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Clinical Trials/NCT05347888
NCT05347888
Completed
Not Applicable

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

NMC Specialty Hospital1 site in 1 country1,000 target enrollmentAugust 15, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Enteral and Supplement Feeds Adverse Reaction
Sponsor
NMC Specialty Hospital
Enrollment
1000
Locations
1
Primary Endpoint
Calorie and protein balance
Status
Completed
Last Updated
2 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
August 15, 2022
End Date
September 15, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Prashant Nasa

HOD, Critical Care Medicine

NMC Specialty Hospital

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

  • 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.)
  • Mortality(From the day of randomisation to 28 days of ICU admission.)
  • 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)
  • 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)

Study Sites (1)

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