Gastrointestinal Dysfunction During Enteral Nutrition in Critically Ill Patients

Completed

• Conditions: Constipation; Diarrhea; Gastrointestinal Disease; Intolerance; Nutritional
• Interventions: Other: MDR bacteria positivity; Other: negative fluid balance

• Registration Number: NCT04014816
• Lead Sponsor: Ayancık State Hospital

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.

Study Timeline

• Study Start: 2015-01-01
• Primary Completion: 2015-07-01
• Study Completion: 2015-07-01
• Status Verified: 2019-07
• Study First Submitted: 2019-07-04
• Study First Submitted QC: 2019-07-09
• Last Update Submitted: 2019-07-09
• Study First Posted: 2019-07-10
• Last Update Posted: 2019-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 137

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group I	MDR bacteria positivity	Patients who had GI dysfunction (Group I) for one or more occasions.
Group II	MDR bacteria positivity	Patients who had normal GI function (Group II) for one or more occasions.
Group II	negative fluid balance	Patients who had normal GI function (Group II) for one or more occasions.
Group I	negative fluid balance	Patients who had GI dysfunction (Group I) for one or more occasions.

Primary Outcome Measures

Name	Time	Method
The incidence of GI dysfunction	up to 14 days.	Constipation, diarrhea, UDI

Secondary Outcome Measures

Name	Time	Method
Length of hospital stay	through study completion, which is 6 months time period.	days
Catecholamine use	up to 14 days.	mcg
The sequential organ failure assessment(SOFA) score	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%.
Hypoalbuminemia	up to 14 days.	below 2,5 g/dl