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NCT Number: NCT05347888

How Well do we Feed the Critically Ill Patients

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.

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Key information

Conditions

Enteral and Supplement Feeds Adverse Reaction Behavior Behavior, Animal Critical Illness Critically Ill Disease Attributes Feeding Behavior Feeding Patterns Nutrition Deficiency Due to Insufficient Food Parenteral Nutrition Associated Liver Disease Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

NMC Specialty Hospital, Al Nahda

Dubai, United Arab Emirates

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nutritional therapy

Other

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

Primary outcomes

  1. Calorie and protein balance

    Time frame: 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 outcomes

  1. Length of ICU stay

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

NMC Specialty Hospital

Other

Collaborators

  • All India Institute of Medical Sciences
  • All India Institute of Medical Sciences, Raipur
  • Amina Hospital, Ajman, United Arab Emirates
  • Artemis Hospital, Gurugram, India
  • Atal Bihari Vajpayee Institute of Medical Sciences and Dr RML Hospital, Delhi, India
  • Banaras Hindu University
  • 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
  • Mediclinic Parkview Hospital, Dubai, United Arab Emirates
  • North Eastern Indira Gandhi Regional Institute of Health ans Medical Sciences
  • Rajiv Gandhi Cancer Institute & Research Center, India
  • Sri Guru Ram Institute of Medical & Health Science Shri Mahant Indiresh Hospital, Dehradun, India

Registry information

Official study title

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

Acronym: WE-FEED

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 26, 2022
Registry last updated
Nov 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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