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CTRI Number  CTRI/2023/02/049552 [Registered on: 08/02/2023] Trial Registered Prospectively
Last Modified On: 02/02/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Clinical significance of uric acid in adult patients with infection in blood 
Scientific Title of Study   Clinical significance of serum uric acid in adult patients with sepsis 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Katakam Santhoshi Nikitha 
Designation  Junior Resident 
Affiliation  Kasturba medical college, MAHE, Manipal 
Address  Department of Medicine, 2nd floor, Smt. Sharadha Pai OPD block, Kasturba Medical College, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9052233346  
Fax    
Email  nikithasanthoshi@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Chandrashekar U K  
Designation  Professor 
Affiliation  Kasturba medical college, MAHE, Manipal 
Address  Department of Medicine, 2nd floor, Smt. Sharadha Pai OPD block, Kasturba Medical College, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9845163448  
Fax    
Email  shekar.uk@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Katakam Santhoshi Nikitha 
Designation  Junior Resident 
Affiliation  Kasturba medical college, MAHE, Manipal 
Address  Department of Medicine, 2nd floor, Smt. Sharadha Pai OPD block, Kasturba Medical College, Manipal


KARNATAKA
576104
India 
Phone  9052233346  
Fax    
Email  nikithasanthoshi@gmail.com  
 
Source of Monetary or Material Support  
Kasturba Medical College, Manipal 
 
Primary Sponsor  
Name  Kasturba Medical College 
Address  Department of Medicine, 2nd floor, Smt. Shradha Pai. OPD block, Kasturba Medical College, Manipal. 
Type of Sponsor  Private medical college 
 
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 K Santhoshi Nikitha  Kasturba Medical College, MAHE, Manipal  Department of Medicine,2nd floor, Smt. sharadha Pai OPD BLOCK, Kasturba hospital, Manipal.
Udupi
KARNATAKA 
9052233346

nikithasanthoshi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College  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 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Patients aged 18 years or older admitted to medical intensive care units with clinical suspicion of sepsis based on the Sepsis-3 definition which includes sequential organ failure assessment (SOFA) score of ≥ 2 will be included in the study. 
 
ExclusionCriteria 
Details  1. Patients with chronic kidney disease, gout and those on diuretics will be excluded from the study​
2. Patients on treatment for hyperuricemia​
3. Patients with malignancies will also be excluded 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Outcome assessed interms of mean hospital stay, acute kidney injury, need for dialysis, days of mechanical ventilation, patient condition at discharge(survivors/non survivors) in relation to serum uric acid between two cohorts  At discharge/ death 
 
Secondary Outcome  
Outcome  TimePoints 
nill  nill 
 
Target Sample Size   Total Sample Size="226"
Sample Size from India="226" 
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)   15/02/2023 
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    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Our study is a prospective, cohort, observational study conducted at Kasturba Medical College, Manipal, India. Adult patients with clinical suspicion of sepsis admitted to Medical Intensive Care Units will be included in the study.

The data of the patients including demographic characteristics, comorbidity, source of infection, APACHE II Score and SOFA Score, mechanical ventilation, and length of ICU stay will be recorded in a data proforma. The presence of sepsis will be made at the time of admission among hospitalized patients based on SOFA score of ≥ 2. Vital signs, scoring system and laboratory parameters will be recorded at admission to the ICU. Laboratory data at admission including complete blood count, liver function and renal function tests, serum electrolytes, uric acid, lactate and arterial blood gas analysis will be collected and documented.

The disease severity will be evaluated with the Sequential Organ Failure Assessment (SOFA) Score and Acute Physiology and Chronic Health Evaluation (APACHE) II Score.

As this study is purely observational, patient management and antimicrobial therapy will be chosen by patient’s physician without any intervention from study investigators.

Outcome will be assessed in terms of mean hospital stay, acute kidney injury, need for dialysis, mechanical ventilation and patient condition at the time of discharge (survivors/non survivors) in relation to serum uric acid levels.

 
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