Critical IllnessNCT03048487
Protein Consumption in Critically Ill Patients
An observational study of Critical Illness and Dietary Modification, run by Société des Produits Nestlé (SPN) at 3 sites in United States.
Trial summary
A retrospective study of protein intake and needs as well as outcomes in critically ill adult patients. Data will be collected for up to 7 days of ICU stay. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Dietary Modification
- How many people
- 2,000 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2016to Sep 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will include all patients with an ICU admission receiving enteral nutrition in a 36-month period.
Who may be able to join
- Adult patients (age ≥18 years)
- Admitted to the ICU
- Administered at least one dose of enteral formula
Who cannot join
- Receiving exclusive oral or exclusive parenteral nutrition
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Geisinger Medical Center
Danville, Pennsylvania, 17822
Geisinger Community Medical Center, Scranton, PA
Scranton, Pennsylvania, 18510
Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, 18711
About this study
Official title: Protein Consumption in Critically Ill Patients: A Retrospective Study
A retrospective study of protein intake and needs as well as outcomes in critically ill adult patients. Data will be collected for up to 7 days of ICU stay.
Read the detailed description
This retrospective study of critically ill adults receiving enteral nutrition will assess the ability to meet estimated protein and energy needs via enteral nutrition.
- Conditions
- Critical Illness, Dietary Modification
- Medical subject headings
- Critical Illness
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily protein intake (from Parenteral Nutrition, Enteral Nutrition, oral diet, and medication)
Measured: Daily up to 7 days of ICU stay
Secondary outcomes (29)
Enteral formula utilized (Standard, High protein, Very high protein)
Measured: Daily up to 7 days of ICU stay
Daily caloric intake (from Parenteral Nutrition, Enteral Nutrition, oral diet, and medication)
Measured: Daily up to 7 days of ICU stay
Estimated caloric needs (Kcal/day)
Measured: Daily up to 7 days of ICU stay
Method for estimating caloric needs (descriptive name of scale) calorie needs met.
Measured: Daily up to 7 days of ICU stay
Percentage of daily caloric needs met (%) calorie needs met.
Measured: Daily up to 7 days of ICU stay
Estimated protein needs (grams protein/day)
Measured: Daily up to 7 days of ICU stay
Method for estimating protein needs (descriptive name of scale)
Measured: Daily up to 7 days of ICU stay
Percentage of daily protein needs met (%)
Measured: Daily up to 7 days of ICU stay
Laboratory values (Blood Urea Nitrogen)
Measured: Daily up to 7 days of ICU stay
Laboratory values (Creatinine)
Measured: Daily up to 7 days of ICU stay
Laboratory values (Aspartate aminotransferase)
Measured: Daily up to 7 days of ICU stay
Laboratory values (Alanine transaminase)
Measured: Daily up to 7 days of ICU stay
Laboratory values (Glucose)
Measured: Daily up to 7 days of ICU stay
Laboratory values (Ammonia)
Measured: Daily up to 7 days of ICU stay
Gastrointestinal side effects observed in enterally fed patients in the ICU
Measured: Daily up to 7 days of ICU stay
Insulin use
Measured: Daily dose up to 7 days of ICU stay
Health Outcomes (Renal failure, Seizures, Encephalopathy, Hyperglycemia, Hypoglycemia)
Measured: Daily up to 7 days of ICU stay
Utilization of renal replacement therapy (Yes/No)
Measured: Daily up to 7 days of ICU stay
Utilization of medications to manage hepatic encephalopathy (lactulose) (Yes/No)
Measured: Daily up to 7 days of ICU stay
Neurocognitive status (Glasgow Coma Scale)
Measured: Daily up to 7 days of ICU stay
Presence of delirium (Yes/No)
Measured: Daily up to 7 days of ICU stay
ICU Length of Stay
Measured: Up to 90 Days
Hospital Length of Stay
Measured: Up to 90 Days
Ventilator days
Measured: Up to 90 Days
Antibiotic therapy days
Measured: Up to 90 Days
30 day readmission
Measured: Incidence up to 30 days post discharge
Death during hospitalization (Yes/No)
Measured: Through study completion, assessed an estimated 36 months
Destination for discharge (home, another acute care hospital, Long Term Acute Care, rehabilitation center, nursing home)
Destination of Discharge will be assessed via chart review.
