How Well do we Feed the Critically Ill Patients

NCT05347888 | Completed

• 1 other identifier: NMCSHFeeding
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

  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

  From the day of randomisation to 28 days of ICU admission.

• 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

Interventions

Nutritional therapy OTHER

Either enteral or parenteral nutrition is used for the patient admitted in the ICU

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• All adult patients who receive either enteral or parenteral nutrition will be included in the study.

You may not qualify if:

• Age less than 18 years old
• Pregnant women
• Patient is expected to die within 48 hours of ICU admission.

Sponsors & Collaborators

• NMC Specialty Hospital: lead
• Banaras Hindu University: collaborator
• All India Institute of Medical Sciences: collaborator
• All India Institute of Medical Sciences, Raipur: collaborator
• Artemis Hospital, Gurugram, India: collaborator
• Atal Bihari Vajpayee Institute of Medical Sciences and Dr RML Hospital, Delhi, India: collaborator
• Dr Bhubaneswar Borooah Cancer Hospital, Guwahati, India: collaborator
• Father Muller Medical College: collaborator
• Fortis Hospital, India: collaborator
• Govind Ballabh Pant Institute of Postgraduate Medical Education and Research: collaborator
• Mata Chanan Devi Hospital, Delhi, India: collaborator
• North Eastern Indira Gandhi Regional Institute of Health ans Medical Sciences: collaborator
• Rajiv Gandhi Cancer Institute & Research Center, India: collaborator
• Mediclinic Parkview Hospital, Dubai, United Arab Emirates: collaborator
• Amina Hospital, Ajman, United Arab Emirates: collaborator
• Sri Guru Ram Institute of Medical & Health Science Shri Mahant Indiresh Hospital, Dehradun, India: collaborator

Study Sites (1)

NMC Specialty Hospital, Al Nahda

Dubai, United Arab Emirates

Location

Related 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.

  PMID: 28133862 BACKGROUND

• 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.

  PMID: 25249598 BACKGROUND

• 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.

  PMID: 25499096 BACKGROUND

• 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.

  PMID: 18778528 RESULT

• 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.

  PMID: 8838832 RESULT

• 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.

  PMID: 25046131 RESULT

MeSH Terms

Conditions

Critical Illness; Feeding Behavior

Interventions

Nutrition Therapy

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior, Animal; Behavior

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Saurabh K Das, MD

  Artemis Hospital, Gurugram, India

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: HOD, Critical Care Medicine

Study Record Dates

• First Submitted: April 19, 2022
• First Posted: April 26, 2022
• Study Start: August 15, 2022
• Primary Completion: August 15, 2023
• Study Completion: September 15, 2023
• Last Updated: November 14, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

AE (1)