Nutrition DisordersCOINNNCT03573453
Comparison of Continuous Versus Intermittent Enteral Nutrition in Critically Ill Patients.
A study testing enteral nutrition in people with Nutrition Disorders, run by Masaryk University at 1 site in Czechia.
Trial summary
The purpose of the study is to compare continuous versus intermittent strategy for enteral nutrition. The study will examine if there is a difference in achieving nutritional delivery goals, tolerance and number of complications of enteral nutrition. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Nutrition Disorders
- What is being tested?
- enteral nutrition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteCzechia
- Study dates
- 25 Nov 2018to 14 Jun 2023
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age between 18 - 80 years
- indication of enteral nutrition with nasogastric or orogastric tube
- Nutrition Risk in the Critically Ill (NUTRIC) score ≥5
- Body mass index between 18 - 50
- mechanical ventilation expected for at least 72 hours
Who cannot join
- upper gastrointestinal tract surgery in previous medical history
- bowel obstruction
- bowel ischemia
- acute pancreatitis
- severe diarrhoea (>1l/24hours)
- gastrointestinal bleeding
Show all 9Show fewer
- short bowel syndrome
- malabsorption syndrome in previous medical history
- ongoing enteral nutrition on admission to ICU
Trial locations and contacts
1 site in 1 country.
Czechia1 site
University Hospital Brno and Masaryk University Brno
Brno, 62500
About this study
Official title: Comparison of Continuous Versus Intermittent Enteral Nutrition in Critically Ill Patients. Effect on Energy and Protein Target Achievement, Tolerance and Incidence of Complications. Monocentric Prospective Randomised Study.
The purpose of the study is to compare continuous versus intermittent strategy for enteral nutrition. The study will examine if there is a difference in achieving nutritional delivery goals, tolerance and number of complications of enteral nutrition.
Read the detailed description
The study will commence following the Approval by The Ethics Research Committee. All patients admitted to our ICU from the 1st of June 2018 to the 31st of May 2019 will be enrolled after fulfilling the inclusion criteria and in the absence of any exclusion criteria. Informed consent will be requested. Enteral nutrition will be administered via nasogastric of orogastric tube. Patients will be randomised in 2 groups. In the group of patients receiving continuous feeding will be enteral nutrition administered via enteral feeding pump for at least 16 hours par day. In the group of patients receiving intermittent feeding will be enteral nutrition administered as 30-60minutes lasting bolus via enteral feeding pump 6 times per day. Following the administration of the bolus the patient will be placed for 30 minutes in semi-upright sitting position. Enteral nutrition requirement and composition will be standardised with the adoption of international guidelines. In 5 subsequent days from the enteral nutrition commencement will be examined if there is a difference in achieving energy and protein targets, tolerance and number of complications of enteral nutrition in between both groups. As achievement of energy and protein targets will be considered at least 80% of calculated values. The tolerance of enteral nutrition will be evaluated by the clinical examination of the abdomen, presence of diarrhoea, vomiting and the gastric residual volume of at least 0,5 liter. As the complications of enteral nutrition will be regarded the aspiration of gastric contents and ventilator associated pneumonia. Nutritional status parameters will be analysed. the length of hospital stay, ICU length of stay and 28-day mortality will be also monitored.
- Conditions
- Nutrition Disorders
- Being tested
- enteral nutrition
- Keywords
- Critical Care, Enteral Nutrition, Ventilator Associated Pneumonia, Gastric Residual Volume
- Medical subject headings
- Nutrition Disorders, Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enteral nutritionOther
administration of enteral nutrition
| Study group | Role | What they receive |
|---|---|---|
| Intermittent | Experimental | enteral nutrition will be administered via enteral feeding pump as 30-60minutes lasting bolus 6 times per day volume of initial bolus will be 80ml. The volume of bolus will be increased gradually according to tolerance, till the estimated target rate will be reached Receives: Other: enteral nutrition |
| Continuous | Experimental | enteral nutrition will be administered via enteral feeding pump for at least 16 hours par day initial rate will be 25ml/hour. The rate will be increased gradually according to tolerance, till the estimated target rate will be reached Receives: Other: enteral nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy target
Daily assessment of energy intake in critically ill patients with enteral nutrition.Energy target will be achieved if at least 80% of calculated energy intake will be delivered.
