Skip to main content
OpenTrials
Completed

NCT Number: NCT04014816

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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MDR bacteria positivity

Other

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

negative fluid balance

Other

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

Primary outcomes

  1. The incidence of GI dysfunction

    Time frame: up to 14 days.

    Constipation, diarrhea, UDI

Secondary outcomes

  1. 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%.

  2. Hypoalbuminemia

    Time frame: up to 14 days.

    below 2,5 g/dl

  3. Catecholamine use

    Time frame: up to 14 days.

    mcg

  4. Length of hospital stay

    Time frame: through study completion, which is 6 months time period.

    days

Sponsors and collaborators

Lead sponsor

Ayancık State Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jul 10, 2019
Registry last updated
Jul 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.