Gastrointestinal Dysfunction During Enteral Nutrition in Critically Ill Patients

NCT04014816 | Completed

• 1 other identifier: 2014/1870
• Study Type: observational
• Target: 137
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Gastrointestinal Disease; Constipation; Intolerance; Nutritional; Diarrhea

Keywords

ICU

Outcome Measures

Primary Outcomes (1)

• The incidence of GI dysfunction

  Constipation, diarrhea, UDI

  up to 14 days.

Secondary Outcomes (4)

• The sequential organ failure assessment(SOFA) score

  at admission.

• Hypoalbuminemia

  up to 14 days.

• Catecholamine use

  up to 14 days.

• Length of hospital stay

  through study completion, which is 6 months time period.

Study Arms (2)

Group I

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

Other: MDR bacteria positivity; Other: negative fluid balance

Group II

Patients who had normal GI function (Group II) for one or more occasions.

Other: MDR bacteria positivity; Other: negative fluid balance

Interventions

MDR bacteria positivity OTHER

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

Group I; Group II

negative fluid balance OTHER

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

Group I; Group II

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Older than 18 years old. Stay longer than 48 hours at ICU.

You may not qualify if:

• Has enterostomy/colostomy or diagnosis of GI bleeding. Prone position. Laxative drug use. Clostridium Difficile infection positivity.

Sponsors & Collaborators

• Ayancık State Hospital: lead

Related 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.

  PMID: 29503558 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Gastrointestinal Diseases; Constipation; Diarrhea

Condition Hierarchy (Ancestors)

Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Evren Senturk, Assoc. Prof

  Koc University Hospital, Istanbul

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiology Specialist

Study Record Dates

• First Submitted: July 4, 2019
• First Posted: July 10, 2019
• Study Start: January 1, 2015
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: July 10, 2019

Record last verified: 2019-07