How Well do we Feed the Critically Ill Patients

Study Overview
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Brief Summary
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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
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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

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

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

Intervention / Treatment
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* Other: Nutritional therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Nutritional therapy|Either enteral or parenteral nutrition is used for the patient admitted in the ICU|

What is the study measuring?
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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 |