Measured: 5 days from initiation of enteral nutrition
Secondary outcomes (8)
Protein target
Daily assessment of protein intake in critically ill patients with enteral nutrition.Protein target will be achieved if at least 80% of calculated protein intake will be delivered.
Measured: 5 days from initiation of enteral nutrition
Tolerance of enteral nutrition
Measurement of the gastric residual volume
Measured: 5 days from initiation of enteral nutrition
Tolerance of enteral nutrition
Incidence of diarrhoea
Measured: 5 days from initiation of enteral nutrition
Tolerance of enteral nutrition
Incidence of vomiting
Measured: 5 days from initiation of enteral nutrition
Complications of enteral nutrition
Incidence of aspiration and ventilator associated pneumonia
Measured: 5 days from initiation of enteral nutrition
Nutritional status
Blood test : total serum protein test
Measured: On admission and day 5 from initiation of enteral nutrition
Nutritional status
Blood test : albumin test
Measured: On admission and day 5 from initiation of enteral nutrition
Nutritional status
Blood test : prealbumin test
Measured: On admission and day 5 from initiation of enteral nutrition
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2018
- Study start25 Nov 2018
- Primary completion17 Dec 2022
- Study completion14 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nutrition DisordersStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masaryk University
- Sponsor type
- University, hospital or other
- Collaborators
- Brno University Hospital
- Responsible party
- Sponsor
- Investigators
- Roman Gal, prof MD PhD, Study chair, Masaryk University Brno
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03573453
- Sponsor's protocol ID
- CT0012018
- Acronym
- COINN
- Status last verified
- Jun 2025
- First submitted
- 17 Apr 2018
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hrdy O, Vrbica K, Strazevska E, Suk P, Souckova L, Stepanova R, Sas I, Gal R. Comparison of continuous versus intermittent enteral nutrition in critically ill patients (COINN): study protocol for a randomized comparative effectiveness trial. Trials. 2020 Nov 23;21(1):955. doi: 10.1186/s13063-020-04866-2.
PubMed 33228772
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Continuous Versus Intermittent Enteral Nutrition in Critically Ill Patients. Effect on Energy and Protein Target Achievement, Tolerance and Incidence of Complications. Monocentric Prospective Randomised Study.
- ClinicalTrials.gov ID
- NCT03573453
- Acronym / sponsor ID
- COINN / CT0012018
- Conditions
- Nutrition Disorders
- Keywords
- Critical Care, Enteral Nutrition, Ventilator Associated Pneumonia, Gastric Residual Volume
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Masaryk UniversityUniversity, hospital or other
- Collaborators
- Brno University Hospital
- Study start
- 25 Nov 2018 (actual)
- Primary completion
- 17 Dec 2022 (actual)
- Study completion
- 14 Jun 2023 (actual)
- First posted
- 29 Jun 2018 (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.
The purpose of the study is to compare continuous versus intermittent strategy for enteral nutrition. The study will examine if there is a difference in achieving nutritional delivery goals, tolerance and number of complications of enteral nutrition.
