Back Side of the Moon: Nutritional Therapy

NCT03724045 | Completed DMC

• 1 other identifier: BUN 143201837553
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective observational follow-up of Intensive Care Unit (ICU) survivors on the adequacy of nutritional therapy: what is the mean caloric and nitrogen intake and how does their metabolic profile evolve over time? Is supplemental nutrition, in any forms, indicated to fill the caloric and protein gap? Would IV access be a barrier for SPN, and would subcutaneous parenteral nutrition be welcomed by health care practitioners and patients? Are patient centered outcomes (physical function, quality of life, performance in activities of daily living) correlated with nutritional adequacy and metabolic profile? Overall: are ICU survivors well fed after they leave ICU until hospital discharge? What kind of nutrition would possibly be useful to optimize the intake? How do their energy and protein requirements evolve? What is the physical and mental status of ICU survivors and is this correlated with nutritional status?

Conditions

Nutritional Deficiency; Hospitalism

Outcome Measures

Primary Outcomes (1)

• Morbidity

  Morbidity

  6 months after hospital discharge

Secondary Outcomes (1)

• Mortality

  6 months after hospital discharge

Study Arms (1)

Back Side of the Moon

EXPERIMENTAL

Patients will be screened and enrolled at the ICU. Extraordinary measurements concerning nutritional status will be performed, to investigate whether patients at the ICU actually meet their nutritional needs. The same patients as above will be followed up, once discharge from ICU to a low-care ward has taken place. From there, they will be followed up until discharge from the hospital. The procedures are the same as in the ICU. The results obtained at the low-care ward will be compared to those from the ICU. 6 months after hospital discharge, morbidity and mortality will be assessed. A substudy of included COVID-19 positive patients will be analysed and compared to non COVID-19 patients.

Dietary Supplement: Back Side of the Moon

Interventions

Back Side of the Moon DIETARY_SUPPLEMENT

The procedures are: several measurements will be performed, including some which are not part of the Standard Operating Procedure, hence causing it to be considered interventional. Follow-up during consultation on pneumology until max. 6 months post-admission on the ICU.

Back Side of the Moon

Eligibility Criteria

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

You may qualify if:

• ≥ 7 days ICU stay
• ≥ 7 days hospital stay

You may not qualify if:

• \< 7 days ICU stay
• metabolic disease
• restriction on nutritional therapy due to comorbid disease

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead
• Baxter Healthcare Corporation: collaborator

Study Sites (1)

UZ Brussel

Jette, 1090, Belgium

Location

Related Publications (5)

• Preiser JC, van Zanten AR, Berger MM, Biolo G, Casaer MP, Doig GS, Griffiths RD, Heyland DK, Hiesmayr M, Iapichino G, Laviano A, Pichard C, Singer P, Van den Berghe G, Wernerman J, Wischmeyer P, Vincent JL. Metabolic and nutritional support of critically ill patients: consensus and controversies. Crit Care. 2015 Jan 29;19(1):35. doi: 10.1186/s13054-015-0737-8.

  PMID: 25886997 BACKGROUND

• Wischmeyer PE. Tailoring nutrition therapy to illness and recovery. Crit Care. 2017 Dec 28;21(Suppl 3):316. doi: 10.1186/s13054-017-1906-8.

  PMID: 29297385 BACKGROUND

• Bendavid I, Singer P, Theilla M, Themessl-Huber M, Sulz I, Mouhieddine M, Schuh C, Mora B, Hiesmayr M. NutritionDay ICU: A 7 year worldwide prevalence study of nutrition practice in intensive care. Clin Nutr. 2017 Aug;36(4):1122-1129. doi: 10.1016/j.clnu.2016.07.012. Epub 2016 Aug 9.

  PMID: 27637833 BACKGROUND

• Caccialanza R, Constans T, Cotogni P, Zaloga GP, Pontes-Arruda A. Subcutaneous Infusion of Fluids for Hydration or Nutrition: A Review. JPEN J Parenter Enteral Nutr. 2018 Feb;42(2):296-307. doi: 10.1177/0148607116676593. Epub 2017 Dec 20.

  PMID: 29443395 BACKGROUND

• Lim ML, Yong BYP, Mar MQM, Ang SY, Chan MM, Lam M, Chong NCJ, Lopez V. Caring for patients on home enteral nutrition: Reported complications by home carers and perspectives of community nurses. J Clin Nurs. 2018 Jul;27(13-14):2825-2835. doi: 10.1111/jocn.14347. Epub 2018 Apr 22.

  PMID: 29518266 BACKGROUND

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Elisabeth De Waele, PhD

  Universitair Ziekenhuis Brussel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: October 26, 2018
• First Posted: October 30, 2018
• Study Start: January 1, 2019
• Primary Completion: September 28, 2021
• Study Completion: September 28, 2021
• Last Updated: October 1, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)