Critical IllnessNCT03277300
Enteral and Parenteral Feeding in Critically Ill Patients
An observational study of Critical Illness, run by Assiut University.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Critical Illness
- What is being tested?
- dietary supplement
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2018to 30 Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- No exclusion criteria
Trial locations and contacts
No sites are listed yet.
About this study
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.
- Conditions
- Critical Illness
- Being tested
- dietary supplement
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dietary supplementDietary supplement
good dietary supplement for critically ill patients
What is being measured
The primary outcome is the main question the study is designed to answer.
ts Overall mortality
Determined by hospital records.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2017
- Study start1 Jan 2018 (estimated)
- Primary completion1 Jan 2019 (estimated)
- Study completion30 Jan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Abdelhamid, Assiut University
- Investigators
- NoorEldeen AbdElazeem, professor, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03277300
- Sponsor's protocol ID
- EN&PN
- Status last verified
- Sep 2017
- First submitted
- 28 Aug 2017
- Last updated
- 11 Sep 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 3802833Cahill 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
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enteral and Parenteral Feeding in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT03277300
- Acronym / sponsor ID
- EN&PN
- Conditions
- Critical Illness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (estimated)
- Primary completion
- 1 Jan 2019 (estimated)
- Study completion
- 30 Jan 2019 (estimated)
- First posted
- 11 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Supplementation of insufficient enteral nutrition with parenteral nutrition may optimize nutritional support and avert negative energy balance in critically ill patients, thereby improving outcome.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- No exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dietary supplementgood dietary supplement for critically ill patients | Dietary supplement | – |
Primary outcome
ts Overall mortality
Time frame: one year
Determined by hospital records.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2017.
- Background: PubMed 3802833DerSimonian 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.
- Background: PubMed 19851094Cahill 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
NoorEldeen AbdElazeem, professor study chair
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Mohamed (+2001140148703, ahmedeltemway1989@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ts Overall mortality (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03277300, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2017.