| CTRI Number |
CTRI/2018/12/016728 [Registered on: 19/12/2018] Trial Registered Prospectively |
| Last Modified On: |
29/09/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [ intravenous fluids] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Use of two different type of fluids in head injury patients |
|
Scientific Title of Study
|
Comparison of normal saline and balanced salt solution as maintenance fluid on acid-base and electrolyte status in traumatic brain injury patients - a prospective randomized double blind study
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shephali |
| Designation |
Junior Resident |
| Affiliation |
IMS, BHU,Varanasi |
| Address |
Department of Anaesthesiology, IMS, BHU, Varanasi-221005
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9044657889 |
| Fax |
|
| Email |
addusingh22@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yashpal Singh |
| Designation |
Assistant Professor (Trauma) |
| Affiliation |
IMS, BHU,Varanasi |
| Address |
Department of Anaesthesiology, IMS, BHU, Varanasi-221005
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
09918424416 |
| Fax |
|
| Email |
dryashacin1999@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shephali |
| Designation |
Junior Resident |
| Affiliation |
IMS, BHU,Varanasi |
| Address |
Department of Anaesthesiology, IMS, BHU, Varanasi-221005
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9044657889 |
| Fax |
|
| Email |
addusingh22@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Medical Sciences, Banaras Hindu University, Varanasi-221005 |
|
|
Primary Sponsor
|
| Name |
Institute of Medical Sciences |
| Address |
Institute of Medical Sciences, Banaras Hindu University, Varanasi-221005 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Dr Shephali |
Trauma Centre |
Trauma ICU, Department of Anaesthesiology, Institute of Medical Sciences (IMS), BHU
Varanasi
UTTAR PRADESH |
9044657889
addusingh22@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee, Faculty of Medicine, Institute of Medical Sciences, Banaras Hindu University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S063||Focal traumatic brain injury, (2) ICD-10 Condition: S069||Unspecified intracranial injury, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Balanced crystalloid |
Balanced crystaloid will be adminstered intravenously to traumatic brain injury patients |
| Comparator Agent |
Normal Saline |
Normal saline will be adminstered intravenouslyto traumatic brain injury patients |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient with nonoperative head injury admitted to intensive care unit within 24hr of injury. |
|
| ExclusionCriteria |
| Details |
1.Patient/relative refusal.
2.Patient baseline electrolytes are outside normal range.
3.Patient on inotropic support.
4.Patient with any systemic illness like Diabetes, Hypertension etc.
5.Patient with end stage organ damage e.g. hepatic, renal or cardiovascular disorder.
6.Patients with polytrauma
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Acid base and electrolyte status |
day 1, 3, 5, 7, 14 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Duration of icu stay
28 days mortality |
28 days |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/12/2018 |
| Date of Study Completion (India) |
16/03/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="5"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
1. Russell L, McLean AS. The ideal fluid. CurrOpinCrit Care. 2014;20:360–5.
2.Friedman A. Maintenance fluid therapy: what’s next. J Pediatr. 2014;165:14–5.
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The study will be conducted in ICU of trauma centre, department of anaesthesiology, IMS, BHU Varanasi after written informed consent and institutional ethical approval. After CTRI registration, 100 patients of isolated nonoperative head injury, age 18 to 60 years admitted to trauma ICU within 24hr of injury will be included. Patient will be excluded from study if baseline electrolyte are outside normal range, on ionotropic support, having systemic illness like diabetes, hypertention, patient with end organ damage, polytrauma patients and patient refusal. Patient will be divided randomly using computer generated number and concealed using sequentially numbered, sealed opaque enevelop technique into two equal groups- Group N: will receive normal saline as maintenance fluid Group B: will receive balanced crystalloids as maintenance fluid All patients will follow the ICU protocol for head injury management. A drug which affects the fluid and electrolyte status like mannitol, Diuretics etc will be recorded in both groups. Acid base status & electrolyle will be recorded on day1 , 3, 5, 7, 14 and on every 5 days there after till icu stay. Result Acid base status and electrolyte levels are better maintained in balanced crystalloid groups than normal saline and his was statically significant on day 14. No significant difference in 28 days mortality between two groups. Conclusion Balanced craystalloids can be used in traumatic brain injury patients. Further large multicentric study required to evaluate their effects on intracranial pressure. |