| CTRI Number |
CTRI/2022/10/046875 [Registered on: 28/10/2022] Trial Registered Prospectively |
| Last Modified On: |
27/10/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of balanced crystalloids versus normal saline for fluid resuscitation in sepsis patients . |
|
Scientific Title of Study
|
Comparative study of Normal saline versus balanced crystalloids as fluid resuscitation in sepsis patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr PRAVEENA R |
| Designation |
Post graduate medical student |
| Affiliation |
Bangalore Medical college and Research centre |
| Address |
Department of Anaesthesiology, Bangalore Medical college and Research institute , K R Market , Bangalore 560002
Bangalore
KARNATAKA
560002
India |
| Phone |
9110248311 |
| Fax |
|
| Email |
Praveenar03@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijaykumar H N |
| Designation |
Associate professor |
| Affiliation |
BMCRI |
| Address |
Department of Anaesthesiology, Bangalore Medical college and Research institute , K R Market , Bangalore 560002
Bangalore
KARNATAKA
560002
India |
| Phone |
9886504680 |
| Fax |
|
| Email |
Vijay.bmc.ccm@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vijaykumar H N |
| Designation |
Associate professor |
| Affiliation |
BMCRI |
| Address |
Department of Anaesthesiology, Bangalore Medical college and Research institute , K R Market , Bangalore 560002
Bangalore
KARNATAKA
560002
India |
| Phone |
9886504680 |
| Fax |
|
| Email |
Vijay.bmc.ccm@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, Bangalore Medical college and Research institute , K R Market , Bangalore 560002 |
|
|
Primary Sponsor
|
| Name |
BMCRI |
| Address |
Department of Anaesthesiology, Bangalore Medical college and Research institute , K R Market , Bangalore 560002 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Vijaykumar H N |
Department of Anaesthesiology, Bangalore Medical college and Research institute , K R Market , Bangalore 560002 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Praveena R |
Victoria hospital |
Department of Anaesthesiology , Bangalore medical college and research institute , KR market , 560002 , Bangalore Karnataka
Bangalore
KARNATAKA |
911024311
Praveenar03@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BMCRI Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A418||Other specified sepsis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Balanced crystalloids |
Balanced crystalloids are better choice of fluid in sepsis patients . Given Intravenous till the MAP is 30 mmHg |
| Comparator Agent |
Normal saline |
Normal saline though it’s a best fluid choice for resuscitation, chances of hyperchloremic acidosis are more in normal saline as fluid of choice in sepsis patients |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Sepsis patient admitted to ICU |
|
| ExclusionCriteria |
| Details |
Patients with h/o pre existing cardiac dysfunction
Patients with intracranial bleed or traumatic brain injury , hemorrhagic shock .
Patients with pre existing hyperkalemia
Patients with h/o chronic dialysis or renal transplant |
|
|
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 |
In hospital mortality and ICU mortality
ICU free days
Number of mechanical ventilator free days |
In hospital mortality and ICU mortality at 14 th and 28th day
ICU free days
Number of mechanical ventilator free days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Receipt of new renal replacement therapy |
30 days |
|
|
Target Sample Size
|
Total Sample Size="365"
Sample Size from India="365"
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)
|
28/10/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
28/10/2022 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is intended to compare normal saline versus balanced crystalloids in sepsis patient and to determine possible outcomes and fluid of choice in sepsis patient . |