Back Side of the Moon: Nutritional Therapy

Nutritional Deficiency Clinical Trial

Official title:

Back Side of the Moon Study: What is the Efficiency of Nutritional Therapy (Calories and Nitrogen) in ICU and on the Ward and What is the Metabolic Profile of Patients After ICU? Could Supplemental Nutrition Fill the Gap?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03724045
• Other study ID #: BUN 143201837553
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: September 28, 2021

Study information

• Verified date: September 2021
• Source: Universitair Ziekenhuis Brussel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

Description:

Nutritional therapy has been a matter of debate for several decades. Patient selection, time point of intervention, dosing of calories, protein, vitamins and trace elements and route of artificial nutrition have been the subject of research initiatives, and although consensus exist on several matters, some questions remain unanswered.

At the same time length of ICU stay is shortening, and ICU survivors know an extended hospital stay in the ward. The window of opportunity for adequate nutritional therapy is thereby divided between the critically ill department and the ward. Little is known on the metabolic evolution of ICU survivors, and some data support an increased protein and calorie need post resuscitation to attenuate lean body mass and promote recovery. Adequate protein and calorie delivery is required to facilitate recovery. Nevertheless, adherence to nutrition guidelines seems to be difficult in the resource-dens environment of ICU, as proven by data from the 'Nutritionday' project. Adequacy of nutritional therapy management for ICU patients that are discharged to the ward is unknown. Fair nutritional therapy could be discovered by this trial, but the possibility exists that crude iatrogenic malnutrition is discovered. This information would act as baseline data to build nutritional quality improvement programs, using different forms of artificial nutrition, from oral supplements over enteral and parenteral nutrition.

Secondly, metabolic information on ICU survivors is scarce. Body weight is often poorly followed-up, body composition evolution, including phase angle, is unknown, and metabolic monitoring by indirect calorimetry could reveal changed metabolic state and substrate use defined by the respiratory quotient.

Thirdly, relevant barriers to the use of an intravenous access have been reported: patients who are agitated or confused or where the placement and/or maintenance of an (central) IV line would cause suffering or pain. These patients show to be low in numbers, but nutrition could possibly be restrained . This raises an interesting question on the access issue. The enteral route has to be focused on, as information on patients' experience is available in home enteral nutrition, but data in post critical illness patients is non-existing. Clinical practices in the field of nutrition can be influenced by behavioral patterns of health care practitioners and patients. A questionnaire will be used to evaluate opinions of health care practitioners and patients. This information could be of value for the way we look at nutritional management.

This project targets the evaluation of nutritional adequacy on ICU and in the ward, and the observation of metabolic evolution of ICU survivors. Nutritional adequacy and metabolic profile will be investigated in correlation to patient centered outcomes (physical function, quality of life, performance in activities of daily living).

A substudy of included COVID-19 positive patients will be analysed and compared to non COVID-19 patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 28, 2021
• Est. primary completion date: September 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• = 7 days ICU stay

• = 7 days hospital stay

Exclusion Criteria:

• < 7 days ICU stay

• metabolic disease

• restriction on nutritional therapy due to comorbid disease

Related Conditions & MeSH terms

• Hospitalism
• Malnutrition
• Nutritional Deficiency

Intervention

Dietary Supplement:
• Back Side of the Moon
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.

Locations

Country	Name	City	State
Belgium	UZ Brussel	Jette

Sponsors (2)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel	Baxter Healthcare Corporation

Country where clinical trial is conducted

Belgium, 

References & Publications (5)

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. — View Citation

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. Review. — View Citation

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. — View Citation

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;19:35. doi: 10.1186/s13054-015-0737-8. Review. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morbidity	Morbidity	6 months after hospital discharge
Secondary	Mortality	Mortality	6 months after hospital discharge