Enteral NutritionDC-SCENICNCT05627167
Daytime Cyclic Enteral Nutrition Versus Standard Continuous Enteral Nutrition in the Intensive Care Unit: a Pilot Randomized Controlled Trial
A study testing day time cyclic nutrition and continuous nutrition in people with Enteral Nutrition, run by Centre Hospitalier le Mans at 3 sites in France.
Trial summary
Critical care patients experience systemic aggression, which may be the result of trauma, infection or other systemic inflammatory mechanisms. The initial phase of their illness is characterized by metabolic instability and increased catabolism. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Enteral Nutrition
- What is being tested?
- day time cyclic nutrition and continuous nutrition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 318 participants
- Where
- 3 sitesFrance
- Study dates
- 1 Jun 2023to 17 Feb 2025
- Phase
- Interventional
- 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
Who may be able to join
- Patient aged 18 years and over admitted to intensive care
- On invasive mechanical ventilation for less than 24 hours
- With an indication for exclusive enteral feeding by naso- or oro-gastric tube
- With an expected remaining duration of mechanical ventilation > 72 hours
Who cannot join
- Enteral feeding via tube already started
- Parenteral nutrition in progress or deemed necessary by the practitioner
- Active digestive haemorrhage as evidenced by fibroscopy or with need for transfusion
- Digestive surgery less than one month old
- History of mesenteric ischaemia
- History of gastrectomy, oesophagectomy, duodenopancreatectomy, bariatric surgery, short bowel syndrome
Show all 12Show fewer
- Pregnant, lactating or parturient woman
- Body mass index < 18 kg/m2
- Person deprived of liberty by judicial or administrative decision, person under forced psychiatric care, person under legal protection (guardianship or curatorship)
- Lack of social security coverage
- Lack of consent or emergency procedure form
- Patient participating in another randomised clinical research study on feeding of resuscitation patients
Trial locations and contacts
3 sites in 1 country.
France3 sites
CHU Angers
Angers, 49000
Centre Hospitalier Du Mans
Le Mans, 72000
CHRU Tours
Tours, 37000
About this study
Critical care patients experience systemic aggression, which may be the result of trauma, infection or other systemic inflammatory mechanisms. The initial phase of their illness is characterized by metabolic instability and increased catabolism. Nutrition goals in these patients are therefore, on the one hand, to provide sufficient caloric intake to cover energy expenditure while limiting the risks of inappropriate under-feeding, overfeeding- or re-feeding syndrome, and on the other hand, to meet the protein requirements linked to hypercatabolism. In the absence of contraindication, current recommandations state that an intensive care patient who cannot be fed orally, shoul receive continuous enteral nutrition over 24 hours by gastric tube within 48 hours of admission.
However, this 24-hour continuous nutrition method does not correspond to the physiological habit of the human species which includes a physiological nighttime fasting period.This fasting period induces a metabolic switch that regulates several pathways, including glycemic control, oxidative stressresistance and deoxyribonucleic acid (DNA) repair. Furthermore, it takes part un the synchronization of cellular circadian rhythms.
Investigator hypothetises that diurnal cyclic enteral nutrition may improve the prognosis of severe intensive care patients compared to continuous enteral nutrition.
