| CTRI Number |
CTRI/2019/12/022391 [Registered on: 16/12/2019] Trial Registered Prospectively |
| Last Modified On: |
11/12/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Nutritional study in ICU |
|
Scientific Title of Study
|
Effect of various feeding regimen on mortality in critically ill pediatric patients of a pediatric critical care unit– A triple arm randomized control trail |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
GopalaKrishnan Ezhumalai |
| Designation |
DM, Pediatric critical care Fellow |
| Affiliation |
PGIMER, Chandigarh |
| Address |
Department of Pediatrics Advance Pediatric center
Post Graduate Institute Medical Education and Research
Chandigarh, sector 12
Department of Pediatrics Advance Pediatric center
Post Graduate Institute Medical Education and Research
Chandigarh, sector 12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
09597264165 |
| Fax |
|
| Email |
gopalgk26@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Arun Bansal |
| Designation |
Professor pediatrics |
| Affiliation |
PGIMER, Chandigarh |
| Address |
APC, PGIMER
Chandigarh, sector 12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9815455002 |
| Fax |
|
| Email |
drarunbansal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
GopalaKrishnan Ezhumalai |
| Designation |
DM, Pediatric critical care Fellow |
| Affiliation |
PGIMER, Chandigarh |
| Address |
APC, PGIMER
Chandigarh, sector 12
Chandigarh, sector 12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
09597264165 |
| Fax |
|
| Email |
gopalgk26@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate institute medical Education and Research(PGIMER)
Pediatric Intensive Care Unit
Advance Pediatric Center |
|
|
Primary Sponsor
|
| Name |
No sponsor |
| Address |
no sponsor |
| Type of Sponsor |
Other [No financial assistance ] |
|
|
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 Gopalakrishnan |
PGIMER, , APC, PICU |
Pediatric intensive care unit,
APC 2B, Advance Pediatric center,
Chandigarh, sector 12
Chandigarh
CHANDIGARH |
09597264165
gopalgk26@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, PGIMER, Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R00-R99||Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group - 3 Normocaloric normal protein |
Normal caloric based on Resting energy expenditure on schofiled equation, will be given 7 days post enrollment |
| Intervention |
Group -2 Hypercaloric normal protien |
Hyper caloric and normal protien as described, 7 days after enrollment |
| Intervention |
Group- 1 Hyopcaloric high protien
|
restricted calories and high protien as specified
7 days since enrollment |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. Septic group- All children, 6 month to 12 years old, with sepsis as per sepsis III definition
2. Non-septic group-All children, 6 month to 12 years old, without sepsis and admitted in PICU
|
|
| ExclusionCriteria |
| Details |
1.Enteral feed intolerance as defined
2. Major gastrointestinal bleed as defined
3. Protracted ileus
4.Immediate Post-operative abdominal surgery
5.Small bowel ischemia or obstruction
6.Oliguric AKI ( KIDIGO stage 3)
7. Know case of Chronic renal failure
8. Acute liver failure
9. Inborn error of metabolism
10.Diabetic ketoacidosis
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 28 day Mortality |
28 days post enrollment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Duration of PICU stay
2.Duration of hospital stay
3.Ventilator free days
4. Vasopressor free days
5. Incidence of hypo /hyperglycemia
6. Incidence of Health care associated infection
3.3.7. Incidence of AKI as per KIDIGO
8.Incidence of Transaminitis
9. Time to achieve full feeds
10. Adequacy of calories by Indirectcalorimetry
|
hospital stay and at 28 days |
|
|
Target Sample Size
|
Total Sample Size="561"
Sample Size from India="561"
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)
|
16/12/2019 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
1.Effect of study on mortality with relation to calorie and protien intake will be considered for publication
2.Effect of secondary outcomes and any adverse effect noted during the trail |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a triple arm randomized trial planned in critically ill children going to get admitted in tertiary level Pediatric Intensive Care Unit. This trial wants to study the effect of various feeding protocols in terms of normocaloric normal protien, Hypocaloric high protien, Hypercaloric high protien diet on 28 day mortality the rationale for this study is that there providing high protien restricted calories during initial period of critical illness prevents autophagy and improves outcome our study will be based on schofield equation ( recomnended by ASPEN 2018) Energy requirement in critically ill children |