- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04014816
Gastrointestinal Dysfunction During Enteral Nutrition in Critically Ill Patients
July 9, 2019 updated by: Ayse Gulsah Atasever, Ayancık State Hospital
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.
Study Overview
Status
Completed
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
137
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
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.
Description
Inclusion Criteria:
Older than 18 years old. Stay longer than 48 hours at ICU.
Exclusion Criteria:
Has enterostomy/colostomy or diagnosis of GI bleeding. Prone position. Laxative drug use. Clostridium Difficile infection positivity.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Group I
Patients who had GI dysfunction (Group I) for one or more occasions.
|
A total of 137 patients who received nasogastric tube feeding in an ICU of a tertiary hospital were enrolled.
A total of 137 patients who received nasogastric tube feeding in an ICU of a tertiary hospital were enrolled.
|
Group II
Patients who had normal GI function (Group II) for one or more occasions.
|
A total of 137 patients who received nasogastric tube feeding in an ICU of a tertiary hospital were enrolled.
A total of 137 patients who received nasogastric tube feeding in an ICU of a tertiary hospital were enrolled.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The incidence of GI dysfunction
Time Frame: up to 14 days.
|
Constipation, diarrhea, UDI
|
up to 14 days.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The sequential organ failure assessment(SOFA) score
Time Frame: at admission.
|
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%.
|
at admission.
|
Hypoalbuminemia
Time Frame: up to 14 days.
|
below 2,5 g/dl
|
up to 14 days.
|
Catecholamine use
Time Frame: up to 14 days.
|
mcg
|
up to 14 days.
|
Length of hospital stay
Time Frame: through study completion, which is 6 months time period.
|
days
|
through study completion, which is 6 months time period.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Evren Senturk, Assoc. Prof, Koc University Hospital, Istanbul
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
- Upper digestive intolerance during enteral nutrition in critically ill patients: frequency, risk factors, and complications. Crit Care Med. 2001;29:1955-1961.
- Diarrhoea in the ICU: respective contribution of feeding and antibiotics. Crit Care. 2013;17:R153.
- 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;27:1447-1
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2015
Primary Completion (Actual)
July 1, 2015
Study Completion (Actual)
July 1, 2015
Study Registration Dates
First Submitted
July 4, 2019
First Submitted That Met QC Criteria
July 9, 2019
First Posted (Actual)
July 10, 2019
Study Record Updates
Last Update Posted (Actual)
July 10, 2019
Last Update Submitted That Met QC Criteria
July 9, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014/1870
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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