- Conditions
- Enteral Nutrition
- Being tested
- day time cyclic nutrition, continuous nutrition
- Keywords
- Intensive Care, Enteral nutrition, Organ Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
day time cyclic nutritionOther
Continuous isocaloric enteral feeding (1kcal/ml) with 4g of protein per 100 mL for 10 hours during the day (e.g. 08:00 to 18:00), via nasal or oro-gastric tube
continuous nutritionOther
Isocaloric enteral feeding (1kcal/ml) with 4g of protein per 100ml, continuously 24 hours a day by nasal or oro-gastric tube
| Study group | Role | What they receive |
|---|---|---|
| Daytime Cyclic enteral nutrition | Experimental | Patients receive continuous isocaloric enteral feeding for 10 hours during the day (e.g. 08:00 to 18:00) via nasal or oro-gastric tube Receives: Other: day time cyclic nutrition |
| Continuous enteral nutrition | Active comparator | Patients receive isocaloric enteral feeding continuously 24 hours a day via nasal or oro-gastric tube Receives: Other: continuous nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of organ failures
Change is measured by evolution of the Sequential Organ Failure Assessment (SOFA) score at D7 compared with D0 in both groups
Measured: Day 7
Secondary outcomes (17)
Average daily caloric intake
Average daily caloric intake from enteral nutrition
Measured: Day 1 to Day 7
Proportion of patients achieving > 80% of their recommended caloric intake at D7
Measured: Day 7
Average daily protein intake
Average daily protein intake in grams
Measured: Day 1 to Day 7
Vomiting
Number of days with vomiting (passage of nutrition into the mouth or the endoctracheal tube)
Measured: Day 1 to Day 10
Diarrhea
Number of days with more than four episodes of liquid stools
Measured: Day 1 to Day 10
Constipation
Number of stool free days
Measured: Day 1 to Day 10
Intestinal ischemia
Number of patients suffering an episode of intestinal ischemia
Measured: Day 1 to Day 10
Ventilator acquired pneumonia
Number of episodes of ventilator acquired pneumonias
Measured: Day 1 to Day 10
Insulin consumption
Average insulin consumption expressed in international units per kg per day
Measured: Day 1 to Day 7
Lactatemia
Mean lactatemia measured before the start of a new feeding cycle
Measured: Day 1 to Day 7
Hypoglycemia
Number of days with at least one capillary blood glucose < 0.6 g/L
Measured: Day 1 to Day 7
Ketonemia
Average capillary ketonemia measured in the morning before the start of a new feeding cycle
Measured: Day 1 to Day 7
Bilirubin
Average total plasma bilirubin levels measured in the morning before the start of a new feeding cycle
Measured: Day 1 to Day 7
Urea
Average plasma urea levels measured in the morning before the start of a new feeding cycle
Measured: Day 1 to Day 7
Mortality
Whether patient is alive or dead
Measured: At Day 28
Days without mechanical ventilation
Number of days without mechanical ventilation at D28
Measured: Day 1 to Day 28
Days intubated
Number of days during the ICU stay where the patient received invasive mechanical ventilation
Measured: Day 1 to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2022
- Study start1 Jun 2023
- Primary completion17 Feb 2025
- Study completion17 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Enteral NutritionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 318 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier le Mans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05627167
- Sponsor's protocol ID
- CHM-2022/S03/04
- Acronym
- DC-SCENIC
- Status last verified
- Mar 2025
- First submitted
- 16 Nov 2022
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared upon reasonnable request from the principal investigator.
Publications
Callahan JC, Parot-Schinkel E, Asfar P, Ehrmann S, Tirot P, Guitton C. Impact of daily cyclic enteral nutrition versus standard continuous enteral nutrition in critically ill patients: a study protocol for a randomised controlled trial in three intensive care units in France (DC-SCENIC). BMJ Open. 2024 Jan 29;14(1):e080003. doi: 10.1136/bmjopen-2023-080003.
PubMed 38286683Luetz A, Spies C, Kervezee L. It's about time: circadian medicine in the intensive care unit. Intensive Care Med. 2024 Feb;50(2):283-286. doi: 10.1007/s00134-023-07297-0. Epub 2023 Dec 19. No abstract available.
PubMed 38112772
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Daytime Cyclic Enteral Nutrition Versus Standard Continuous Enteral Nutrition in the Intensive Care Unit: a Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05627167
- Acronym / sponsor ID
- DC-SCENIC / CHM-2022/S03/04
- Conditions
- Enteral Nutrition
- Keywords
- Intensive Care, Enteral nutrition, Organ Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 318 participants (actual)
- Lead sponsor
- Centre Hospitalier le MansUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 17 Feb 2025 (actual)
- Study completion
- 17 Feb 2025 (actual)
- First posted
- 25 Nov 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.
Critical care patients experience systemic aggression, which may be the result of trauma, infection or other systemic inflammatory mechanisms. The initial phase of their illness is characterized by metabolic instability and increased catabolism. Nutrition goals in these patients are therefore, on the one hand, to provide sufficient caloric intake to cover energy expenditure while limiting the risks of inappropriate under-feeding, overfeeding- or re-feeding syndrome, and on the other hand, to meet the protein requirements linked to hypercatabolism. In the absence of contraindication, current recommandations state that an intensive care patient who cannot be fed orally, shoul receive continuous enteral nutrition over 24 hours by gastric tube within 48 hours of admission.
