FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2018/10/016241 [Registered on: 31/10/2018] Trial Registered Prospectively
Last Modified On: 30/10/2018
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   We propose to compare two different types of blood tests at admission of a patient to intensive care unit and estimate how accurate is each one of this to predict death in intensive care unit. 
Scientific Title of Study   Comparison of admission blood lactate and unmeasured anions measured by Stewart-Fencl approach as a predictors for ICU mortality 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kiran Kumar Gudivada 
Designation  Assistant Professor 
Affiliation  St. John’s Medical College  
Address  Department of Critical Care Medicine Silver Jubliee block St. John’s Medical College Bangalore

Bangalore
KARNATAKA
560034
India 
Phone  9490887406  
Fax    
Email  gkiran17medico@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Kiran Kumar Gudivada 
Designation  Assistant Professor 
Affiliation  St. John’s Medical College  
Address  Department of Critical Care Medicine Silver Jubliee block St. John’s Medical College Bangalore

Bangalore
KARNATAKA
560034
India 
Phone  9490887406  
Fax    
Email  gkiran17medico@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Kiran Kumar Gudivada 
Designation  Assistant Professor 
Affiliation  St. John’s Medical College  
Address  Department of Critical Care Medicine Silver Jubliee block St. John’s Medical College Bangalore

Bangalore
KARNATAKA
560034
India 
Phone  9490887406  
Fax    
Email  gkiran17medico@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  StJohns Medical College and Hospital 
Address  Department of Critical Care Medicine St.Johns Medical College Bangalore, Karnataka 560034 
Type of Sponsor  Research institution and hospital 
 
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 
Kiran Kumar Gudivada  Medical ICU  Department of Critical Care Medicine Silver Jubilee Block St.Johns Medical college Bangalore
Bangalore
KARNATAKA 
9490887406

gkiran17medico@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
St.Johns Institutional Ethics Committee  No Objection Certificate 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R652||Severe sepsis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  Adult Patients admitting from emergency department directly to the ICU 
 
ExclusionCriteria 
Details  1. Patient who are already admitted for 24 hours and treated as in patient.
2. Patients who do not have blood gas analysis report within one hour of emergency medicine admission 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Primary:
Compare the ICU mortality prediction ability of unmeasured anions measured at admission by Stewart-Fencl approach and blood lactate in patients admitting from emergency department. 
Primary end point (ie., mortality) will be estimated at 48 hours after ICU admission. 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary
1. To calculate the number of patients having a different acid-base interpretation using the Stewart-Fencl approach.
2. To assess whether adding UA measured by Stewart-Fencl approach to the admission mortality prediction scores can improve their mortality prediction. 
Secondary end points will be measured at 48 hours of ICU admission. 
 
Target Sample Size   Total Sample Size="1000"
Sample Size from India="1000" 
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)   15/11/2018 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None Yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Acid-base disequilibrium is common among critically ill patients and quantifying these abnormalities may be of prognostic significance. Various approaches such as the Boston, Copenhagen and Stewart’s physicochemical approach have been proposed to interpret these abnormalities. Among these approaches, the empirical Boston method is widely used, though it has inherent limitations in complex clinical settings like hyperchloraemic acidosis.

In 1981, Stewart proposed what was described as a non-empirical method based on physicochemical fundamentals of acid-base physiology. Although Stewart’s approach is based on sound principles, solving the complex polynomial equations involved in it at the bedside was difficult and resulted in poor adoption of the method by clinicians. Hence, in early 1990’s, Fencl proposed simplified equations, which were easily applicable at the bedside. Unfortunately, even this has not lead to its increased applicability. Fundamentally, the physicochemical and empirical approaches aim at measuring unmeasured anions (UA) in an attempt to grade the severity of disease process. Blood lactate is another easily measured and is one of the components of the UA.

The Fencl approach at the bedside has not been well described in ICU populations. We propose to compare the ICU mortality predictive ability of admission blood lactate and the unmeasured anions measured by Stewart-Fencl method.

METHODOLOGY

Step 1: This study includes all patients admitted to St. John’s Medical College Medical ICU from the Emergency medicine department for a period of one year prospectively. Demographic data, admission severity and mortality prediction scores (APACHE-II, SOFA, MPM II, MODS) of all the patients will be recorded. Routine admission blood gas values including standard base excess (SBE), electrolytes, albumin and lactate levels will be captured. Unmeasured anions will be calculated using simplified Stewart-Fencl approach.16

Step 2: Patients will be followed till the discharge from ICU. Patients will be categorized into dead or alive. It will then be tested whether the unmeasured anions measured by Stewart-Fencl approach is superior to arterial blood lactate levels at admission to predict the mortality at 48 hours and ICU mortality. It is also tested whether Stewart-Fencl approach can unmasks the hidden acid-base abnormalities, which are not detected, by SBE and AG.

Step 3: Summary statistics will be reported using mean and standard deviation for continuous variables and median and IQR for non-normally distributed variables. Bivariate analyses using Chi- square test will be used to compare the predictors. Logistic regression analysis will be used with ICU mortality as the dependent variable and UA, lactate and other co-variates as the independent variables. Based on the discriminative ability of the predictive models the predictive power of the co-variated would be compared using ROC curves. All the analyses will be carried out using STATA (version:13.0).

 
Close