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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03277300
Other study ID # EN&PN
Secondary ID
Status Not yet recruiting
Phase N/A
First received August 28, 2017
Last updated September 7, 2017
Start date January 1, 2018
Est. completion date January 30, 2019

Study information

Verified date September 2017
Source Assiut University
Contact Ahmed Mohamed
Phone +2001140148703
Email ahmedeltemway1989@outlook.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Supplementation of insufficient enteral nutrition with parenteral nutrition may optimize nutritional support and avert negative energy balance in critically ill patients, thereby improving outcome.


Description:

Malnutrition is a common and serious problem in intensive care units. Negative energy balance has been associated with increased morbidity and mortality in critically ill patients. The increased incidence of complications related to malnutrition correlates with increased length of hospital stay and overall health care costs. Although early enteral nutrition is the preferred method of feeding critically ill patients, enteral nutrition alone often fails to supply adequate calories and nutrients to critically ill patients, who are frequently hypermetabolic.

Artificial nutrition support has evolved into a primary therapeutic intervention to prevent metabolic deterioration and loss of lean body mass with the aim to improve the outcome of critically ill patients. Apart from the timing of initiation and the targeted amount of macronutrients, the route of delivery is viewed as an important determinant of the effect of the nutritional intervention.

Using the enteral route is considered to be more physiologic, providing nutritional and various non-nutritional benefits including maintenance of structural and functional gut integrity as well as preserving intestinal microbial diversity.

The disadvantage of enteral nutrition is related to a potential lower nutritional adequacy particularly in the acute disease phase and in the presence of gastrointestinal dysfunction.

In contrast, parenteral nutrition may better secure the intended nutritional intake but is associated with more infectious complications, most likely due to hyperalimentation and hyperglycemia.

Supplementation of insufficient enteral nutrition with parenteral nutrition may optimize nutritional support and avert negative energy balance in critically ill patients, thereby improving outcome.

Combining parenteral nutrition with enteral nutrition constitutes a strategy to prevent nutritional deficit but may increase risk of overfeeding, which has been associated with liver dysfunction, infection, and prolonged ventilatory support.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date January 30, 2019
Est. primary completion date January 1, 2019
Accepts healthy volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- All patients admitted to CCU (critical care unit)who are in need for either enteral or parenteral during duration of the study will be included

Exclusion Criteria:

- No exclusion criteria

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
dietary supplement
good dietary supplement for critically ill patients

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (2)

Cahill NE, Dhaliwal R, Day AG, Jiang X, Heyland DK. Nutrition therapy in the critical care setting: what is "best achievable" practice? An international multicenter observational study. Crit Care Med. 2010 Feb;38(2):395-401. doi: 10.1097/CCM.0b013e3181c0263d. — View Citation

DerSimonian R, Laird N. Meta-analysis in clinical trials. Control Clin Trials. 1986 Sep;7(3):177-88. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary ts Overall mortality Determined by hospital records. one year
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