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

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

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.

Study Overview

• Status: Completed
• Conditions: Critically Ill; Feeding Patterns; Parenteral Nutrition Associated Liver Disease; Enteral and Supplement Feeds Adverse Reaction; Nutrition Deficiency Due to Insufficient Food
• Intervention / Treatment: Other: Nutritional therapy

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 Type: Observational
• Enrollment (Actual): 1000

Contacts and Locations

Study Locations

• United Arab Emirates
  • Dubai, United Arab Emirates
    • NMC Specialty Hospital, Al Nahda

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All adult patients who are treated in the intensive care unit and receive either enteral or parenteral nutrition will be included in the study.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Calorie and protein balance	Cumulative 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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of ICU stay	Correlation between initial nutritional status and calorie and protein deficit with 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.
Days of Mechanical Ventilation	correlation between initial nutritional status and calorie and protein deficit with 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
Mortality	Correlation between initial nutritional status and calorie and protein deficit with mortality	From the day of randomisation to 28 days of ICU admission.
Time to initiation of enteral or parenteral nutrition	Time from ICU admission 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

Collaborators and Investigators

• Sponsor: NMC Specialty Hospital
• Collaborators: Govind Ballabh Pant Institute of Postgraduate Medical Education and Research; Rajiv Gandhi Cancer Institute & Research Center, India; Banaras Hindu University; Father Muller Medical College; Fortis Hospital, India; 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; Mata Chanan Devi Hospital, Delhi, India; North Eastern Indira Gandhi Regional Institute of Health ans Medical Sciences; 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

Publications and helpful links

General Publications

• Weijs PJ, Looijaard WG, Beishuizen A, Girbes AR, Oudemans-van Straaten HM. Early high protein intake is associated with low mortality and energy overfeeding with high mortality in non-septic mechanically ventilated critically ill patients. Crit Care. 2014 Dec 14;18(6):701. doi: 10.1186/s13054-014-0701-z.
• von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP; STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement: guidelines for reporting observational studies. Int J Surg. 2014 Dec;12(12):1495-9. doi: 10.1016/j.ijsu.2014.07.013. Epub 2014 Jul 18.
• Ventura AM, Waitzberg DL. Enteral nutrition protocols for critically ill patients: are they necessary? Nutr Clin Pract. 2015 Jun;30(3):351-62. doi: 10.1177/0884533614547765. Epub 2014 Sep 23.
• Bloomer MJ, Clarke AB, Morphet J. Nurses' prioritization of enteral nutrition in intensive care units: a national survey. Nurs Crit Care. 2018 May;23(3):152-158. doi: 10.1111/nicc.12284. Epub 2017 Jan 30.
• Faisy C, Lerolle N, Dachraoui F, Savard JF, Abboud I, Tadie JM, Fagon JY. Impact of energy deficit calculated by a predictive method on outcome in medical patients requiring prolonged acute mechanical ventilation. Br J Nutr. 2009 Apr;101(7):1079-87. doi: 10.1017/S0007114508055669. Epub 2008 Sep 9.
• Giner M, Laviano A, Meguid MM, Gleason JR. In 1995 a correlation between malnutrition and poor outcome in critically ill patients still exists. Nutrition. 1996 Jan;12(1):23-9. doi: 10.1016/0899-9007(95)00015-1.

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2022
• Primary Completion (Actual): August 15, 2023
• Study Completion (Actual): September 15, 2023

Study Registration Dates

• First Submitted: April 19, 2022
• First Submitted That Met QC Criteria: April 23, 2022
• First Posted (Actual): April 26, 2022

Study Record Updates

• Last Update Posted (Actual): November 14, 2023
• Last Update Submitted That Met QC Criteria: November 10, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease Attributes; Liver Diseases; Critical Illness
• Other Study ID Numbers: NMCSHFeeding

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No