How Well do we Feed the Critically Ill Patients

Completed

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

• Registration Number: NCT05347888
• Lead Sponsor: NMC Specialty Hospital

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 Timeline

• Study First Submitted: 2022-04-19
• Study First Submitted QC: 2022-04-23
• Study First Posted: 2022-04-26
• Study Start: 2022-08-15
• Primary Completion: 2023-08-15
• Study Completion: 2023-09-15
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-10
• Last Update Posted: 2023-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
Mortality	From the day of randomisation to 28 days of ICU admission.	Correlation between initial nutritional status and calorie and protein deficit with mortality
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
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

Trial Locations

Locations (1)

NMC Specialty Hospital, Al Nahda; 🇦🇪 Dubai, United Arab Emirates