How Well do we Feed the Critically Ill Patients

Critically Ill Clinical Trial

— WE-FEED  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05347888
• Other study ID #: NMCSHFeeding
• Status: Completed
• Start date: August 15, 2022
• Est. completion date: September 15, 2023

Study information

• Verified date: November 2023
• Source: NMC Specialty Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: September 15, 2023
• Est. primary completion date: August 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Critical Illness
• Critically Ill
• Feeding Patterns
• Liver Diseases
• Nutrition Deficiency Due to Insufficient Food
• Parenteral Nutrition Associated Liver Disease

Intervention

Other:
• Nutritional therapy
Either enteral or parenteral nutrition is used for the patient admitted in the ICU

Locations

Country	Name	City	State
United Arab Emirates	NMC Specialty Hospital, Al Nahda	Dubai

Sponsors (16)

Lead Sponsor

Collaborator

NMC Specialty Hospital

All India Institute of Medical Science, Guntur, All India Institute of Medical Science, Raipur, India, 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

Country where clinical trial is conducted

United Arab Emirates, 

References & Publications (6)

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. — View Citation

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: — View Citation

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. — View Citation

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. — View Citation

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;1 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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
Secondary	Mortality	Correlation between initial nutritional status and calorie and protein deficit with mortality	From the day of randomisation to 28 days of ICU admission.
Secondary	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