Enteral and Supplement Feeds Adverse ReactionWE-FEEDNCT05347888
How Well do we Feed the Critically Ill Patients
An observational study of Enteral and Supplement Feeds Adverse Reaction and Nutrition Deficiency Due to Insufficient Food, run by NMC Specialty Hospital at 1 site in United Arab Emirates.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Enteral and Supplement Feeds Adverse Reaction, Nutrition Deficiency Due to Insufficient Food, Critically Ill
- What is being tested?
- Nutritional therapy
- How many people
- 1,000 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 15 Aug 2022to 15 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- All adult patients who receive either enteral or parenteral nutrition will be included in the study.
Who cannot join
- Age less than 18 years old
- Pregnant women
- Patient is expected to die within 48 hours of ICU admission.
Trial locations and contacts
1 site in 1 country.
United Arab Emirates1 site
NMC Specialty Hospital, Al Nahda
Dubai
About this study
Official title: How Well do we Feed the Critically Ill Patients: a Multicentric, Prospective Observational Study
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.
Read the 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
- Conditions
- Enteral and Supplement Feeds Adverse Reaction, Nutrition Deficiency Due to Insufficient Food, Critically Ill, Parenteral Nutrition Associated Liver Disease, Feeding Patterns
- Being tested
- Nutritional therapy
- Medical subject headings
- Critical Illness, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional therapyOther
Either enteral or parenteral nutrition is used for the patient admitted in the ICU
What is being measured
The primary outcome is the main question the study is designed to answer.
Calorie and protein balance
Cumulative calorie and protein balance.
Measured: 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
Correlation between initial nutritional status and calorie and protein deficit with length of ICU stay
Measured: 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
Measured: 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
Measured: 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
Measured: From the day of randomisation till 28 days of ICU admission, or death of the patient, whichever is earlier
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start15 Aug 2022
- Primary completion15 Aug 2023
- Study completion15 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Enteral and Supplement Feeds Adverse ReactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- NMC Specialty Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Banaras Hindu University, All India Institute of Medical Sciences, All India Institute of Medical Sciences, Raipur, Artemis Hospital, Gurugram, India, Atal Bihari Vajpayee Institute of Medical Sciences and Dr RML Hospital, Delhi, India, Dr Bhubaneswar Borooah Cancer Hospital, Guwahati, India, Father Muller Medical College, Fortis Hospital, India, Govind Ballabh Pant Institute of Postgraduate Medical Education and Research, Mata Chanan Devi Hospital, Delhi, India, North Eastern Indira Gandhi Regional Institute of Health ans Medical Sciences, Rajiv Gandhi Cancer Institute & Research Center, India, Mediclinic Parkview Hospital, Dubai, United Arab Emirates, Amina Hospital, Ajman, United Arab Emirates, Sri Guru Ram Institute of Medical & Health Science Shri Mahant Indiresh Hospital, Dehradun, India
- Responsible party
- Principal investigator, Prashant Nasa, NMC Specialty Hospital
- Investigators
- Saurabh K Das, MD, Principal investigator, Artemis Hospital, Gurugram, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05347888
- Sponsor's protocol ID
- NMCSHFeeding
- Acronym
- WE-FEED
- Status last verified
- Nov 2023
- First submitted
- 19 Apr 2022
- Last updated
- 14 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28133862Ventura 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.
PubMed 25249598Weijs 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.
PubMed 25499096Faisy 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.
PubMed 18778528Giner 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.
PubMed 8838832von 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.
PubMed 25046131
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Well do we Feed the Critically Ill Patients: a Multicentric, Prospective Observational Study
- ClinicalTrials.gov ID
- NCT05347888
- Acronym / sponsor ID
- WE-FEED / NMCSHFeeding
- Conditions
- Enteral and Supplement Feeds Adverse Reaction, Nutrition Deficiency Due to Insufficient Food, Critically Ill, Parenteral Nutrition Associated Liver Disease, Feeding Patterns
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- NMC Specialty HospitalUniversity, hospital or other
- Collaborators
- Banaras Hindu University, All India Institute of Medical Sciences, All India Institute of Medical Sciences, Raipur, Artemis Hospital, Gurugram, India, Atal Bihari Vajpayee Institute of Medical Sciences and Dr RML Hospital, Delhi, India, Dr Bhubaneswar Borooah Cancer Hospital, Guwahati, India, Father Muller Medical College, Fortis Hospital, India, Govind Ballabh Pant Institute of Postgraduate Medical Education and Research, Mata Chanan Devi Hospital, Delhi, India, North Eastern Indira Gandhi Regional Institute of Health ans Medical Sciences, Rajiv Gandhi Cancer Institute & Research Center, India, Mediclinic Parkview Hospital, Dubai, United Arab Emirates, Amina Hospital, Ajman, United Arab Emirates, Sri Guru Ram Institute of Medical & Health Science Shri Mahant Indiresh Hospital, Dehradun, India
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- 15 Aug 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 26 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- All adult patients who receive either enteral or parenteral nutrition will be included in the study.
Key exclusion criteria (3 listed)
- Age less than 18 years old
- Pregnant women
- Patient is expected to die within 48 hours of ICU admission.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutritional therapyEither enteral or parenteral nutrition is used for the patient admitted in the ICU | Other | – |
Primary outcome
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.
4 secondary outcomes
Length of ICU stay
Time frame: 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
Time frame: 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
Time frame: From the day of randomisation to 28 days of ICU admission.
Time to initiation of enteral or parenteral nutrition
Time frame: From the day of randomisation till 28 days of ICU admission, or death of the patient, whichever is earlier
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2023.
- Background: PubMed 28133862Bloomer 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.
- Background: PubMed 25249598Ventura 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.
- Background: PubMed 25499096Weijs 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.
- Results publication: PubMed 18778528Faisy 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.
- Results publication: PubMed 8838832Giner 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.
- Results publication: PubMed 25046131von 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saurabh K Das, MD principal investigator
Artemis Hospital, Gurugram, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Enteral and Supplement Feeds Adverse Reaction and Nutrition Deficiency Due to Insufficient Food, run by NMC Specialty Hospital at 1 site in United Arab Emirates.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05347888, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2023.