Detailed description
The study will commence following the Approval by The Ethics Research Committee. All patients admitted to our ICU from the 1st of June 2018 to the 31st of May 2019 will be enrolled after fulfilling the inclusion criteria and in the absence of any exclusion criteria. Informed consent will be requested. Enteral nutrition will be administered via nasogastric of orogastric tube. Patients will be randomised in 2 groups. In the group of patients receiving continuous feeding will be enteral nutrition administered via enteral feeding pump for at least 16 hours par day. In the group of patients receiving intermittent feeding will be enteral nutrition administered as 30-60minutes lasting bolus via enteral feeding pump 6 times per day. Following the administration of the bolus the patient will be placed for 30 minutes in semi-upright sitting position. Enteral nutrition requirement and composition will be standardised with the adoption of international guidelines. In 5 subsequent days from the enteral nutrition commencement will be examined if there is a difference in achieving energy and protein targets, tolerance and number of complications of enteral nutrition in between both groups. As achievement of energy and protein targets will be considered at least 80% of calculated values. The tolerance of enteral nutrition will be evaluated by the clinical examination of the abdomen, presence of diarrhoea, vomiting and the gastric residual volume of at least 0,5 liter. As the complications of enteral nutrition will be regarded the aspiration of gastric contents and ventilator associated pneumonia. Nutritional status parameters will be analysed. the length of hospital stay, ICU length of stay and 28-day mortality will be also monitored.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intermittent | Experimental | Other: enteral nutritionenteral nutrition will be administered via enteral feeding pump as 30-60minutes lasting bolus 6 times per day volume of initial bolus will be 80ml. The volume of bolus will be increased gradually according to tolerance, till the estimated target rate will be reached |
| Continuous | Experimental | Other: enteral nutritionenteral nutrition will be administered via enteral feeding pump for at least 16 hours par day initial rate will be 25ml/hour. The rate will be increased gradually according to tolerance, till the estimated target rate will be reached |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age between 18 - 80 years
- indication of enteral nutrition with nasogastric or orogastric tube
- Nutrition Risk in the Critically Ill (NUTRIC) score ≥5
- Body mass index between 18 - 50
- mechanical ventilation expected for at least 72 hours
Key exclusion criteria (9 listed)
- upper gastrointestinal tract surgery in previous medical history
- bowel obstruction
- bowel ischemia
- acute pancreatitis
- severe diarrhoea (>1l/24hours)
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 |
|---|---|---|
| enteral nutritionadministration of enteral nutrition | Other | Continuous, Intermittent |
Primary outcome
Energy target
Time frame: 5 days from initiation of enteral nutrition
Daily assessment of energy intake in critically ill patients with enteral nutrition.Energy target will be achieved if at least 80% of calculated energy intake will be delivered.
8 secondary outcomes
Protein target
Time frame: 5 days from initiation of enteral nutrition
Tolerance of enteral nutrition
Time frame: 5 days from initiation of enteral nutrition
Tolerance of enteral nutrition
Time frame: 5 days from initiation of enteral nutrition
Tolerance of enteral nutrition
Time frame: 5 days from initiation of enteral nutrition
Complications of enteral nutrition
Time frame: 5 days from initiation of enteral nutrition
Nutritional status
Time frame: On admission and day 5 from initiation of enteral nutrition
Nutritional status
Time frame: On admission and day 5 from initiation of enteral nutrition
Nutritional status
Time frame: On admission and day 5 from initiation of enteral nutrition
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 16 Oct 2026.
- Derived from this study: PubMed 33228772Hrdy O, Vrbica K, Strazevska E, Suk P, Souckova L, Stepanova R, Sas I, Gal R. Comparison of continuous versus intermittent enteral nutrition in critically ill patients (COINN): study protocol for a randomized comparative effectiveness trial. Trials. 2020 Nov 23;21(1):955. doi: 10.1186/s13063-020-04866-2.
- Individual participant dataSharing planned: No
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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.
Roman Gal, prof MD PhD study chair
Masaryk University Brno
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing enteral nutrition in people with Nutrition Disorders, run by Masaryk University at 1 site in Czechia.
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 5 inclusion and 9 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 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. 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?
Energy target (time frame: 5 days from initiation of enteral nutrition). 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 NCT03573453, which also lists 1 linked publication.
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 16 Oct 2026.