| CTRI Number |
CTRI/2018/04/013384 [Registered on: 19/04/2018] Trial Registered Prospectively |
| Last Modified On: |
12/04/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Steroids Thiamine and Vitamin C in Septic Shock |
|
Scientific Title of Study
|
Hydrocortisone, Vitamin C and Thiamine for the Treatment of Severe Sepsis and Septic Shock |
| Trial Acronym |
STACSS |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sunil Patil |
| Designation |
Fellow |
| Affiliation |
Jaslok Hospital |
| Address |
19th Floor
Dept of Critical Care Medicine
Jaslok Hospital
Pedder Road
Mumbai
Mumbai
MAHARASHTRA
400026
India |
| Phone |
9082197568 |
| Fax |
|
| Email |
drsunilpatil49@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shruti Tandan |
| Designation |
Consultant |
| Affiliation |
Jaslok Hospital |
| Address |
19th Floor
Dept of Critical Care Medicine
Pedder Road
Mumbai
Mumbai
MAHARASHTRA
400026
India |
| Phone |
9323868081 |
| Fax |
|
| Email |
shrutitandan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shruti Tandan |
| Designation |
Consultant |
| Affiliation |
Jaslok Hospital |
| Address |
19th Floor
Dept of Critical Care Medicine
Pedder Road
Mumbai
Mumbai
MAHARASHTRA
400026
India |
| Phone |
9323868081 |
| Fax |
|
| Email |
shrutitandan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jaslok Hospital & Research Centre
Pedder Road
Mumbai-400026
Maharashtra |
|
|
Primary Sponsor
|
| Name |
Jaslok Hospital |
| Address |
Pedder Road
Mumbai |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Sunil Patil |
Jaslok hospital and research centre |
19th floor Department of critical care
pedder road mumbai 400026
Mumbai
MAHARASHTRA |
9082197568
drsunilpatil49@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Jaslok Hospital Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Septic Shock, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intravenous hydrocortisone
Intravenous ascorbic acid
Intravenous Thiamine
|
Hydrocortisone 50 mg iv 6 hrly for 5 days
Ascorbic acid 1.5 gm iv 6 hrly for 4 days
Thiamine 200 mg iv 12 hrly for 4 days |
| Comparator Agent |
Placebo |
Intravenous saline in similar quantity and duration to the test drugs |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients admitted to the Critical Care Unit who demonstrate 2 or more of the following symptoms :
Temperature <36 or >38
Pulse >90 bpm
White Cell Count of <4000 or >11000
Respiratory Rate >20
New Confusion
Systolic BP < 90 mm of Hg or diastolic<60 or MAP<65 for >1h despite fluid resuscitation
Culture positive or strong suspicion of infection with Procalcitonin level >2ng/ml
|
|
| ExclusionCriteria |
| Details |
1) Pregnant patients
2) Patients who die within 24 hrs of admission
3) Terminal illness
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reversal of shock: Off Vasopressors24h
28-Day Mortality Rate
|
Reversal of shock: Off Vasopressors24h
28-Day Mortality Rate
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Procalcitonin clearance
length of icu stay
|
clearance at 72 hours |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
25/04/2018 |
| 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
|
Marik PE et al. Hydrocortisone, Vitamin C and Thiamine for the Treatment of Severe Sepsis and Septic Shock: A retrospective Before-After Study. Chest 2016.S0012-3692(16)62564 – 3
Donnino MW, Carney E, Cocchi MN, et al. Thiamine deficiency in critically ill patients with sepsis. J Crit Care 2010;25:576-81
Sprung CL, Annane D, Keh D, et al. Hydrocortisone therapy for patients with
septic shock. N Engl J Med. 2008;358(2):111-124 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Parenterally administered ascorbic acid modulates sepsis-induced inflammation & coagulation. Intravenous ascorbic acid infusion was well tolerated in a study & may positively impact multiple organ failure & biomarkers of inflammation & endothelial injury. Thiamine has a role as a metabolic resuscitator in septic shock. A relative adrenal insufficiency is postulated in patients with septic shock. There is thus encouraging emerging data on the use of thiamine, steroids & vitamin C in septic shock. We plan a randomised placebo controlled clinical trial to study the effect of these drugs in septic shock on 28 mortality, inotrope withdrawal and ICU stay |