Enteral Feeding IntoleranceNCT05812664
The Effects of Bolus, Intermittent and Continuous Enteral Feeding on Blood Glucose and Feeding Intolerance in ICU Patients With Sepsis
A study testing enteral feeding, blood glucose measurements and Evaluation of feeding intolerance with gastric residue in people with Enteral Feeding Intolerance, run by Umraniye Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Comparison of the effects of bolus, intermittent and continuous enteral feeding techniques on plasma glucose level and enteral feeding intolerance in adult intensive care unit patients with sepsis. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Enteral Feeding Intolerance
- What is being tested?
- enteral feeding, blood glucose measurements and Evaluation of feeding intolerance with gastric residue
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Dec 2023to Dec 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hospitalized in ICU for more than 3 days
- Ages between 18-70 years
- APACHI II is in the range of 8-25
- BMI in the range of 18.5-30
- Able to receive enteral nutrition from N/G
- Intubated on ventilator support
Show all 12Show fewer
- No previous diagnosis of Diabetes Mellitus,
- Those who have not had Gastro intestinal System surgery in the last 6 months
- Patients not receiving inotropic support
- not receiving hemodiafiltration
- No history of allergy to the food used
- Patients with a focus of infection and/or culture-positive patients diagnosed with sepsis according to Q SOFA (cultures were taken from all patients)
Who cannot join
- patient's death during the study
- Taking more than 40 mg of IV steroids daily
- Increased baseline APACHI II score
- Development of the patient's need for inotropes
- Elimination of inclusion criteria
- negative culture
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Umraniye Education and research hospital
Istanbul, 34111
About this study
Official title: The Comparison of Effects of Bolus, Intermittent (Nocturnal Pause) and Continuous Enteral Feeding Methods on Blood Glucose and Feeding Intolerance in ICU Patients With Sepsis, Prospective, Randomized, Controlled Study
Comparison of the effects of bolus, intermittent and continuous enteral feeding techniques on plasma glucose level and enteral feeding intolerance in adult intensive care unit patients with sepsis.
Read the detailed description
in this prospective, controlled trial the main aim is to evaluate the effects of bolus, intermittent and continuous enteral feeding techniques on plasma glucose level in intensive care patients with sepsis diagnosis and to determine whether they are superior to each other in providing norma-glycemia. The secondary aim is to determine the effect of these 3 different enteral feeding techniques on enteral feeding intolerance.
- Conditions
- Enteral Feeding Intolerance
- Being tested
- enteral feeding, blood glucose measurements, Evaluation of feeding intolerance with gastric residue
- Keywords
- plasma glucose levels,, enteral feeding intolerance, enteral feeding methods, sepsis
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enteral feedingOther
The amount of enteral nutrition that should be given daily was calculated by the nutritionist using the Harris-Benedict formula. Formula at room temperature was given with a nasogastric foley catheter and a feeding pump. The position of the nasogastric Foley catheter in the stomach was confirmed by the PAAC graph when it was first inserted, and by listening before each feeding. Feeding was done in a position with the head at 30 degrees.
blood glucose measurementsProcedure or surgery
Blood glucose values were measured in all groups at 06:00, 12:00, 18:00 and 24:00, 4 times a day for 7 days. The sample was taken from the patient's cannula and examined in the biochemistry lab. The targeted range in the measurements was accepted as 70-180 mg/dl.
Evaluation of feeding intolerance with gastric residueProcedure or surgery
gastric residue assessment; 30 minutes after the feeding was stopped, the N/G tube was drained and the amount coming 30 minutes later was evaluated. Residue positive was defined as the return of more than half of the amount of formula in the last cycle. The same was continued without increasing the amount given. If the incoming amount was less than half, the residue was evaluated as negative and the formula was continued by increasing the predetermined amount.
| Study group | Role | What they receive |
|---|---|---|
| bolus feeding group | Experimental | bolus feeding method;The amount of food to be given for 24 hours calculated for the patient was given as 4 equal amounts for 40 minutes at 4 different times. Starting with 150 cc, the target calorie was reached by increasing 100 cc according to the intolerance before the next feeding hour. Receives: Other: enteral feeding; Procedure: blood glucose measurements; Procedure: Evaluation of feeding intolerance with gastric residue |
| intermittent feeding group | Experimental | The formula was started as 40 cc/h continuous infusion. It was interrupted after 5 hours. 30 minutes after the break, PGD was measured and intolerance was checked, and if the residue was negative, it was increased by 40 cc. The amount was increased until reaching the amount of formula that should be given for 24 hours calculated for the patient. This cycle was repeated 3 times in 24 hours. At 24:00, it was stopped and feeding was interrupted between 24:00 and 06:00. Receives: Other: enteral feeding; Procedure: blood glucose measurements; Procedure: Evaluation of feeding intolerance with gastric residue |
| continous feeding group | Active comparator | The same method was applied as in Group 2. However, after 24:00, feeding was not interrupted and continued as the 4th cycle. Receives: Other: enteral feeding; Procedure: blood glucose measurements; Procedure: Evaluation of feeding intolerance with gastric residue |
What is being measured
The primary outcome is the main question the study is designed to answer.
effect of enteral feeding methods on blood glucose levels
Evaluation of hypo/hyperglycemia development by measuring blood glucose level 4 times a day
Measured: for 7 days after the start of feeding
Secondary outcomes (1)
feeding intolerance
effect on feeding intolerance, detection of more than half of the feeding amount will be taken as gastric residue positive so intolerance positive
Measured: during the 7th day with the start of feeding
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2023
- Study startDec 2023 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
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 Enteral Feeding IntoleranceStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- If the patients were diagnosed with sepsis in ICU, they were not fed after 24:00, and if the gastric residual measured at 05:00 in the morning was negative, they were included in the study. The patients were examined in 3 groups. The number of samples required to be taken in the power analysis performed (G\*power 3.1) was found to be 93 (31 patients in each group) (power value 0.80, alpha error probability=0.05). Patients for the groups were randomly selected by the closed envelope method. A total of 93 envelopes, 31 for each group, were prepared. When the patient was diagnosed with sepsis, if he/she met the inclusion criteria, a random envelope was selected to determine the patient's group. After inclusion in the study, a closed envelope was added again for the patients who should be excluded from the study.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 93 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Umraniye Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Senay Goksu, Umraniye Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05812664
- Sponsor's protocol ID
- ENTERAL FEEDİNG
- Status last verified
- Dec 2023
- First submitted
- 11 Mar 2023
- Last updated
- 13 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: all IPD shared with other researches
Publications
Goksu S, Tuncel Z. Which is better for glycemic control? bolus, intermittent (nocturnal pause) or continuous enteral feeding in septic critically ill patients. Sci Prog. 2025 Oct-Dec;108(4):368504251392606. doi: 10.1177/00368504251392606. Epub 2025 Nov 4.
PubMed 41186504
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of Effects of Bolus, Intermittent (Nocturnal Pause) and Continuous Enteral Feeding Methods on Blood Glucose and Feeding Intolerance in ICU Patients With Sepsis, Prospective, Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT05812664
- Acronym / sponsor ID
- ENTERAL FEEDİNG
- Conditions
- Enteral Feeding Intolerance
- Keywords
- plasma glucose levels,, enteral feeding intolerance, enteral feeding methods, sepsis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 93 participants (estimated)
- Lead sponsor
- Umraniye Education and Research HospitalOther government
- Study start
- Dec 2023 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 14 Apr 2023 (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.
Comparison of the effects of bolus, intermittent and continuous enteral feeding techniques on plasma glucose level and enteral feeding intolerance in adult intensive care unit patients with sepsis.
Detailed description
in this prospective, controlled trial the main aim is to evaluate the effects of bolus, intermittent and continuous enteral feeding techniques on plasma glucose level in intensive care patients with sepsis diagnosis and to determine whether they are superior to each other in providing norma-glycemia. The secondary aim is to determine the effect of these 3 different enteral feeding techniques on enteral feeding intolerance.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- If the patients were diagnosed with sepsis in ICU, they were not fed after 24:00, and if the gastric residual measured at 05:00 in the morning was negative, they were included in the study. The patients were examined in 3 groups. The number of samples required to be taken in the power analysis performed (G*power 3.1) was found to be 93 (31 patients in each group) (power value 0.80, alpha error probability=0.05). Patients for the groups were randomly selected by the closed envelope method. A total of 93 envelopes, 31 for each group, were prepared. When the patient was diagnosed with sepsis, if he/she met the inclusion criteria, a random envelope was selected to determine the patient's group. After inclusion in the study, a closed envelope was added again for the patients who should be excluded from the study.
| Arm | Type | Receives |
|---|---|---|
| bolus feeding group | Experimental | Other: enteral feeding, Procedure: blood glucose measurements, Procedure: Evaluation of feeding intolerance with gastric residuebolus feeding method;The amount of food to be given for 24 hours calculated for the patient was given as 4 equal amounts for 40 minutes at 4 different times. Starting with 150 cc, the target calorie was reached by increasing 100 cc according to the intolerance before the next feeding hour. |
| intermittent feeding group | Experimental | Other: enteral feeding, Procedure: blood glucose measurements, Procedure: Evaluation of feeding intolerance with gastric residueThe formula was started as 40 cc/h continuous infusion. It was interrupted after 5 hours. 30 minutes after the break, PGD was measured and intolerance was checked, and if the residue was negative, it was increased by 40 cc. The amount was increased until reaching the amount of formula that should be given for 24 hours calculated for the patient. This cycle was repeated 3 times in 24 hours. At 24:00, it was stopped and feeding was interrupted between 24:00 and 06:00. |
| continous feeding group | Active comparator | Other: enteral feeding, Procedure: blood glucose measurements, Procedure: Evaluation of feeding intolerance with gastric residueThe same method was applied as in Group 2. However, after 24:00, feeding was not interrupted and continued as the 4th cycle. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Hospitalized in ICU for more than 3 days
- Ages between 18-70 years
- APACHI II is in the range of 8-25
- BMI in the range of 18.5-30
- Able to receive enteral nutrition from N/G
Key exclusion criteria (6 listed)
- patient's death during the study
- Taking more than 40 mg of IV steroids daily
- Increased baseline APACHI II score
- Development of the patient's need for inotropes
- Elimination of inclusion criteria
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 feedingThe amount of enteral nutrition that should be given daily was calculated by the nutritionist using the Harris-Benedict formula. Formula at room temperature was given with a nasogastric foley catheter and a feeding pump. The position of the nasogastric Foley catheter in the stomach was confirmed by the PAAC graph when it was first inserted, and by listening before each feeding. Feeding was done in a position with the head at 30 degrees. | Other | bolus feeding group, continous feeding group, intermittent feeding group |
| blood glucose measurementsBlood glucose values were measured in all groups at 06:00, 12:00, 18:00 and 24:00, 4 times a day for 7 days. The sample was taken from the patient's cannula and examined in the biochemistry lab. The targeted range in the measurements was accepted as 70-180 mg/dl. | Procedure or surgery | bolus feeding group, continous feeding group, intermittent feeding group |
| Evaluation of feeding intolerance with gastric residuegastric residue assessment; 30 minutes after the feeding was stopped, the N/G tube was drained and the amount coming 30 minutes later was evaluated. Residue positive was defined as the return of more than half of the amount of formula in the last cycle. The same was continued without increasing the amount given. If the incoming amount was less than half, the residue was evaluated as negative and the formula was continued by increasing the predetermined amount. | Procedure or surgery | bolus feeding group, continous feeding group, intermittent feeding group |
Primary outcome
effect of enteral feeding methods on blood glucose levels
Time frame: for 7 days after the start of feeding
Evaluation of hypo/hyperglycemia development by measuring blood glucose level 4 times a day
1 secondary outcome
feeding intolerance
Time frame: during the 7th day with the start of feeding
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2023.
- Derived from this study: PubMed 41186504Goksu S, Tuncel Z. Which is better for glycemic control? bolus, intermittent (nocturnal pause) or continuous enteral feeding in septic critically ill patients. Sci Prog. 2025 Oct-Dec;108(4):368504251392606. doi: 10.1177/00368504251392606. Epub 2025 Nov 4.
- Individual participant dataSharing planned: No. all IPD shared with other researches
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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.
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 feeding, blood glucose measurements and Evaluation of feeding intolerance with gastric residue in people with Enteral Feeding Intolerance, run by Umraniye Education and Research Hospital at 1 site in Turkey (Türkiye).
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 12 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 13 Dec 2023. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
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?
effect of enteral feeding methods on blood glucose levels (time frame: for 7 days after the start of feeding). 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 NCT05812664, 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 13 Dec 2023.