Critically IllPhase 4NCT02282501
Leptin and Ghrelin in ICU
A Phase 4 study testing enteral feeding by nasogastric tube. in people with Critically Ill, run by özgür yağan at 1 site in Turkey (Türkiye).
Trial summary
Enteral alimentation is the preferred modality of support in critical patients who have acceptable digestive function and are unable to eat orally, but the advantages of continuous versus intermittent administration are surrounded by controversy. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Critically Ill
- What is being tested?
- enteral feeding by nasogastric tube.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Aug 2014to Feb 2016
- Phase
- Phase 4
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- who were unable to ingest an oral diet
- given decision on enteral feeding
Who cannot join
- Carcinomatosis
- irreversible coma
- death or discharge before 14 days of observation
- contraindication to enteral feeding
- intolerance to the prescribed nutrients or infusion regimen
- burn
Show all 14Show fewer
- multiple trauma
- morbid obesity
- end stage liver or renal or lung disease
- severe sepsis or septic shock
- patients with percutaneous endoscopic gastrostomy
- immunosuppressive drug use
- severe hemodynamic instability
- massive blood transfusion
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Anesthesiology and Reanimation Dept. Ordu University Training and Research Hospital
Altinordu, Ordu, 52100
About this study
Enteral alimentation is the preferred modality of support in critical patients who have acceptable digestive function and are unable to eat orally, but the advantages of continuous versus intermittent administration are surrounded by controversy.
This prospective, randomised study was designed to compare two enteral feeding methods with respect to changes in levels of leptin and ghrelin in ICU.
- Conditions
- Critically Ill
- Being tested
- enteral feeding by nasogastric tube.
- Keywords
- leptin levels, ghrelin levels
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enteral feeding by nasogastric tube.Other
method of administration enteral feeding by nasogastric tube.
| Study group | Role | What they receive |
|---|---|---|
| intermittent feeding | Active comparator | Bolus infusion - The total daily feeding period was also 4-6 times a day. Receives: Other: enteral feeding by nasogastric tube. |
| continuous feeding | Active comparator | Continuous infusion - The daily desired amount was offered continuously for 20 hours a day. Receives: Other: enteral feeding by nasogastric tube. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in serum leptin concentration at three weeks in ICU
Measured: first, 7th, 14th and 21th day
Change from baseline in serum ghrelin concentration at three weeks in ICU
Measured: first, 7th, 14th and 21th day in ICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2014 (estimated)
- Study startAug 2014
- Primary completionOct 2015
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critically IllStudies 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 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- özgür yağan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, özgür yağan, Ordu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02282501
- Sponsor's protocol ID
- Odu-4
- Status last verified
- Mar 2016
- First submitted
- 30 Oct 2014
- Last updated
- 29 Mar 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leptin and Ghrelin in ICU
- ClinicalTrials.gov ID
- NCT02282501
- Acronym / sponsor ID
- Odu-4
- Conditions
- Critically Ill
- Keywords
- leptin levels, ghrelin levels
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- özgür yağanUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 4 Nov 2014 (estimated)
- 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.
Enteral alimentation is the preferred modality of support in critical patients who have acceptable digestive function and are unable to eat orally, but the advantages of continuous versus intermittent administration are surrounded by controversy.
This prospective, randomised study was designed to compare two enteral feeding methods with respect to changes in levels of leptin and ghrelin in ICU.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intermittent feeding | Active comparator | Other: enteral feeding by nasogastric tube.Bolus infusion - The total daily feeding period was also 4-6 times a day. |
| continuous feeding | Active comparator | Other: enteral feeding by nasogastric tube.Continuous infusion - The daily desired amount was offered continuously for 20 hours a day. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- who were unable to ingest an oral diet
- given decision on enteral feeding
Key exclusion criteria (14 listed)
- Carcinomatosis
- irreversible coma
- death or discharge before 14 days of observation
- contraindication to enteral feeding
- intolerance to the prescribed nutrients or infusion regimen
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 feeding by nasogastric tube.method of administration enteral feeding by nasogastric tube. | Other | continuous feeding, intermittent feeding |
Primary outcome
Change from baseline in serum leptin concentration at three weeks in ICU
Time frame: first, 7th, 14th and 21th day
Change from baseline in serum ghrelin concentration at three weeks in ICU
Time frame: first, 7th, 14th and 21th day in ICU
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 29 Mar 2016.
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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 Phase 4 study testing enteral feeding by nasogastric tube. in people with Critically Ill, run by özgür yağan 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 2 inclusion and 14 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 29 Mar 2016. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 from baseline in serum leptin concentration at three weeks in ICU (time frame: first, 7th, 14th and 21th day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Mar 2016.