ClinicalTrials.gov
ClinicalTrials.gov Menu

Enteral and Parenteral Feeding in Critically Ill Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03277300
Recruitment Status : Not yet recruiting
First Posted : September 11, 2017
Last Update Posted : September 11, 2017
Sponsor:
Information provided by (Responsible Party):
Ahmed Mohamed Abdelhamid, Assiut University

Brief 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.

Condition or disease Intervention/treatment
Critical Illness Dietary Supplement: dietary supplement

Detailed 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.


Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Enteral and Parenteral Feeding in Critically Ill Patients
Estimated Study Start Date : January 1, 2018
Estimated Primary Completion Date : January 1, 2019
Estimated Study Completion Date : January 30, 2019

Resource links provided by the National Library of Medicine



Intervention Details:
  • Dietary Supplement: dietary supplement
    good dietary supplement for critically ill patients


Primary Outcome Measures :
  1. ts Overall mortality [ Time Frame: one year ]
    Determined by hospital records.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Data will be collected and analyzed using SPSS version 20. Normally distributed data will be expressed in form of mean and SD while not normally distributed data will be expressed in form of median and range. Nominal data will be expressed in form of frequency (percentage). P value will be significant if < 0.05.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03277300


Contacts
Contact: Ahmed Mohamed +2001140148703 ahmedeltemway1989@outlook.com

Sponsors and Collaborators
Assiut University
Investigators
Study Chair: NoorEldeen AbdElazeem, professor Assiut University

Publications:
Responsible Party: Ahmed Mohamed Abdelhamid, doctor, Assiut University
ClinicalTrials.gov Identifier: NCT03277300     History of Changes
Other Study ID Numbers: EN&PN
First Posted: September 11, 2017    Key Record Dates
Last Update Posted: September 11, 2017
Last Verified: September 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes