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Status unknownNCT03277300Updated Sep 11, 2017

Enteral and Parenteral Feeding in Critically Ill Patients

An observational study in Critical Illness, sponsored by Assiut University. Status unknown. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-09-11.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Sep 2017), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years to 75 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Critical Illness

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03

In context

Critical Illness

1,780 studies on the registry are indexed under Critical Illness; 442 are open to participants now.

This study's planned enrollment of 100 is below the median of 140 across 814 observational studies indexed under Critical Illness.

Browse Critical Illness studies →

Lead sponsor

Assiut University is the lead sponsor of 5,079 studies on the registry; 2,177 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • No exclusion criteria
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Interventions

  • Dietary supplementdietary supplement

    good dietary supplement for critically ill patients

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What researchers measure

Primary outcomes

  1. ts Overall mortality

    Determined by hospital records.

    Time frame: one year

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • DerSimonian R, Laird N. Meta-analysis in clinical trials. Control Clin Trials. 1986 Sep;7(3):177-88. doi: 10.1016/0197-2456(86)90046-2. PubMed 3802833 ↗
  • 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. PubMed 19851094 ↗
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jan 2018; primary completion for Jan 2019, 12 months later.

Of 439 non-industry observational studies under Critical Illness, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 45. This study's planned 12 months is below that.

Counting every sponsor, half of 442 studies reached it within 23 months; a quarter within 12 and three quarters within 46.

Critical Illness covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 28, 2017
First posted
Sep 11, 2017
StartEst.
Jan 1, 2018
Primary completionEst.
Jan 1, 2019
CompletionEst.
Jan 30, 2019
Last update
Sep 11, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 11, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03277300
Lead sponsor
Assiut University
Responsible party
Ahmed Mohamed Abdelhamid (doctor, Assiut University) — Principal investigator
First posted
Sep 11, 2017
Start date
Jan 1, 2018 (estimated)
Primary completion
Jan 1, 2019 (estimated)
Completion
Jan 30, 2019 (estimated)
Last update
Sep 11, 2017

Study contacts

Ahmed Mohamed
Contact
ahmedeltemway1989@outlook.com
+2001140148703
NoorEldeen AbdElazeem, professor
study chair · Assiut University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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