Gastrointestinal Dysfunction During Enteral Nutrition in Critically Ill Patients

NCT ID: NCT04014816

Last Updated: 2019-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

137 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-01

Study Completion Date

2015-07-01

Brief Summary

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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

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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.

Conditions

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Gastrointestinal Disease Constipation Intolerance; Nutritional Diarrhea

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group I

Patients who had GI dysfunction (Group I) for one or more occasions.

MDR bacteria positivity

Intervention Type OTHER

A total of 137 patients who received nasogastric tube feeding in an ICU of a tertiary hospital were enrolled.

negative fluid balance

Intervention Type OTHER

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.

MDR bacteria positivity

Intervention Type OTHER

A total of 137 patients who received nasogastric tube feeding in an ICU of a tertiary hospital were enrolled.

negative fluid balance

Intervention Type OTHER

A total of 137 patients who received nasogastric tube feeding in an ICU of a tertiary hospital were enrolled.

Interventions

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MDR bacteria positivity

A total of 137 patients who received nasogastric tube feeding in an ICU of a tertiary hospital were enrolled.

Intervention Type OTHER

negative fluid balance

A total of 137 patients who received nasogastric tube feeding in an ICU of a tertiary hospital were enrolled.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ayancık State Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Ayse Gulsah Atasever

Anesthesiology Specialist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Evren Senturk, Assoc. Prof

Role: STUDY_DIRECTOR

Koc University Hospital, Istanbul

References

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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.

Reference Type BACKGROUND
PMID: 29503558 (View on PubMed)

Related Links

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https://www.ncbi.nlm.nih.gov/pubmed/11588461

Upper digestive intolerance during enteral nutrition in critically ill patients: frequency, risk factors, and complications. Crit Care Med. 2001;29:1955-1961.

https://www.ncbi.nlm.nih.gov/pubmed/23883438

Diarrhoea in the ICU: respective contribution of feeding and antibiotics. Crit Care. 2013;17:R153.

https://www.ncbi.nlm.nih.gov/pubmed/10470748

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

Other Identifiers

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2014/1870

Identifier Type: -

Identifier Source: org_study_id

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