However, this 24-hour continuous nutrition method does not correspond to the physiological habit of the human species which includes a physiological nighttime fasting period.This fasting period induces a metabolic switch that regulates several pathways, including glycemic control, oxidative stressresistance and deoxyribonucleic acid (DNA) repair. Furthermore, it takes part un the synchronization of cellular circadian rhythms.
Investigator hypothetises that diurnal cyclic enteral nutrition may improve the prognosis of severe intensive care patients compared to continuous enteral nutrition.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Daytime Cyclic enteral nutrition | Experimental | Other: day time cyclic nutritionPatients receive continuous isocaloric enteral feeding for 10 hours during the day (e.g. 08:00 to 18:00) via nasal or oro-gastric tube |
| Continuous enteral nutrition | Active comparator | Other: continuous nutritionPatients receive isocaloric enteral feeding continuously 24 hours a day via nasal or oro-gastric tube |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient aged 18 years and over admitted to intensive care
- On invasive mechanical ventilation for less than 24 hours
- With an indication for exclusive enteral feeding by naso- or oro-gastric tube
- With an expected remaining duration of mechanical ventilation > 72 hours
Key exclusion criteria (12 listed)
- Enteral feeding via tube already started
- Parenteral nutrition in progress or deemed necessary by the practitioner
- Active digestive haemorrhage as evidenced by fibroscopy or with need for transfusion
- Digestive surgery less than one month old
- History of mesenteric ischaemia
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 |
|---|---|---|
| day time cyclic nutritionContinuous isocaloric enteral feeding (1kcal/ml) with 4g of protein per 100 mL for 10 hours during the day (e.g. 08:00 to 18:00), via nasal or oro-gastric tube | Other | Daytime Cyclic enteral nutrition |
| continuous nutritionIsocaloric enteral feeding (1kcal/ml) with 4g of protein per 100ml, continuously 24 hours a day by nasal or oro-gastric tube | Other | Continuous enteral nutrition |
Primary outcome
Change of organ failures
Time frame: Day 7
Change is measured by evolution of the Sequential Organ Failure Assessment (SOFA) score at D7 compared with D0 in both groups
17 secondary outcomes
Average daily caloric intake
Time frame: Day 1 to Day 7
Proportion of patients achieving > 80% of their recommended caloric intake at D7
Time frame: Day 7
Average daily protein intake
Time frame: Day 1 to Day 7
Vomiting
Time frame: Day 1 to Day 10
Diarrhea
Time frame: Day 1 to Day 10
Constipation
Time frame: Day 1 to Day 10
Intestinal ischemia
Time frame: Day 1 to Day 10
Ventilator acquired pneumonia
Time frame: Day 1 to Day 10
Insulin consumption
Time frame: Day 1 to Day 7
Lactatemia
Time frame: Day 1 to Day 7
Hypoglycemia
Time frame: Day 1 to Day 7
Ketonemia
Time frame: Day 1 to Day 7
Bilirubin
Time frame: Day 1 to Day 7
Urea
Time frame: Day 1 to Day 7
Mortality
Time frame: At Day 28
Days without mechanical ventilation
Time frame: Day 1 to Day 28
Days intubated
Time frame: Day 1 to Day 28
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 24 Mar 2025.
- Derived from this study: PubMed 38286683Callahan JC, Parot-Schinkel E, Asfar P, Ehrmann S, Tirot P, Guitton C. Impact of daily cyclic enteral nutrition versus standard continuous enteral nutrition in critically ill patients: a study protocol for a randomised controlled trial in three intensive care units in France (DC-SCENIC). BMJ Open. 2024 Jan 29;14(1):e080003. doi: 10.1136/bmjopen-2023-080003.
- Derived from this study: PubMed 38112772Luetz A, Spies C, Kervezee L. It's about time: circadian medicine in the intensive care unit. Intensive Care Med. 2024 Feb;50(2):283-286. doi: 10.1007/s00134-023-07297-0. Epub 2023 Dec 19. No abstract available.
- Individual participant dataSharing planned: Yes. Data will be shared upon reasonnable request from the principal investigator.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing day time cyclic nutrition and continuous nutrition in people with Enteral Nutrition, run by Centre Hospitalier le Mans at 3 sites in France.
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 4 inclusion and 12 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 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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?
Change of organ failures (time frame: Day 7). 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 NCT05627167, which also lists 2 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 24 Mar 2025.