| CTRI Number |
CTRI/2020/07/026429 [Registered on: 08/07/2020] Trial Registered Prospectively |
| Last Modified On: |
07/07/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Biological |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Therapeutic measures in Sepsis patients. |
|
Scientific Title of Study
|
Effect of supplementation of Albumin in patients of Sepsis with hypoalbuminemia. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Monika G |
| Designation |
Post graduate doctor |
| Affiliation |
Maulana Azad Medical College ,New Delhi |
| Address |
Department of Medicine
Maualana Azad Medical College,
Bahadur Shah Zafar Marg,
New Delhi
Central
DELHI
110002
India |
| Phone |
9811971751 |
| Fax |
|
| Email |
monicaegk999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mradul Kumar Daga |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College, New Delhi |
| Address |
Department of Medicine
Maulana Azad Medical College,
Bahadur Shah Zafar Marg,
New Delhi
Central
DELHI
110002
India |
| Phone |
9968604273 |
| Fax |
|
| Email |
drmraduldaga@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Monika G |
| Designation |
Post graduate Doctor |
| Affiliation |
Maulana Azad Medical College ,New Delhi |
| Address |
Department of Medicine
Maualana Azad Medical College,
Bahadur Shah Zafar Marg,
New Delhi
Central
DELHI
110002
India |
| Phone |
9811971751 |
| Fax |
|
| Email |
monicaegk999@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College And Associated Lok Nayak Hospital,Bahadur Shah Zafar Marg,New Delhi-110002 |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
Bahadur Shah Zafar Marg,New Delhi,India-110002 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Mradul Kumar Daga |
Department of Medicine,Maulana Azad Medical College and Associated Lok Nayak Hospital, Bahadur Shah Zafar Marg, New Delhi,India-110002 |
| Dr Sandeep Garg |
Department of Medicine,Maulana Azad Medical College and Associated Lok Nayak Hospital, Bahadur Shah Zafar Marg, New Delhi,India-110002 |
| Dr Smita Kaushik |
Department of Biochemistry,Maulana Azad Medical College and Associated Lok Nayak Hospital, Bahadur Shah Zafar Marg, New Delhi,India-110002 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Monika G |
Lok Nayak Hospital |
Maulana Azad Medical College and Associated Lok Nayak Hospital, Bahadur Shah Zafar Marg, New Delhi,India-110002
Central
DELHI |
9811971751
monicaegk999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional Ethics Committee,Maulana Azad Medical College and Associated Lok Nayak Hospital,GIPMER and GNEC,New Delhi-110002 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R652||Severe sepsis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Standard treatment of sepsis |
Only standard treatment of sepsis given according to latest guidelines |
| Intervention |
Supplementation of Albumin |
Supplementation of albumin in patients of sepsis with hypoalbuminemia
300ml of 20% Albumin solution on first day,then 200ml/day during hospital stay provided their serum albumin concentration is 3.1g/dl |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients of sepsis as per standard criteria laid down in sepsis guidelines 2016(sepsis 3) with hypoalbuminemia |
|
| ExclusionCriteria |
| Details |
Patients with chronic liver disease and chronic kidney disease
Expected length of hospital stay is less then 3 days
Evidence of fluid overload
Patients of burns and trauma
Immunocompromised status
Patients of anaphylaxis and adrenal insufficiency
Malnourishment and malabsorption |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Disease outcome-Recovery/mortality |
Less than or equal to one year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Length of Hospital stay
|
Less than or equal to one year |
Duration of antibiotic therapy
|
Less than or equal to one year |
Duration of inotropic support and ventilation
|
Less than or equal to one year |
| Transfer to ICU and Length of ICU stay |
Less than or equal to one year |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
10/07/2020 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Effective, safe pharmacological agents are need of the hour in the management of sepsis. Aims and objectives: 1. To study the effect of supplementation of albumin in sepsis patients with hypoalbuminemia 2. To study the prognostic value of ratio of CRP/albumin in outcome of sepsis |