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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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