Gastrointestinal Dysfunction During Enteral Nutrition in Critically Ill Patients

Constipation Clinical Trial

Official title:

The Frequency, Risk Factors, and Complications of Gastrointestinal Dysfunction During Enteral Nutrition in Critically Ill Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04014816
• Other study ID #: 2014/1870
• Status: Completed
• Start date: January 1, 2015
• Est. completion date: July 1, 2015

Study information

• Verified date: July 2019
• Source: Ayancik State Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 137
• Est. completion date: July 1, 2015
• Est. primary completion date: July 1, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Constipation
• Critical Illness
• Diarrhea
• Digestive System Diseases
• Gastrointestinal Disease
• Gastrointestinal Diseases
• Intolerance; Nutritional

Intervention

Other:
• MDR bacteria positivity
A total of 137 patients who received nasogastric tube feeding in an ICU of a tertiary hospital were enrolled.
• negative fluid balance
A total of 137 patients who received nasogastric tube feeding in an ICU of a tertiary hospital were enrolled.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ayancik State Hospital

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of GI dysfunction	Constipation, diarrhea, UDI	up to 14 days.
Secondary	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%.	at admission.
Secondary	Hypoalbuminemia	below 2,5 g/dl	up to 14 days.
Secondary	Catecholamine use	mcg	up to 14 days.
Secondary	Length of hospital stay	days	through study completion, which is 6 months time period.

External Links

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