| CTRI Number |
CTRI/2024/05/067373 [Registered on: 15/05/2024] Trial Registered Prospectively |
| Last Modified On: |
13/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Comparing two ways to predict who will survive in the ICU: One uses a scoring system called APACHE IV score, while the other estimates Serum Hepcidin levels through a blood test
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Scientific Title of Study
|
Comparison of Acute Physiology and Chronic Health Evaluation IV score and serum hepcidin levels as predictor of mortality in patients admitted to intensive care unit |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Balamurugan M |
| Designation |
Post Graduate Junior Resident |
| Affiliation |
Government Medical College and Hospital, Sector 32B, Chandigarh |
| Address |
Department of Anaesthesia and intensive care, D block 5th floor, GMCH-32, Sector 32B,Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
8148361106 |
| Fax |
|
| Email |
balafrazer98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjeev Palta |
| Designation |
Professor |
| Affiliation |
Government Medical College and Hospital, Sector 32B, Chandigarh |
| Address |
Department of Anaesthesia and intensive care, D block 5th floor, GMCH-32, Sector 32B,Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121523 |
| Fax |
|
| Email |
sanjeev_palta@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anshu Palta |
| Designation |
Professor |
| Affiliation |
Government Medical College and Hospital, Sector 32B, Chandigarh |
| Address |
Department of Pathology, E block 3rd floor, GMCH-32, Sector 32B,Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121602 |
| Fax |
|
| Email |
anshupalta@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia and Intensive Care, Government Medical College and Hospital, D block, 5th floor, Sector-32, Chandigarh. India-160030 |
|
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Primary Sponsor
|
| Name |
Government Medical College and Hospital |
| Address |
Department of Anaesthesia and intensive care,D block,5th floor,Government Medical College and Hospital, Sector-32B, Chandigarh,India-160030 |
| Type of Sponsor |
Government medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Balamurugan M |
Government Medical College and Hospital |
Department of Anaesthesia and Intensive Care, Block D, Level 5, GMCH, Sector-32B,
Chandigarh,India-160030
Chandigarh
CHANDIGARH |
8148361106
balafrazer98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, GMCH, Chandigarh |
Approved |
|
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Acute Physiology and Chronic Health Evaluation IV (APACHE IV) score |
To predict the mortality of patients admitted in Intensive Care Unit by calculating APACHE IV score within 24 hours of admission |
| Intervention |
Serum hepcidin levels
|
To predict the mortality of patients admitted in Intensive Care Unit by estimating their Serum hepcidin level after 48 hours of admission |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Age more than 18 years,
Below 65 years,
Patient in ICU stay more than 48 hours |
|
| ExclusionCriteria |
| Details |
1. Refusal to consent from patient’s relative
2. ICU stay less than 2 days (shift to ward or discharge within 2 days)
3. Burns
4. Head injury
5. Patients receiving chemotherapy/ having malignancy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of Acute Physiology and Chronic Health Evaluation IV score and serum hepcidin levels as predictor of mortality in patients admitted to intensive care unit |
APACHE IV score will be calculated within 24 hours of admission in ICU.
Serum hepcidin level measured after 48 hours of admission in ICU. |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Correlation of APACHE IV score with development of sepsis and length of stay in ICU |
APACHE IV score will be calculated within 24 hours of admission in ICU. |
| Correlation of serum hepcidin levels with development of sepsis and length of stay in ICU |
Serum hepcidin level will be measured after 48 hours of admission in ICU. |
| Correlation of SOFA score to predict the development of sepsis |
SOFA score calculated after 48 hours of admission and will be done every alternate days at a given designated time |
|
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Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
28/06/2024 |
| 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="4" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
Despite advanced health setups, ICU related mortality and morbidity still remains high, this is due to lack of early diagnosis and intervention. APACHE IV score is the standard indicator for mortality. For more specific we have to find some more indicators to assess the mortality. Serum hepcidin is an acute phase reactant. In critically ill patients, hepcidin level will be increased due to its acute inflammatory action, with the help of serum hepcidin level, we can diagnose the condition specifically and treatment will be given early.
Initially APACHE IV score is calculated in patients admitted in ICU, after 48 hours of admission blood sample will be taken to evaluate serum hepcidin level. In the mean time after 48 hours of admission SOFA score is going to be calculated.it is done in every alternative days at a given designated time. SOFA score is evaluated to assess the sepsis, change in SOFA score is more than 2 from the baseline or previous one will indicate the development of sepsis. Serum hepcidin level measured under ELISA method, APACHE IV score is calculated and these measurements will be charted. We observe the outcome of the patient and correlate with measurements of serum hepcidin level and APACHE IV score. With the help of this parameter especially serum hepcidin level, we are going to assess the patient’s mortality prediction, In the way we can take appropriate steps to diagnose and manage the patient early and decrease the mortality with help of APACHE IV score and serum hepcidin level.
It was decided to enroll 80 patients in the present trial to compensate for the dropouts. Therefore, after written informed consent, 80 patients of either gender will be enrolled for the present trial according to theinclusion and exclusion criteria
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