Back Side of the Moon: Nutritional Therapy
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| ClinicalTrials.gov Identifier: NCT03724045 |
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Recruitment Status :
Recruiting
First Posted : October 30, 2018
Last Update Posted : July 8, 2020
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Nutritional Deficiency Hospitalism | Dietary Supplement: Back Side of the Moon | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 50 participants |
| Intervention Model: | Sequential Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Prevention |
| 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? |
| Actual Study Start Date : | January 1, 2019 |
| Estimated Primary Completion Date : | October 1, 2021 |
| Estimated Study Completion Date : | October 1, 2021 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Back Side of the Moon
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
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. |
- Morbidity [ Time Frame: 6 months after hospital discharge ]Morbidity
- Mortality [ Time Frame: 6 months after hospital discharge ]Mortality
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03724045
| Contact: Elisabeth De Waele, PhD | +32 (0)2 477 51 76 | Elisabeth.DeWaele@uzbrussel.be |
| Belgium | |
| UZ Brussel | Recruiting |
| Jette, Belgium, 1090 | |
| Contact: Elisabeth De Waele, MD, PhD elisabeth.dewaele@uzbrussel.be | |
| Principal Investigator: | Elisabeth De Waele, PhD | Universitair Ziekenhuis Brussel |
| Responsible Party: | Elisabeth De Waele, Prof. Dr., Universitair Ziekenhuis Brussel |
| ClinicalTrials.gov Identifier: | NCT03724045 |
| Other Study ID Numbers: |
BUN 143201837553 |
| First Posted: | October 30, 2018 Key Record Dates |
| Last Update Posted: | July 8, 2020 |
| Last Verified: | March 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Plan Description: | Described in the study contract by the main sponsor: Upon completion of the Study, the INSTITUTION and INVESTIGATOR will seek to publish the results of the Study in a peer-reviewed literature. BAXTER Confidential Information shall not be disclosed without prior written permission from BAXTER. For purposes of this Agreement, "Publication" shall mean any paper, article, manuscript, report, poster, internet posting, presentation slides, abstract outline, video, instructional material, presentation (in the form of a written summary), or other public disclosure of the results of the Study, in printed, electronic, oral or other form. |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Malnutrition Nutrition Disorders |