Clinical trial NCT04014816: Gastrointestinal Dysfunction During Enteral Nutrition in Critically Ill Patients
Official title: The Frequency, Risk Factors, and Complications of Gastrointestinal Dysfunction During Enteral Nutrition in Critically Ill Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastrointestinal Disease
Constipation
Intolerance; Nutritional
Diarrhea
Keywords: ICU
Lead sponsor: Ayancık State Hospital
Sponsor class: OTHER_GOV
First posted: 2019-07-10
Enrollment: 137
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The incidence of GI dysfunction
timeFrame: up to 14 days.
Secondary outcomes:
measure: The sequential organ failure assessment(SOFA) score
timeFrame: at admission.
measure: Hypoalbuminemia
timeFrame: up to 14 days.
measure: Catecholamine use
timeFrame: up to 14 days.
measure: Length of hospital stay
timeFrame: through study completion, which is 6 months time period.
Other outcomes:
Locations:
Study officials:
affiliation: Koc University Hospital, Istanbul
name: Evren Senturk, Assoc. Prof
role: STUDY_DIRECTOR
References:
citation: 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.