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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 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Sepsis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
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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