems like APACHE II and SOFA. Thus, early identification of elevated lactate can provide valuable prognostic information in the management of critically ill patients |