Economics of Diarrhoea in Intensive Care Unit

NCT01922570 | Completed

• 1 other identifier: NAC 07-098
• Study Type: interventional
• Target: 305
• Locations: 1 country
• Sites: 1

Brief Summary

Enteral nutrition (EN) is the first choice route for nutritional support in ICU patients with a functioning digestive tract. Nevertheless, EN alone is often associated with digestive intolerance, including diarrhoea. In case of diarrhoea, EN is often reduced or discontinued, resulting in insufficient energy and protein intakes and increase complications rate in ICU patients. Diarrhoea is more frequent in ICU patients receiving EN that in those without EN or on Parenteral nutrition (PN). This difference is likely to be related to the level of EN administration needed to optimize the coverage of nutritional needs at a time when the gut has reduced absorptive capacity. Diarrhoea is suspected to have a negative economic impact on global cost, because the management of patients with diarrhoea is time-consuming for the nurses and all medical staff, it requires investigations (water and electrolytes balances, microbiology investigations, etc.) and treatments (anti-diarrhoeal drugs, antibiotics, etc). However, the economic impact of diarrhoea related to EN or the combination of EN and PN has never been evaluated in the ICU setting.

Conditions

Critical Illness

Keywords

Enteral nutrition; Supplemental parenteral nutrition; Critical illness; ICU patients; diarrhea

Outcome Measures

Primary Outcomes (1)

• Cost of diarrhea

  Swiss francs: All costs (manpower, investigations, treatments) related to diarrhea during the ICU stay up to 28 days are reported as Swiss francs

  day 28

Secondary Outcomes (1)

• Use of enteral nutrition

  day 28

Study Arms (1)

Dietary supplements:parenteral nutrition

EXPERIMENTAL

supplemental parenteral nutrition and enteral nutrition in case of failure (intake below 60% of energy needs) of enteral nutrition by day 3 after admission in the ICU or enteral nutrition only.

Dietary Supplement: nutrition

Interventions

nutrition DIETARY_SUPPLEMENT

comparion of enteral versus enteral and supplemental parenteral nutrition

Also known as: Enteral+parenteral nutrition

Dietary supplements:parenteral nutrition

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with an indication to receive enteral nutrition

You may not qualify if:

• patients with a contraindication to receive enteral nutrition

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (1)

Service of Intensive Care

Geneva, 1211, Switzerland

Location

Related Publications (1)

• Heidegger CP, Graf S, Perneger T, Genton L, Oshima T, Pichard C. The burden of diarrhea in the intensive care unit (ICU-BD). A survey and observational study of the caregivers' opinions and workload. Int J Nurs Stud. 2016 Jul;59:163-8. doi: 10.1016/j.ijnurstu.2016.04.005. Epub 2016 Apr 20.

  PMID: 27222461 DERIVED

MeSH Terms

Conditions

Critical Illness; Diarrhea

Interventions

Nutritional Status

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health Status; Demography; Population Characteristics

Study Officials

• Claude Pichard, MD

  University Hospital, Geneva

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, Clinical Nutrition

Study Record Dates

• First Submitted: June 24, 2013
• First Posted: August 14, 2013
• Study Start: January 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: April 1, 2013
• Last Updated: August 14, 2013

Record last verified: 2013-08

Locations

CH (1)