| CTRI Number |
CTRI/2024/02/062479 [Registered on: 09/02/2024] Trial Registered Prospectively |
| Last Modified On: |
27/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to predict the course of disease using alternative marker in patients with severe infection |
|
Scientific Title of Study
|
Prognostic value of prothrombin time - international normalised ratio to albumin ratio in patients with sepsis |
| 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 Sanchit Mittal |
| Designation |
Junior Resident, Department of General Medicine |
| Affiliation |
Kasturba Medical College, MAHE, Manipal |
| Address |
Department of General Medicine, second floor, OPD Block, Kasturba Medical College, MAHE, Manipal, Karnataka- 576104
Udupi KARNATAKA 576104 India |
| Phone |
8826729551 |
| Fax |
|
| Email |
sanchitmittal29@yahoo.in |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sanchit Mittal |
| Designation |
Junior Resident, Department of General Medicine |
| Affiliation |
Kasturba Medical College, MAHE, Manipal |
| Address |
Department of General Medicine, second floor, OPD Block, Kasturba Medical College, MAHE, Manipal, Karnataka- 576104
Udupi KARNATAKA 576104 India |
| Phone |
8826729551 |
| Fax |
|
| Email |
sanchitmittal29@yahoo.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Poonam Kamath |
| Designation |
Senior Resident, Department of General Medicine |
| Affiliation |
Kasturba Medical College, MAHE, Manipal |
| Address |
Department of General Medicine, second floor, OPD Block, Kasturba Medical College, MAHE, Manipal, Karnataka- 576104
Udupi KARNATAKA 576104 India |
| Phone |
8277558830 |
| Fax |
|
| Email |
kamath.poonam@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Hospital, Manipal |
|
|
Primary Sponsor
|
| Name |
Dr Sanchit Mittal |
| Address |
Department of General Medicine, second floor, OPD Block, Kasturba Medical College, MAHE, Manipal, Karnataka- 576104 |
| 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 Sanchit Mittal |
Kasturba Hospital, Manipal |
Department of General Medicine, second floor, OPD Block, Kasturba Medical College, MAHE, Manipal, Karnataka- 576104 Udupi KARNATAKA |
8826729551
sanchitmittal29@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2 |
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 since it is an observational study |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients admitted with the diagnosis of Sepsis in Kasturba Hospital, Manipal under the Department of General medicine 2) quick sequential organ failure assessment score (qSOFA) of 2 or more in patients with presumed infection will be used to define sepsis |
|
| ExclusionCriteria |
| Details |
1) Lack of PT-INR or albumin data within 24 hours of diagnosis of sepsis.
2) Pregnant patients
3) Patients with Malignancy
4) Patients on Anti coagulation therapy
5) Liver transplantation
6) Renal diseases like Nephrotic and Nephritic syndrome
7) Obstructive jaundice
8) Patients who have received Albumin or undergone plasmapheresis
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To calculate the PT-INR to Albumin ratio in patients with sepsis and it’s prognostic efficiency in predicting patient outcome. |
At the time of discharge or death |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
|  To correlate the PT-INR to Albumin ratio with requirement of Mechanical Ventilation, Hemodialysis and Inotropes. |
During the hospital stay of patient |
|  To compare the PT-INR to Albumin score with APACHE II score in predicting mortality in patients with sepsis |
At the time of discharge or death |
|
|
Target Sample Size
|
Total Sample Size="140" Sample Size from India="140"
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)
|
15/02/2024 |
| 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="1" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
NEED FOR THE
STUDY
Liver is a
key integrator of microbial response and is a target organ during sepsis. An
early and accurate assessment of liver function is critical in patients with
sepsis and monitoring of hepatic dysfunction can serve as an independent
predictor of mortality in sepsis. Several studies have shown that prothrombin
time–international normalized ratio to albumin ratio showed good discrimination
ability for predicting mortality and served as a convenient and practical tool
for predicting prognosis of critically ill patients. Higher prothrombin
time–international normalized ratio to albumin ratio are associated with
greater risk for liver cirrhosis, post-operative liver failure and worse
patient prognosis.
DESCRIPTION
Patients
will be selected based on the above inclusion exclusion criteria and recruited
into the study after taking written informed consent. Prothrombin
time–international normalized ratio to albumin ratio (PTAR Score) will be
calculated and the patients will be divided into High, Intermediate and Low
PTAR scores.
Data about
the patient’s requirement for Mechanical Ventilation, Inotropic support and
Hemodialysis will be collected.
Acute
Physiology and Chronic Health Evaluation (APACHE II) Score will be calculated.
The
collected data will be tabulated and analysed. The data will be recorded in MS
Excel spreadsheet and statistics will be elaborated in the form of
means/standard deviations and medians/IQRs for continuous variables, and
frequencies and percentages for categorical variables.
Linear
correlation between two continuous variables will be explored using Pearson’s
correlation and Spearman’s correlation. |