Skip to content

How Well do we Feed the Critically Ill Patients

How Well do we Feed the Critically Ill Patients: a Multicentric, Prospective Observational Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05347888
Acronym
WE-FEED
Enrollment
1000
Registered
2022-04-26
Start date
2022-08-15
Completion date
2023-09-15
Last updated
2023-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Enteral and Supplement Feeds Adverse Reaction, Nutrition Deficiency Due to Insufficient Food, Critically Ill, Parenteral Nutrition Associated Liver Disease, Feeding Patterns

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

Interventions

Either enteral or parenteral nutrition is used for the patient admitted in the ICU

Sponsors

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

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
Calorie and protein balanceFrom 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

MeasureTime frameDescription
Length of ICU stayFrom 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
Days of Mechanical VentilationFrom day of randomization till the patient is removed from mechanical ventilation, or 28 days of ICU admission, or death of the patient, whichever is earliercorrelation between initial nutritional status and calorie and protein deficit with days of mechanical ventilation
MortalityFrom the day of randomisation to 28 days of ICU admission.Correlation between initial nutritional status and calorie and protein deficit with mortality
Time to initiation of enteral or parenteral nutritionFrom the day of randomisation till 28 days of ICU admission, or death of the patient, whichever is earlierTime from ICU admission to initiation of enteral or parenteral nutrition

Countries

United Arab Emirates

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026