| CTRI Number |
CTRI/2024/10/075328 [Registered on: 15/10/2024] Trial Registered Prospectively |
| Last Modified On: |
11/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To know the benefits of different fluids (normal saline and ringers lactate) in pediatric patients with shock. |
|
Scientific Title of Study
|
To study the effectiveness of normal saline vs ringers lactate as resuscitative fluids in pediatric patients with shock . |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Fatima Huda |
| Designation |
Junior Resident |
| Affiliation |
MGM MEDICAL COLLEGE AND HOSPITAL |
| Address |
dilrus coloby , near arif colony , plot number 26, aurangabad
MGM MEDICAL COLLEGE AND HOSPIAL , room no 16, sports canteen hostel , resident quarter
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
9175423002 |
| Fax |
|
| Email |
hfmuqeet96k@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Vinod Ingale |
| Designation |
Associate Professor |
| Affiliation |
MGM MEDICAL COLLEGE AND HOSPIAL |
| Address |
plot no. 27,new chaitanya co-operative housing society, bajrang chowk , N6 , cidco , aurangabad , maharashtra
MGM MEDICAL COLLEGE AND HOSPIAL, dept of pediatrics , 3rd floor
Aurangabad
MAHARASHTRA
431005
India |
| Phone |
9823231421 |
| Fax |
|
| Email |
dr.vinodingale@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
dr vinod ingale |
| Designation |
Associate Professor |
| Affiliation |
MGM MEDICAL COLLEGE AND HOSPIAL |
| Address |
plot no. 27,new chaitanya co-operative housing society, bajrang chowk , N6 , cidco , aurangabad , maharashtra
DEPT OF PEDIATRICS , 3RD FLOOR , MGM MEDICAL COLLEGE AND HOSPITAL , AURANGABAD
MAHARASHTRA
431005
India |
| Phone |
9823231421 |
| Fax |
|
| Email |
dr.vinodingale@gmail.com |
|
|
Source of Monetary or Material Support
|
| MGM MEDICAL COLLEGE AND HOSPITAL , DEPT OF PEDIATRICS ,CIDCO N6, AURANGABAD , 431005 |
|
|
Primary Sponsor
|
| Name |
Dr Fatima Huda |
| Address |
Room no 16, Department of Pediatrics, MGM medical college ,N-6, CIDCO, AURANGABAD. |
| Type of Sponsor |
Other [{principal investigator}-(self)] |
|
|
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 |
| HUDA FATIMA |
MGM MEDICAL COLLEGE AND HOSPITAL |
MGM CASUALTY , PEDIATRIC ICU AND PEDIATRIC WARD
Aurangabad
MAHARASHTRA |
9175423002
hfmuqeet96k@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MGM-ECHRS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I998||Other disorder of circulatory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NORMAL SALINE AND RINGER LACTATE |
WE WILL ASSESS PATIENTS IN SHOCK (intervention)AND WE WILL RANDOMLY INFUSE RINGER LACTATE (interventional agent) AND NORMAL SALINE (comparator agent) AND WE WILL ASSESS OUTCOME WHICH FLUID IS BEST SUITABLE TO TREAT PATIENTS WITH SHOCK. Dose will be 10 ml per kg as bolus , and assessment will be till 24 hours |
| Intervention |
RINGER LACTATE |
WE WILLASSESS PATIENTS IN SHOCK AND WE WILL RANDOMLY INFUSE RINGER LACTATE AS A CHOICE OF FLUID |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
children included in the study which are more than 1 month upto 18 years of life presenting with shock requiring fluids resuscitation in casualty , ward or picu . |
|
| ExclusionCriteria |
| Details |
1) patients who have been diagnosed with diabetic ketoacidosis
2) patients who have been diagnosed with chronic kidney diseases
3) for patients with inborn errors of metabolism
4) children undergoing chemotherapy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary objective : to compare level of acidosis (ph and bicarbonate ) in children with shock receiving ringer lactate or normal saline as resuscitative fluid.
|
assessment will be at 0 hours ( i.e before administration of iv fluid as normal saline or ringers lactate ), 6 hours , 12 hours and 24 hours after administration of iv fluid as bolus . |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary objective : to compare: 1) metabolic response : electrolytes (sodium, chloride ,potassium) lactate, renal function tests
2) hemodynamic response :heart rate , blood pressure
3) inflammatory markers : CRP
|
Assessed from time of admission to 72 hours of intervention |
|
|
Target Sample Size
|
Total Sample Size="26"
Sample Size from India="26"
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)
|
23/10/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
To study effectiveness of normal saline vs ringers lactate as resuscitative fluids in pediatric patients with shock presenting to tertiary care hospital Aurangabad . Primary objective : To compare level of acidosis (ph. and bicarbonate ) in children with shock receiving ringer lactate or normal saline as resuscitative fluid. Secondary objective : To compare : 1) Metabolic response : Electrolytes : ( sodium , chloride , potassium ) , lactate , renal function tests 2) Hemodynamic Response : Heart rate , blood pressure 3) Inflammatory markers : CRP |