CTRI

FULL DETAILS (Read-only) -> Click Here to Create PDF for Current Dataset of Trial

CTRI Number

CTRI/2021/09/036902 [Registered on: 28/09/2021] Trial Registered Prospectively

Last Modified On:

24/09/2021

Post Graduate Thesis

Yes

Type of Trial

Observational

Type of Study

Cross Sectional Study

Study Design

Single Arm Study

Public Title of Study

A clinical trial to study the efficacy of two tests, SOFA score plus procalcitonin and SOFA score alone, in patients with sepsis

Scientific Title of Study

Comparison of SOFA score and serum procalcitonin combination with SOFA score alone in predicting short-term mortality in 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	Dr Amit Raja Panigrahi
Designation	Academic Senior Resident
Affiliation	ABVIMS and Dr RML hospital
Address	Dept of Critical care medicine Trauma building ABVIMS and Dr RML hospital New Delhi DELHI 110001 India
Phone	8917243009
Fax
Email	drarpclinic@gmail.com

Details of Contact Person
Scientific Query

Name	Prof Ranvinder Kaur
Designation	Director professor and HOD
Affiliation	ABVIMS and Dr RML hospital
Address	Dept of Critical care medicine Trauma building ABVIMS and Dr RML hospital New Delhi DELHI 110001 India
Phone	9717932744
Fax
Email	rsindhoo@yahoo.co.in

Details of Contact Person
Public Query

Name	Prof Ranvinder Kaur
Designation	Director professor and HOD
Affiliation	ABVIMS and Dr RML hospital
Address	Dept of Critical care medicine Trauma building ABVIMS and Dr RML hospital New Delhi DELHI 110001 India
Phone	9717932744
Fax
Email	rsindhoo@yahoo.co.in

Source of Monetary or Material Support

ABVIMS and Dr RML hospital New Delhi

Primary Sponsor

Name	ABVIMS and Dr RML hospital
Address	Baba Kharak Singh marg New Delhi 110001
Type of Sponsor	Government 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 Amit Panigrahi	ABVIMS and Dr RML Hospital Baba Kharak Singh Marg	Multidisciplinary ICU Dept of critical care medicine Trauma building ground floor and second floor New Delhi DELHI	8917243009 drarpclinic@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethics Committee ABVIMS Dr RML Hospital New Delhi	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
Comparator Agent	Nil	Nil

Inclusion Criteria

Age From	18.00 Year(s)
Age To	99.00 Year(s)
Gender	Both
Details	Patients aged more than equal to 18 years Patients with diagnosis of Sepsis and or Septic shock Patients with ICU stay of at least 24 hours

ExclusionCriteria

Details

Refusal of Consent
Pregnant and lactating females
Patients who later turn out to be non sepsis
Acute non infectious inflammatory conditions like burns, acute pancreatitis, massive trauma
Patients with chronic kidney disease Stage IV and V
Patients on immunosuppressive medications
Patients with terminal cancer
Patients with thyroid cancer any stage

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
Short term mortality or 28 day mortality in patients with sepsis	From admission into ICU till 28th day thereafter

Secondary Outcome

Outcome	TimePoints
Microbial culture result Duration of mechanical ventilation and or non-invasive ventilation Usage of inotropes or vasopressors Need for renal replacement therapy Length of ICU stay	From admission into ICU till 28th day thereafter

Target Sample Size

Total Sample Size="160"
Sample Size from India="160"
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)

01/10/2021

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="0"
Days="0"

Recruitment Status of Trial (Global)

Not Applicable

Recruitment Status of Trial (India)

Not Yet Recruiting

Publication Details

Intend to publish article in a reputed scientific journal after successful completion of the trial

Individual Participant Data (IPD) Sharing Statement

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

Response - YES

What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identiﬁcation (text, tables, ﬁgures, and appendices).

What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Who will be able to view these files?
Response (Others) - Researchers and doctors in the field of critical care medicine

For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.

By what mechanism will data be made available?
Response (Others) - Data will be available at ABVIMS and Dr RML hospital library as well as with the journal that publishes the article

For how long will this data be available start date provided 01-11-2022 and end date provided 31-10-2032?
Response - Immediately following publication. No end date.

Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil

Brief Summary

Sepsis continues to be a major public health problem globally. The worldwide burden of sepsis is difficult to ascertain although a recently published article indicates that there were an estimated 48Â·9 million incident cases of sepsis and 11Â·0 million sepsis-related deaths in 2017 representing 19Â·7% of deaths that year. These estimates are more than double of previous global figures, which is probably due to addition of data from low-income and middle-income countries, locations where the incidence of sepsis and associated mortality are significantly higher and for which data were previously unknown. Prevalence of sepsis-related mortality varies considerably according to location. Significant regional disparities in sepsis incidence and mortality exist; approximately 85.0% of sepsis cases and sepsis related deaths worldwide occurred in low- and middle-income countries. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3), defines sepsis as a life-threatening organ dysfunction caused by dysregulated host response to infection. Early identification and diagnosis are essential, as prompt and appropriate treatment can improve survival outcomes. Despite advances in antibiotic therapy and modern life support, the fatality rate of patients with sepsis has remained as high as 30%-50% worldwide. Early identification of patients at high risk of dying from sepsis may help initiate rapid and appropriate therapeutic interventions and may have a great impact on sepsis-related morbidity and mortality. However, an accurate assessment of patients at risk for poor clinical outcomes is challenging for clinicians. Clinical severity scores, such as the Sequential Organ Failure Assessment (SOFA) score, have been validated for risk stratification in critical care settings. However, in recent years, a number of blood biomarkers have been identified that may provide additional information to estimate disease progression in sepsis. Procalcitonin (PCT), the pre-hormone of calcitonin, has been widely investigated in infectious diseases. Apart from its diagnostic value, an elevated PCT concentrations was reported to be strongly associated with all-cause mortality in septic patients. The purpose of this study is to compare SOFA score and serum procalcitonin combination with SOFA score alone in predicting shortterm mortality i.e 28-day mortality in patients with sepsis.