| CTRI Number |
CTRI/2017/10/010106 [Registered on: 16/10/2017] Trial Registered Prospectively |
| Last Modified On: |
14/10/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Important of adequate nutrients by tube feed in hospitalized with severe infectious patients |
|
Scientific Title of Study
|
Effect of enteral nutrition delivery on clinical outcome in critically ill sepsis patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Pr Protocol No 1.0 Version No 1.0 Dated 31/01/2017 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manoj Rai |
| Designation |
Sr. Consultant, MD |
| Affiliation |
Apollo Hospitals Bilaspur |
| Address |
Department of Internal Medicine and Intensive Care,Apollo Hospitals Bilaspur, Seepat Road, Lingiadih Village
Bilaspur CHHATTISGARH 495006 India |
| Phone |
9755550857 |
| Fax |
|
| Email |
manojraik@yahoo.com |
|
Details of Contact Person Scientific Query
|
| Name |
Shalini Soren |
| Designation |
Clinical Dietitian |
| Affiliation |
Apollo Hospitals Bilaspur |
| Address |
Department of Dietetics,Apollo Hospitals Bilaspur, Seepat Road, Lingiadih Village
Bilaspur CHHATTISGARH 495006 India |
| Phone |
9630822477 |
| Fax |
|
| Email |
shalinisoren.19@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Zubaid Khan |
| Designation |
RMO |
| Affiliation |
Apollo Hospitals Bilaspur |
| Address |
Department of Intensive care unit,Apollo Hospitals Bilaspur, Seepat Road, Lingiadih Village,
Bilaspur CHHATTISGARH 495006 India |
| Phone |
9179960058 |
| Fax |
|
| Email |
drzubaidkhan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Apollo Hospitals Bilaspur, Seepat Road, Lingiadih Village, Bilaspur, Chhattisgarh, India- 495006 |
|
|
Primary Sponsor
|
| Name |
Apollo Hospitals Bilaspur |
| Address |
Seepat Road, Lingiadih Village, Bilaspur, Chhattisgarh, India- 495006 |
| Type of Sponsor |
Research institution and hospital |
|
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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 Manoj Rai |
Apollo Hospitals Bilaspur |
Department of Internal Medicine and Intensive Care,2nd Floor,Intensive Care Unit,Apollo Hospitals Bilaspur Bilaspur CHHATTISGARH |
9755550857
manojraik@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee Apollo Hospitals Bilaspur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Sepsis, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
95.00 Year(s) |
| Gender |
Both |
| Details |
1. Who will receive enteral nutrition via tube feeding
2. Patients having diagnosis of sepsis ( Sepsis -3 guidelines)
|
|
| ExclusionCriteria |
| Details |
1. Below 18 years of age.
2. Who will receive Parentral Nutrition
3. Oral Diet
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of energy and protein amount received by enteral nutrition on clinical outcomes in critically ill sepsis patients in intensive care unit |
Amount of energy and protein will be continuously monitored and recorded at following time
1. Starting early within 24-48 hours after ICU admission
2. Enteral nutrition delivery will be follow to a maximum of 7 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Duration of organ support(mechanicalventilator/NIV/dialysis/vasopressors), length of ICU stay, length of hospital stay, and mortality |
Duration of organ support(mechanicalventilator/NIV/dialysis/vasopressors), length of ICU stay, length of hospital stay, and mortality will be monitored and recorded at following time
1. 24 hours ICU admission
2. 30 days of ICU stay |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
01/11/2017 |
| 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="0" Months="7" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Critically ill patients are characterized by marked variations in energy requirements and net protein catabolism due to disproportional cytokine and stress hormone release. These patients are prone to develop energy and protein deficits over their time of ICU stay, as they are unable to resume oral feeds. To prevent adverse outcomes related to nutritional deficits such as increased infectious complications, nutrition support is warranted. Current guidelines uniformly recommended enteral nutrition as first line therapy, starting early within 48 hrs after ICU admission. Early enteral nutrition has thereby several non-nutritional benefits such as supporting the immune and metabolic responses as well as preserving gut integrity. However, it is still less clear what the optimal dose of enteral nutrition should be, particularly during the first week of illness, and how critically ill sepsis patients respond to the amount of energy and protein receiveby enteral nutrition. Aim-To evaluate the effect of energy and protein amount received by enteral nutrition on clinical outcomes i.e. need and duration of organ support (mechanicalventilator/NIV/dialysis/vasopressors), length of ICU stay, length of hospital stay, and mortality in critically ill sepsis patients in intensive care unit. Design- Prospective, Observational, Cohort Study. Methods -100 patients data will be collected daily from the date of admission to a maximum of 7 days. The patient data required will include: diagnosis (sepsis origin), sex, age, height, weight, baseline APACHE II score, SOFA score, Nutric score, amount of enteral nutrition delivery , enteral nutrition administration, monitoring of organ support ( dose of vasopressors , type of dialysis, duration of mechanical ventilation and NIV). Patients will be followed up to record length of mechanical ventilation, length of ICU and hospital stay and mortality. Statistical analysis will be done after completion of data.
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