| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A419||Sepsis, unspecified organism, |
|
|
Intervention / Comparator Agent
|
|
|
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. |