| CTRI Number |
CTRI/2020/10/028620 [Registered on: 26/10/2020] Trial Registered Prospectively |
| Last Modified On: |
06/10/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of two different type of fluid (normal saline versus balanced solution) in emergency neurosurgical patients. |
|
Scientific Title of Study
|
COMPARISON OF NORMAL SALINE AND BALANCED CRYSTALLOID SOLUTION ON ACID BASE AND ELECTROLYTE STATUS IN EMERGENCY NEUROSURGICAL TRAUMA PATIENTS - A PROSPECTIVE RANDOMISED 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 AMBUJ GIRI |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Institute of medical sciences, Banaras Hindu University |
| Address |
Shushruta Boys Hostel,Trauma Centre,Banaras Hindu University, Varanasi, Uttar Pradesh.
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8981352433 |
| Fax |
|
| Email |
Ambuj.giri19@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr YASHPAL SINGH |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
Institute of medical sciences, Banaras Hindu University |
| Address |
Sir Sunderlal Hospital,Banaras Hindu University, Varanasi, Uttar Pradesh.
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9918424416 |
| Fax |
|
| Email |
dryashacin1999@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr YASHPAL SINGH |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
Institute of medical sciences, Banaras Hindu University |
| Address |
Sir Sunderlal Hospital,Banaras Hindu University, Varanasi, Uttar Pradesh.
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9918424416 |
| Fax |
|
| Email |
dryashacin1999@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of medical sciences, Banaras Hindu University..
Lanka, Varanasi, Uttar Pradesh..
Varanasi-221005 |
|
|
Primary Sponsor
|
| Name |
Trauma Centre Banaras Hindu University |
| Address |
Trauma Centre, Banaras Hindu University, Varanasi, Uttar Pradesh.. |
| 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 Ambuj Giri |
Trauma Centre,Banaras Hindu University |
Bhagwanpur Lanka, Varanasi,Uttar Pradesh..
Varanasi-221005
Varanasi
UTTAR PRADESH |
8981352433
Ambuj.giri19@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute of medical sciences, Banaras Hindu University Ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S068||Other specified intracranial injuries, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Balanced crystalloid |
Balanced crystalloids will be administered to emergency neurosurgical patients posted for emergency neurosurgery. |
| Comparator Agent |
Normal Saline |
Normal Saline will be administered to emergency neurosurgical patient posted for neurosurgery in trauma emergency. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Age group between 18 and 60 years.
2.Traumatic neurosurgical emergency patients posted for decompressive craniotomy.
3.Patients received from emergency of trauma centre with in 24hrs of injury after resuscitation. |
|
| 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.
5. Patient with end stage organ damage e.g. hepatic,renal or cardiovascular disorder.
6. Patient with polytrauma. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Acid base and electrolyte status |
Preoperative, at end of surgery before extubation and 6 hr. postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 3 |
|
Date of First Enrollment (India)
|
19/11/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
19/11/2020 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not Specified/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 is a prospective randomized double-blind study were patient population will be divided in two groups and we will be comparing normal saline and balanced crystalloid solutions..
We will look after the effects of above mentioned fluids on acid base and serum electrolyte status.. |