| CTRI Number |
CTRI/2009/091/000650 [Registered on: 01/10/2009] |
| Last Modified On: |
07/01/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug
Biological |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
Public Title of Study
Modification(s)
|
Ulinastatin in Severe Sepsis |
|
Scientific Title of Study
|
A prospective, multicentric, double-blind, randomised, phase III clinical study to compare the efficacy and safety of intravenous Ulinastatin versus placebo alongwith standard supportive care in subjects of severe sepsis |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| doi: 10.1007/s00134-014-3278-8 |
Other |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Dilip Karnad |
| Designation |
Consultant Intensivist |
| Affiliation |
Jupiter Hospital |
| Address |
Intensive Care Unit
Thane
MAHARASHTRA
400605
India |
| Phone |
9892114002 |
| Fax |
|
| Email |
drkarnad@rediffmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Dilip Karnad |
| Designation |
Consultant Intensivist |
| Affiliation |
Jupitar Hospital |
| Address |
Intensive Care Unit
Thane
MAHARASHTRA
400605
India |
| Phone |
9892114002 |
| Fax |
|
| Email |
drkarnad@rediffmail.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Ms Naju Turakhia |
| Designation |
General Manager - Clinical Research |
| Affiliation |
Bharat Serums and Vaccines limited |
| Address |
Bharat Serums & Vaccines Ltd, 17th flr, Hoechst House, Nariman Point,Mumbai - 400021
Mumbai
MAHARASHTRA
400021
India |
| Phone |
02261383456 |
| Fax |
02261383400 |
| Email |
naju.turakhia@bharatserums.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Bharat serums and Vaccines ltd.
Limited
17th floor, Hoechst House, Nariman Point,Mumbai - 400021 |
|
Primary Sponsor
Modification(s)
|
| Name |
Bharat Serums and Vaccines Limited |
| Address |
17th floor, Hoechst House, Nariman Point,Mumbai - 400021 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 7 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr P K Verma |
V. M. Medical College & Safdarjung Hospital |
Department of Anaesthesia & ICU, V.M. Medical College and Safdarjung Hospital, AIIMS Crossing, New Delhi -110029
New Delhi
DELHI |
01126165032
prateekverma88@hotmail.com |
| Dr Rakesh Bhadade |
B Y L Nair Hospital & T N Medical College |
Department of Medicine, B.Y.L. Nair Hospital & T.N. medical College, Bombay Central, Mumbai - 400008
Mumbai
MAHARASHTRA |
02223081490
rakeshbhadade@gmail.com |
| Dr Siddharth Shah |
Bhatia Hospital |
Bhatia Hospital, Tardeo Road, Mumbai Central,
Mumbai – 400 007
Mumbai
MAHARASHTRA |
9819888500
drsns@in.com |
| Dr Shivakumar Iyer |
JCDC Pvt Ltd. Jahangir Hospital |
Jehangir Clinical Development Centre Pvt. Ltd, Jehangir Hospital, 32 Sasson Road, Pune – 411 001
Pune
MAHARASHTRA |
02028059318
02026059319
suchietashiva@gmail.com |
| Dr N D Moulick |
Lokmanya Tilak Muncipal General Hospital & Lokmanya Tilak Muncipal Medical College |
Depertment of Medicine, 1st Floor, College Building, Lokmanya Tilak Municipal Medical College & Lokmanya Tilak Municipal General Hospital, Sion,Mumbai - 400022
Mumbai
MAHARASHTRA |
02224076381
02224076100
ndmoulick@rediffmail.com |
| Dr Mradul Daga |
Maulana Azad Medical College |
Room No. 129, Department of Medicine, Maulana Azad medical College and attached Lok nayak Hospital, Bahadur Shah Zafar Marg,New Delhi -110002
New Delhi
DELHI |
011-23239271
mradul.daga@gmail.com |
| Dr Neelima Chafekar |
N.D.M.V.P. Samaj Medical College |
Department of Medicine, N.D.M.V.P. Samaj Medical College, Vasantdada Nagar,Adgaon, Nashik-422003
Nashik
MAHARASHTRA |
9822408536
neelimachafekar@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 7 |
| Name of Committee |
Approval Status |
| Medical Research society ethics committee, Bhatia Hospital |
Approved |
| B Y L Nair Hospital & T N Medical College Ethics Committee |
Approved |
| Ethical Committee, V.M Medical College & Safdarjung Hospital |
Approved |
| Institutional ethics committee, N.D.M.V.P. Samaj Medical College |
Approved |
| Institutional Ethics Committee, LTMMC & LTMGH |
Approved |
| Jehangir Clinical Development Centre Ethics Committee |
Approved |
| Maulana Azad Medical College, Institutional Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R652||Severe sepsis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
b.d. x 5 days |
| Intervention |
Ulinastatin |
200000IU b.d. X 5 days |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
I. Age >18yrs <60yrs (both inclusive) & weight <135kg
II. Patient has to have a known infection or a suspected infection, as evidenced by one or more of the following:
1. White cells in a normally sterile body fluid
2. Perforated viscus
3. Radiographic evidence of pneumonia in association with the production of purulent sputum
4. A syndrome associated with a high risk of infection (e.g., ascending cholangitis)
III. Modified SIRS criteria
IV. One dysfunctional organ / system |
|
| ExclusionCriteria |
| Details |
1. Pregnancy or breast-feeding
2. Age < 18yr or weight > 135 kg
3. Platelet count < 30,000/mm3.
4. Conditions that increase the risk of bleeding
5. Moribund state in which death was perceived to be imminent (≤ 24 hours)
6. History of bone marrow, lung, liver, pancreas or small-bowel transplantation
7. Chronic renal failure requiring hemodialysis or peritoneal dialysis
8. Known or suspected portosystemic hypertension, chronic jaundice, cirrhosis or chronic ascites
9. Participation in another investigational study within 30 days before the current study
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. 28 day mortality
2. Prevention of new onset organ failure
3. Improvement of hemodynamics, i.e., time to stoppage of vasopressors
|
Day 5, discharge and Day 28 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. Percentage of subjects achieving subsidence of sepsis (microbiological and clinical).
2. Average length of hospital stay (days) till discharge in survivors.
3. Duration of assisted ventilation, if any.
4. Reduction in APACHE II scores |
Day 5, discharge and Day 28 |
|
Target Sample Size
Modification(s)
|
Total Sample Size="122"
Sample Size from India="122"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="122" |
|
Phase of Trial
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
30/09/2009 |
| Date of Study Completion (India) |
10/06/2010 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Karnad DR, Bhadade R, Verma PK,
Moulick ND, Daga MK, Chafekar ND,
Iyer S, Intravenous
administration of ulinastatin (human
urinary trypsin inhibitor) in severe
sepsis: a multicenter randomized
controlled study. Intensive Care Med
40:830–838. doi:10.1007/s00134-
014-3278-8 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study is a randomised, placebo controlled double-blind study to determine the efficacy and safety of Ulinastatin as adjuvant therapy in severe sepsis at a dose of 200000IU b.d. for 5 days.
The anti-inflammatory and anti-oxidative action of Ulinastatin would decrease the mortality and progression of disease. The efficacy endpoints are reduction in mortality, Prevention of new onset organ failure, Improvement of hemodynamics ie time to stoppage of vasopressors and shorter hospitalisation |