Clinical trial NCT05347888: How Well do we Feed the Critically Ill Patients
Official title: How Well do we Feed the Critically Ill Patients: a Multicentric, Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Enteral and Supplement Feeds Adverse Reaction
Nutrition Deficiency Due to Insufficient Food
Critically Ill
Parenteral Nutrition Associated Liver Disease
Feeding Patterns
Lead sponsor: NMC Specialty Hospital
Sponsor class: OTHER
Collaborators: name: Banaras Hindu University
name: All India Institute of Medical Sciences
name: All India Institute of Medical Sciences, Raipur
name: Artemis Hospital, Gurugram, India
name: Atal Bihari Vajpayee Institute of Medical Sciences and Dr RML Hospital, Delhi, India
name: Dr Bhubaneswar Borooah Cancer Hospital, Guwahati, India
name: Father Muller Medical College
name: Fortis Hospital, India
name: Govind Ballabh Pant Institute of Postgraduate Medical Education and Research
name: Mata Chanan Devi Hospital, Delhi, India
name: North Eastern Indira Gandhi Regional Institute of Health ans Medical Sciences
name: Rajiv Gandhi Cancer Institute & Research Center, India
name: Mediclinic Parkview Hospital, Dubai, United Arab Emirates
name: Amina Hospital, Ajman, United Arab Emirates
name: Sri Guru Ram Institute of Medical & Health Science Shri Mahant Indiresh Hospital, Dehradun, India
First posted: 2022-04-26
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

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.

Primary outcomes:
measure: Calorie and protein balance
timeFrame: From day of randomization till 7 days, or the patient is discharged from ICU, or death of the patient, whichever is earlier.
Secondary outcomes:
measure: Length of ICU stay
timeFrame: 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.
measure: Days of Mechanical Ventilation
timeFrame: 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
measure: Mortality
timeFrame: From the day of randomisation to 28 days of ICU admission.
measure: Time to initiation of enteral or parenteral nutrition
timeFrame: From the day of randomisation till 28 days of ICU admission, or death of the patient, whichever is earlier
Other outcomes:
Locations:
city: Dubai
country: United Arab Emirates
facility: NMC Specialty Hospital, Al Nahda
Study officials:
affiliation: Artemis Hospital, Gurugram, India
name: Saurabh K Das, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
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: 10.1017/S0007114508055669. Epub 2008 Sep 9.
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.
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;12(12):1495-9. doi: 10.1016/j.ijsu.2014.07.013. Epub 2014 Jul 18.