| CTRI Number |
CTRI/2025/10/096370 [Registered on: 22/10/2025] Trial Registered Prospectively |
| Last Modified On: |
22/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross sectional |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
How Blood Lactate Levels Reflect Oxygen, hemoglobin and Acidity Changes in Critically Ill Patients |
|
Scientific Title of Study
|
CORRELATION OF SERUM LACTATES WITH PH, HB AND PAO2 IN PATIENT ADMITTED IN CRITICALCARE UNIT. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Akshaya N. Shetti |
| Designation |
Professor and HOD , Department of Anesthesiology |
| Affiliation |
Pravara Institute Of Medical Sciences, Loni |
| Address |
Rural Medical College, Pravara Institute of Medical Sciences, Loni
Ahmadnagar
MAHARASHTRA
413736
India |
| Phone |
7507807673 |
| Fax |
|
| Email |
aksnsdr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Akshaya N. Shetti |
| Designation |
Professor and HOD , Department of Anesthesiology |
| Affiliation |
Pravara Institute Of Medical Sciences, Loni |
| Address |
Rural Medical College, Pravara Institute Of Medical Sciences, Loni
Ahmadnagar
MAHARASHTRA
413736
India |
| Phone |
7507807673 |
| Fax |
|
| Email |
aksnsdr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Akshaya N. Shetti |
| Designation |
Professor and HOD , Department of Anesthesiology |
| Affiliation |
Pravara Institute Of Medical Sciences, Loni |
| Address |
Rural Medical, Pravara Institute Of Medical Sciences, Loni
Ahmadnagar
MAHARASHTRA
413736
India |
| Phone |
7507807673 |
| Fax |
|
| Email |
aksnsdr@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Akshaya N Shetti |
| Address |
Pravara Institute Of Medical Sciences, Loni, Ahmednagar, MAHARASHTRA,413736 |
| Type of Sponsor |
Other [Self] |
|
|
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 Akshaya N Shetti |
Pravara Institute Of Medical Sciences |
Department of Anaesthesiology and Critical Care, Pravara Institute Of Medical Sciences, Loni
Ahmadnagar
MAHARASHTRA |
7507807673
aksnsdr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee , Pravara Institute Of Medical Sciences- Deemed University (IEC UG/PG RMC ) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R799||Abnormal finding of blood chemistry, unspecified, |
|
|
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 |
Patients admitted to ICU requiring ABG analysis. Age more than 18 years.
Informed consent from patient/attendant. |
|
| ExclusionCriteria |
| Details |
Chronic liver failure (affects lactate clearance).
Known inborn errors of metabolism.
Patients on metformin toxicity / cyanide poisoning. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Negative correlation between lactate & pH, HCO3.
Negative correlation between lactate & Hb.
Negative correlation between lactate & PaO2
Positive correlation between lactate & PaCO2 (in uncompensated states).
Higher lactate associated with increased ICU mortality. |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
07/11/2025 |
| 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="1"
Days="7" |
|
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
|
Critically ill patients often present with metabolic and respiratoryderangements. Serum lactate is a well-established marker of tissue hypoxiaand impaired cellular metabolism. Elevated lactate levels are associatedwith poor prognosis, multi-organ dysfunction, and increased mortality in ICU patients AIM:To study the correlation between serum lactate levels and pH, hemoglobin, partial pressure of oxygen , partial pressure of carbon dioxide in patients admitted to the critical care unit. OBJECTIVES: 1. To measure serum lactate levels in critically ill patients on admissionand during ICU stay. 2. To determine correlation between lactate and arterial pH. 3. To determine correlation between lactate and hemoglobinconcentration. 4. To determinerelation between c SIGNIFICANCE OF THE STUDY: Helps in understanding the pathophysiological relationships oflactate with ABG and Hb. Provides prognostic insight in critically ill patients. May improve early risk stratification and treatment decisions in ICU. |