- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06923813
Assessment of Nutrient Absorption in Enterally Fed Post-intensive Care Unit Patients Using Bomb Calorimetry: do the Calories Stick (STICKY)
Assessment of Nutrient Absorption in Enterally Fed Post-ICU Patients Using Bomb Calorimetry: do the Calories Stick
This study focuses on understanding how well patients who have recovered from an ICU stay absorb nutrients when receiving enteral (tube) feeding. Proper nutrition is crucial for recovery, but we don't fully understand how efficiently enteral feeding works in ICU survivors. The study will use advanced techniques like bomb calorimetry to measure the energy content of stool, and indirect calorimetry to measure patients' resting energy expenditure (REE). This will help assess the effectiveness of enteral feeding in these patients, providing valuable information about their metabolic needs and nutritional status.
The study will also look into the environmental impact of enteral feeding, particularly food waste. By understanding how much of the nutrition is absorbed versus excreted, the study hopes to suggest more sustainable feeding practices and reduce unnecessary waste in hospitals.
Key Goals:
- Primary Goal: Measure how much energy from enteral feeding is absorbed by patients post-ICU by analyzing their stool and energy expenditure.
- Secondary Goal: Assess how enteral feeding can be made more sustainable, with less waste generated from unused nutritional products.
This research will help improve nutritional care for ICU patients, enhance recovery, and potentially lead to more environmentally friendly healthcare practices.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study investigates the absorption efficiency of enteral nutrition in patients recovering from an intensive care unit (ICU) stay. Nutritional support is critical in the recovery of ICU patients, and enteral feeding is commonly used due to its benefits in preserving gut integrity and reducing infection risks. However, there is limited data on the actual absorption of nutrients in these patients, particularly in terms of how much of the provided energy is utilized versus excreted.
The primary focus of this study is to quantify the caloric intake and the caloric content of excreted stool to determine the efficiency of nutrient absorption in post-ICU patients. This will be done using bomb calorimetry, which measures the energy content in stool samples, and indirect calorimetry to assess the patients' resting energy expenditure (REE).
The study design is prospective, interventional, and single-center, involving 20 post-ICU patients who meet the inclusion criteria. Detailed tracking of caloric intake, including both enteral feeding and supplemental infusion calories, will be performed daily. Stool samples will be collected for three days, with the nonabsorbable blue dye marker method used to track the specific stool produced during this period. These stool samples will be freeze-dried, formed into pellets, and analyzed using the Parr 6200 Isoperibol Calorimeter to measure their energy content.
The secondary objective is to evaluate the sustainability of enteral feeding practices by assessing the amount of waste generated, such as unused nutritional formulas and tubing. This includes quantifying food waste in the hospital, focusing on nutrition that is not consumed, absorbed, or excreted.
By understanding the actual energy absorption in ICU survivors, this study aims to provide insights that will optimize nutritional strategies, improve patient recovery, and contribute to cost-effective, environmentally sustainable healthcare practices.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Elisabeth De Waele
- Phone Number: 02476 3354
- Email: Elisabeth.DeWaele@uzbrussel.be
Study Locations
-
-
-
Brussels, Belgium
- Not yet recruiting
- UZ Brussel
-
Contact:
- UZ Brussel
- Phone Number: 024776001
- Email: virgini.vanbuggenhout@uzbrussel.be
-
Jette, Belgium, 1090
- Recruiting
- UZ Brussel
-
Contact:
- Maridi Aerts
- Phone Number: +3224776011
- Email: maridi.aerts@uzbrussel.be
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- age of 18 years or older
- minimum ICU stay of 7 days
- fully dependent on enteral feeding (nasogastric or PEG-tube)
- ability of the patient or representative to understand and sign written informed consent in Dutch, French or English
Exclusion Criteria:
- known inflammatory bowel disease
- known malabsorptive gastrointestinal disease
- history of small bowel resection
- concomitant use of serotoninergic or sympathomimetic medications (oa. setrone, tryptans, antidepressants, methylphenidate, monoamine oxidase inhibitors, tramadol)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Participants
20 post-ICU patients who are fully enterally fed (PEG- or nasogastric tube).
Step-by-Step Process: Every time a patient is included, all steps (caloric intake measurement, stool sample collection, blending, freezing, and freeze drying) will be performed sequentially.
Bomb Calorimetry can be conducted either systematicallyfor a few patients at a time or all at once after all samples have been collected.
|
Detailed daily tracking of the enteral feeding provided to each patient, inclusing the type and amount of nutritional formula administered.
Apart from the enteral intake, supplemental calories provided by infusion (e.g.
glucose) will be recorded to ensure accurate measurement of caloric intake.
performing indirect calorimetry to measure the REE of each patient
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
caloric absorption efficiency
Time Frame: From screening to study completion for the patient, on average 3 days
|
the caloric intake from enteral feeding will be compared with the caloric content of the excreted stool.
The difference between these two values will provide an estimate of how efficiently the body absorbs the administered nutrients.
|
From screening to study completion for the patient, on average 3 days
|
|
Resting Energy Expenditure (REE)
Time Frame: From screening to study completion for the patient, on average 3 days
|
The study will measure the resting energy expenditure of post-ICU patients using indirect calorimetry, which provides a real-time measure of the patients' basal metabolic rate and energy needs.
|
From screening to study completion for the patient, on average 3 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Nutrient Absorption Efficiency
Time Frame: From screening to study completion for the patient, on average 3 days
|
The proportion of the enteral nutrition that is absorbed by the patient will be compared to the total amount administered.
A higher absorption efficiency would suggest less wasted nutrition and better utilization of the enteral feeding.
|
From screening to study completion for the patient, on average 3 days
|
|
Waste Generation from Enteral Feeding Solutions and Tubing
Time Frame: From screening to study completion for the patient, on average 3 days
|
The study will evaluate the quantity of waste produced from the daily replacement of enteral feeding solutions and tubing.
This measure will provide insight into the sustainability impact of current practices and how much material is being discarded in hospital settings.
|
From screening to study completion for the patient, on average 3 days
|
|
Overall Food Waste in Hospitals
Time Frame: From screening to study completion for the patient, on average 3 days
|
The study will quantify the amount of enteral nutrition that is not consumed, absorbed, or excreted.
This includes any nutrition that is wasted due to feeding inefficiencies or patient non-consumption.
|
From screening to study completion for the patient, on average 3 days
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STICKY
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Post-ICU Patients Fully Enterally Fed
-
Zealand University HospitalNot yet recruitingPost-Intensive Care Syndrome (PICS) | Intensive Care Unit (ICU) Patients | Symptom Burden
-
National Taiwan University HospitalCompletedPatients Admitted to the ICU More Than 3 Days Post-onsetTaiwan
-
Assistance Publique - Hôpitaux de ParisCompletedPTSD in Family Members of ICU Patients
-
University of MinhoUniversidade do Porto; Virtuleap; Centro Hospitalar De São João, E.P.E.; INESC... and other collaboratorsRecruitingCritical Illness | Cognitive Impairment | Rehabilitation Exercise of ICU Patients | Rehabilitation After Critical Illness | Post-Intensive Care Syndrome (PICS) | Critical Illness Recovery | Intensive Care Unit (ICU)Portugal
Clinical Trials on caloric intake measurement
-
University of ChicagoWithdrawn
-
University of ChicagoNorthwestern University; National Institute on Aging (NIA)Active, not recruitingCardiovascular Diseases | Type2 Diabetes MellitusUnited States
-
Temple UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Active, not recruiting
-
University of MichiganNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)TerminatedWeight Gain | Glomerular Disease | Kidney Transplant; Complications | Kidney TransplantUnited States
-
Arizona State UniversityRecruitingDehydration | Dehydration (Physiology) | Cardiovascular | Glucose AbnormalitiesUnited States
-
University Hospital TuebingenCompletedType 2 Diabetes Mellitus | Liver Fat | Insulin Sensitivity | Nutritional and Metabolic DiseasesGermany
-
Boston Children's HospitalInnovisionCompletedCongenital Heart Defect | Neonatal Respiratory FailureUnited States
-
Centre Hospitalier Universitaire de BesanconFrench Society of RheumatologyRecruitingArthritis, Psoriatic | Spondyloarthritis, AxialFrance
-
Baylor Research InstituteCompletedSepsis | Critical Illness | Nutrition Disorders | Respiratory Failure | Diaphragm Injury | Quadriceps Muscle Atrophy | Calorie DeficiencyUnited States
-
Second Affiliated Hospital of Nanchang UniversityRecruitingType 2 Diabetes Mellitus (T2DM) | Semaglutide | Caloric RestrictionChina