Gastrointestinal DiseaseNCT04014816
Gastrointestinal Dysfunction During Enteral Nutrition in Critically Ill Patients
An observational study of Gastrointestinal Disease and Constipation, run by Ayancık State Hospital.
Trial summary
Gastrointestinal (GI) motility disorders in intensive care patients remain relatively unexplored. Nowadays, the frequency, risk factors and complications of GI dysfunction during enteral nutrition (EN) become more questionable. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Disease, Constipation, Intolerance; Nutritional
- What is being tested?
- MDR bacteria positivity and negative fluid balance
- How many people
- 137 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 1 Jul 2015
- Phase
- Observational
- 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
Study population: In this prospective observational study, 137 out of 226 patients consecutively admitted into a mixed medical-surgical ICU from 1 January 2015 to 31 June 2015 were enrolled.
Who may be able to join
- Older than 18 years old. Stay longer than 48 hours at ICU.
Who cannot join
- Has enterostomy/colostomy or diagnosis of GI bleeding. Prone position. Laxative drug use. Clostridium Difficile infection positivity.
About this study
Official title: The Frequency, Risk Factors, and Complications of Gastrointestinal Dysfunction During Enteral Nutrition in Critically Ill Patients
Gastrointestinal (GI) motility disorders in intensive care patients remain relatively unexplored. Nowadays, the frequency, risk factors and complications of GI dysfunction during enteral nutrition (EN) become more questionable. Our aim is to evaluate the frequency, risk factors and complications of GI dysfunction during EN in the first 2 weeks of the intensive care unit (ICU) stay and to identify precautions to prevent the development of GI dysfunction and avoid complications.
Read the detailed description
Critical illness is typically associated with a catabolic stress state in which patients demonstrate a systemic inflammatory response coupled with complications of increased infectious morbidity, multiple organ dysfunction, prolonged hospitalization, and disproportionate mortality. Suspension of feeding and the resultant inability to reach nutritional goals is one complication of gastrointestinal (GI) dysfunction, but there are others (mucosal barrier disruption, altered motility, atrophy of the mucosa, and reduced mass of gut-associated lymphoid tissue) that may explain the greater length of stay (LOS) and death rate with GI dysfunction. In Europe and the United States, nutritional administration guidelines recommend primarily enteral nutrition (EN) for hemodynamically stable intensive care unit (ICU) patients. Providing EN in these patients has been shown to be superior to parenteral nutrition. GI complications such as constipation, delayed gastric emptying, diarrhea, and vomiting may occur in up to 50% of mechanically ventilated patients and adversely affect ICU mortality and LOS. Nevertheless, there is no consensus for obtaining a precise assessment of GI function.Diagnosis of GI dysfunction in ICU patients is complex and relies on clinical symptoms. Lack of validated markers of GI system dysfunction is often misdiagnosed and poorly managed in the ICU. The role of nutrition in critical illness is important, but there is an increasing evidence and broadening consensus that aggressive early feeding as well as prolonged underfeeding both should be avoided. Avoidance of complications like malnutrition, aspiration of gastric contents, wound infections, and decubitus through GI dysfunction is an important part of management of patients with GI failure.
- Being tested
- MDR bacteria positivity, negative fluid balance
- Keywords
- ICU
- Medical subject headings
- Gastrointestinal Diseases, Constipation, Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MDR bacteria positivityOther
A total of 137 patients who received nasogastric tube feeding in an ICU of a tertiary hospital were enrolled.
negative fluid balanceOther
A total of 137 patients who received nasogastric tube feeding in an ICU of a tertiary hospital were enrolled.
| Study group | Role | What they receive |
|---|---|---|
| Group I | Patients who had GI dysfunction (Group I) for one or more occasions. Receives: Other: MDR bacteria positivity; Other: negative fluid balance | |
| Group II | Patients who had normal GI function (Group II) for one or more occasions. Receives: Other: MDR bacteria positivity; Other: negative fluid balance |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of GI dysfunction
Constipation, diarrhea, UDI
Measured: up to 14 days.
Secondary outcomes (4)
The sequential organ failure assessment(SOFA) score
SOFA Score is a mortality pre-score that is based on the degree of dysfunction of six organ systems. Each organ system is assigned a point value from 0 (normal)to 4 (high degree of dysfunction/failure). The SOFA score ranges from 0 to 24.The highest SOFA score correlates with highest mortality rates. Scores of more than 11 corresponded to mortality of more than 80%.
Measured: at admission.
Hypoalbuminemia
below 2,5 g/dl
Measured: up to 14 days.
Catecholamine use
mcg
Measured: up to 14 days.
Length of hospital stay
days
Measured: through study completion, which is 6 months time period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2019
- Study start1 Jan 2015
- Primary completion1 Jul 2015
- Study completion1 Jul 2015
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 Gastrointestinal DiseaseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ayancık State Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ayse Gulsah Atasever, Ayancık State Hospital
- Investigators
- Evren Senturk, Assoc. Prof, Study director, Koc University Hospital, Istanbul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04014816
- Sponsor's protocol ID
- 2014/1870
- Status last verified
- Jul 2019
- First submitted
- 4 Jul 2019
- Last updated
- 10 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Atasever AG, Ozcan PE, Kasali K, Abdullah T, Orhun G, Senturk E. The frequency, risk factors, and complications of gastrointestinal dysfunction during enteral nutrition in critically ill patients. Ther Clin Risk Manag. 2018 Feb 23;14:385-391. doi: 10.2147/TCRM.S158492. eCollection 2018.
PubMed 29503558
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Frequency, Risk Factors, and Complications of Gastrointestinal Dysfunction During Enteral Nutrition in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT04014816
- Acronym / sponsor ID
- 2014/1870
- Keywords
- ICU
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Ayancık State HospitalOther government
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 1 Jul 2015 (actual)
- Study completion
- 1 Jul 2015 (actual)
- First posted
- 10 Jul 2019 (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.
Gastrointestinal (GI) motility disorders in intensive care patients remain relatively unexplored. Nowadays, the frequency, risk factors and complications of GI dysfunction during enteral nutrition (EN) become more questionable. Our aim is to evaluate the frequency, risk factors and complications of GI dysfunction during EN in the first 2 weeks of the intensive care unit (ICU) stay and to identify precautions to prevent the development of GI dysfunction and avoid complications.
Detailed description
Critical illness is typically associated with a catabolic stress state in which patients demonstrate a systemic inflammatory response coupled with complications of increased infectious morbidity, multiple organ dysfunction, prolonged hospitalization, and disproportionate mortality. Suspension of feeding and the resultant inability to reach nutritional goals is one complication of gastrointestinal (GI) dysfunction, but there are others (mucosal barrier disruption, altered motility, atrophy of the mucosa, and reduced mass of gut-associated lymphoid tissue) that may explain the greater length of stay (LOS) and death rate with GI dysfunction. In Europe and the United States, nutritional administration guidelines recommend primarily enteral nutrition (EN) for hemodynamically stable intensive care unit (ICU) patients. Providing EN in these patients has been shown to be superior to parenteral nutrition. GI complications such as constipation, delayed gastric emptying, diarrhea, and vomiting may occur in up to 50% of mechanically ventilated patients and adversely affect ICU mortality and LOS. Nevertheless, there is no consensus for obtaining a precise assessment of GI function.Diagnosis of GI dysfunction in ICU patients is complex and relies on clinical symptoms. Lack of validated markers of GI system dysfunction is often misdiagnosed and poorly managed in the ICU. The role of nutrition in critical illness is important, but there is an increasing evidence and broadening consensus that aggressive early feeding as well as prolonged underfeeding both should be avoided. Avoidance of complications like malnutrition, aspiration of gastric contents, wound infections, and decubitus through GI dysfunction is an important part of management of patients with GI failure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | – | Other: MDR bacteria positivity, Other: negative fluid balancePatients who had GI dysfunction (Group I) for one or more occasions. |
| Group II | – | Other: MDR bacteria positivity, Other: negative fluid balancePatients who had normal GI function (Group II) for one or more occasions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In this prospective observational study, 137 out of 226 patients consecutively admitted into a mixed medical-surgical ICU from 1 January 2015 to 31 June 2015 were enrolled.
Key inclusion criteria (1 listed)
- Older than 18 years old. Stay longer than 48 hours at ICU.
Key exclusion criteria (1 listed)
- Has enterostomy/colostomy or diagnosis of GI bleeding. Prone position. Laxative drug use. Clostridium Difficile infection positivity.
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 |
|---|---|---|
| MDR bacteria positivityA total of 137 patients who received nasogastric tube feeding in an ICU of a tertiary hospital were enrolled. | Other | Group I, Group II |
| negative fluid balanceA total of 137 patients who received nasogastric tube feeding in an ICU of a tertiary hospital were enrolled. | Other | Group I, Group II |
Primary outcome
The incidence of GI dysfunction
Time frame: up to 14 days.
Constipation, diarrhea, UDI
4 secondary outcomes
The sequential organ failure assessment(SOFA) score
Time frame: at admission.
Hypoalbuminemia
Time frame: up to 14 days.
Catecholamine use
Time frame: up to 14 days.
Length of hospital stay
Time frame: through study completion, which is 6 months time period.
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 10 Jul 2019.
- Background: PubMed 29503558Atasever AG, Ozcan PE, Kasali K, Abdullah T, Orhun G, Senturk E. The frequency, risk factors, and complications of gastrointestinal dysfunction during enteral nutrition in critically ill patients. Ther Clin Risk Manag. 2018 Feb 23;14:385-391. doi: 10.2147/TCRM.S158492. eCollection 2018.
- Upper digestive intolerance during enteral nutrition in critically ill patients: frequency, risk factors, and complications. Crit Care Med. 2001;29:1955-1961.Link provided by the sponsor.
- Diarrhoea in the ICU: respective contribution of feeding and antibiotics. Crit Care. 2013;17:R153.Link provided by the sponsor.
- Enteralnutrition-relatedgastrointestinalcomplicationsin critically ill patients: a multicenter study: The Nutritional and Metabolic Working Group of the Spanish Society of Intensive Care Medicine and Coronary Units. Crit Care Med. 1999;27:1447-1Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Evren Senturk, Assoc. Prof study director
Koc University Hospital, Istanbul
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrointestinal Disease and Constipation, run by Ayancık State Hospital.
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 1 inclusion and 1 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 10 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
The incidence of GI dysfunction (time frame: up to 14 days.). 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 NCT04014816, 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 10 Jul 2019.