WE-FEED: How Well do we Feed the Critically Ill Patients

Sponsor
NMC Specialty Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05347888
Collaborator
Banaras Hindu University (Other), All India Institute of Medical Science, Guntur (Other), All India Institute of Medical Science, Raipur, India (Other), Artemis Hospital, Gurugram, India (Other), Atal Bihari Vajpayee Institute of Medical Sciences and Dr RML Hospital, Delhi, India (Other), Dr Bhubaneswar Borooah Cancer Hospital, Guwahati, India (Other), Father Muller Medical College (Other), Fortis Hospital, India (Other), Govind Ballabh Pant Institute of Postgraduate Medical Education and Research (Other), Mata Chanan Devi Hospital, Delhi, India (Other), North Eastern Indira Gandhi Regional Institute of Health ans Medical Sciences (Other), Rajiv Gandhi Cancer Institute & Research Center, India (Other), Mediclinic Parkview Hospital, Dubai, United Arab Emirates (Other), Amina Hospital, Ajman, United Arab Emirates (Other), Sri Guru Ram Institute of Medical & Health Science Shri Mahant Indiresh Hospital, Dehradun, India (Other)
1,000
1
8
125.3

Study Details

Study Description

Brief Summary

The present prospective observational multicentric study will assess the nutritional status of critically ill patients, cumulative calorie and protein balance and the effect of calorie and protein balance on clinical outcomes.

Detailed Description

Nutritional therapy is a very important aspect of the management of critically ill patients. These patients need intensive monitoring, various organ supports in the form of vasopressors and inotropes, mechanical ventilation, dialysis, extracorporeal organ supports, infection controls, etc. In this very complex, critical and demanding scenario, nutritional therapy often gets a back seat in the initial period at least till the time patient is stabilised. But this nutritional deprivation has much more deleterious effects in sepsis and systemic inflammatory response syndromes induced catabolic state than that of fasting in healthy persons. Various studies showed that inadequate feeding has been associated with an increased hospital length of stay, incidence of complications, infections, incidence of organ failure, and risk of mortality. A single centre prospective study that analyzed 768 patients reported that 69% were calorie deficient and 90% were protein deficient. They also observed a positive correlation between calorie deficit and infectious complications, length of Intensive Care Unit (ICU) stay and days of mechanical ventilation.

The main factors may hinder enteral feeding and adequate nutrition delivery. That includes delay in the initiation of Enteral Nutrition (EN) and slow infusion rate; low adherence to EN practice guidelines; frequent disruptions to EN due to diagnostic or therapeutic procedures.

In observational studies, patients in the ICU who were fed early through the enteral route have had a better outcome than those who were not. Similarly, overfeeding has also been associated with various complications, including hyperglycemia, hypertriglyceridemia, hepatic steatosis, azotemia, hypercapnia, and an increased rate of mortality among patients.

Therefore, optimum nutrition is vital to a patient's survival. The present prospective observational multicentric study will assess the nutritional status of critically ill patients, cumulative calorie and protein balance and the effect of calorie and protein balance on clinical outcome

Study Design

Study Type:
Observational
Anticipated Enrollment :
1000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
How Well do we Feed the Critically Ill Patients: a Multicentric, Prospective Observational Study
Anticipated Study Start Date :
Jul 15, 2022
Anticipated Primary Completion Date :
Dec 15, 2022
Anticipated Study Completion Date :
Mar 15, 2023

Outcome Measures

Primary Outcome Measures

  1. Calorie and protein balance [From day of randomization till 7 days, or the patient is discharged from ICU, or death of the patient, whichever is earlier.]

    Cumulative calorie and protein balance.

Secondary Outcome Measures

  1. Length of ICU stay [From the day of randomization till the patient is shifted out of ICU, or death of the patient, or 28 days of ICU admission, whichever is earlier.]

    Correlation between initial nutritional status and calorie and protein deficit with length of ICU stay

  2. Days of Mechanical Ventilation [From day of randomization till the patient is removed from mechanical ventilation, or 28 days of ICU admission, or death of the patient, whichever is earlier]

    correlation between initial nutritional status and calorie and protein deficit with days of mechanical ventilation

  3. Mortality [From the day of randomisation to 28 days of ICU admission.]

    Correlation between initial nutritional status and calorie and protein deficit with mortality

  4. Time to initiation of enteral or parenteral nutrition [From the day of randomisation till 28 days of ICU admission, or death of the patient, whichever is earlier]

    Time from ICU admission to initiation of enteral or parenteral nutrition

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • All adult patients who receive either enteral or parenteral nutrition will be included in the study.
Exclusion Criteria:
  • Age less than 18 years old

  • Pregnant women

  • Patient is expected to die within 48 hours of ICU admission.

Contacts and Locations

Locations

Site City State Country Postal Code
1 NMC Specialty Hospital, Al Nahda Dubai United Arab Emirates

Sponsors and Collaborators

  • NMC Specialty Hospital
  • Banaras Hindu University
  • All India Institute of Medical Science, Guntur
  • All India Institute of Medical Science, Raipur, India
  • Artemis Hospital, Gurugram, India
  • Atal Bihari Vajpayee Institute of Medical Sciences and Dr RML Hospital, Delhi, India
  • Dr Bhubaneswar Borooah Cancer Hospital, Guwahati, India
  • Father Muller Medical College
  • Fortis Hospital, India
  • Govind Ballabh Pant Institute of Postgraduate Medical Education and Research
  • Mata Chanan Devi Hospital, Delhi, India
  • North Eastern Indira Gandhi Regional Institute of Health ans Medical Sciences
  • Rajiv Gandhi Cancer Institute & Research Center, India
  • Mediclinic Parkview Hospital, Dubai, United Arab Emirates
  • Amina Hospital, Ajman, United Arab Emirates
  • Sri Guru Ram Institute of Medical & Health Science Shri Mahant Indiresh Hospital, Dehradun, India

Investigators

  • Principal Investigator: Saurabh K Das, MD, Artemis Hospital, Gurugram, India

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Prashant Nasa, HOD, Critical Care Medicine, NMC Specialty Hospital
ClinicalTrials.gov Identifier:
NCT05347888
Other Study ID Numbers:
  • NMCSHFeeding
First Posted:
Apr 26, 2022
Last Update Posted:
Apr 26, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 26, 2022