Measured: Through study completion, assessed an estimated 36 months
Discharge against medical advice (Yes/No)
Measured: Through study completion, assessed an estimated 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2017 (estimated)
- Study startSep 2016
- Primary completionDec 2017
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Geisinger Clinic
- Responsible party
- Sponsor
- Investigators
- Joseph Layon, MD, FACP, Principal investigator, Geisinger Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03048487
- Sponsor's protocol ID
- 16.11.CLI
- Status last verified
- Nov 2018
- First submitted
- 4 Oct 2016
- Last updated
- 6 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protein Consumption in Critically Ill Patients: A Retrospective Study
- ClinicalTrials.gov ID
- NCT03048487
- Acronym / sponsor ID
- 16.11.CLI
- Conditions
- Critical Illness, Dietary Modification
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Collaborators
- Geisinger Clinic
- Study start
- Sep 2016
- Primary completion
- Dec 2017 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 9 Feb 2017 (estimated)
- 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.
A retrospective study of protein intake and needs as well as outcomes in critically ill adult patients. Data will be collected for up to 7 days of ICU stay.
Detailed description
This retrospective study of critically ill adults receiving enteral nutrition will assess the ability to meet estimated protein and energy needs via enteral nutrition.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include all patients with an ICU admission receiving enteral nutrition in a 36-month period.
Key inclusion criteria (3 listed)
- Adult patients (age ≥18 years)
- Admitted to the ICU
- Administered at least one dose of enteral formula
Key exclusion criteria (1 listed)
- Receiving exclusive oral or exclusive parenteral nutrition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Daily protein intake (from Parenteral Nutrition, Enteral Nutrition, oral diet, and medication)
Time frame: Daily up to 7 days of ICU stay
29 secondary outcomes
Enteral formula utilized (Standard, High protein, Very high protein)
Time frame: Daily up to 7 days of ICU stay
Daily caloric intake (from Parenteral Nutrition, Enteral Nutrition, oral diet, and medication)
Time frame: Daily up to 7 days of ICU stay
Estimated caloric needs (Kcal/day)
Time frame: Daily up to 7 days of ICU stay
Method for estimating caloric needs (descriptive name of scale) calorie needs met.
Time frame: Daily up to 7 days of ICU stay
Percentage of daily caloric needs met (%) calorie needs met.
Time frame: Daily up to 7 days of ICU stay
Estimated protein needs (grams protein/day)
Time frame: Daily up to 7 days of ICU stay
Method for estimating protein needs (descriptive name of scale)
Time frame: Daily up to 7 days of ICU stay
Percentage of daily protein needs met (%)
Time frame: Daily up to 7 days of ICU stay
Laboratory values (Blood Urea Nitrogen)
Time frame: Daily up to 7 days of ICU stay
Laboratory values (Creatinine)
Time frame: Daily up to 7 days of ICU stay
Laboratory values (Aspartate aminotransferase)
Time frame: Daily up to 7 days of ICU stay
Laboratory values (Alanine transaminase)
Time frame: Daily up to 7 days of ICU stay
Laboratory values (Glucose)
Time frame: Daily up to 7 days of ICU stay
Laboratory values (Ammonia)
Time frame: Daily up to 7 days of ICU stay
Gastrointestinal side effects observed in enterally fed patients in the ICU
Time frame: Daily up to 7 days of ICU stay
Insulin use
Time frame: Daily dose up to 7 days of ICU stay
Health Outcomes (Renal failure, Seizures, Encephalopathy, Hyperglycemia, Hypoglycemia)
Time frame: Daily up to 7 days of ICU stay
Utilization of renal replacement therapy (Yes/No)
Time frame: Daily up to 7 days of ICU stay
Utilization of medications to manage hepatic encephalopathy (lactulose) (Yes/No)
Time frame: Daily up to 7 days of ICU stay
Neurocognitive status (Glasgow Coma Scale)
Time frame: Daily up to 7 days of ICU stay
Presence of delirium (Yes/No)
Time frame: Daily up to 7 days of ICU stay
ICU Length of Stay
Time frame: Up to 90 Days
Hospital Length of Stay
Time frame: Up to 90 Days
Ventilator days
Time frame: Up to 90 Days
Antibiotic therapy days
Time frame: Up to 90 Days
30 day readmission
Time frame: Incidence up to 30 days post discharge
Death during hospitalization (Yes/No)
Time frame: Through study completion, assessed an estimated 36 months
Destination for discharge (home, another acute care hospital, Long Term Acute Care, rehabilitation center, nursing home)
Time frame: Through study completion, assessed an estimated 36 months
Discharge against medical advice (Yes/No)
Time frame: Through study completion, assessed an estimated 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2018.
- Individual participant dataSharing planned: No
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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.
Joseph Layon, MD, FACP principal investigator
Geisinger Clinic
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness and Dietary Modification, run by Société des Produits Nestlé (SPN) at 3 sites in United States.
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 3 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: finished, as of the sponsor's last update on 6 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily protein intake (from Parenteral Nutrition, Enteral Nutrition, oral diet, and medication) (time frame: Daily up to 7 days of ICU stay). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Nov 2018; AzTrials last refreshed its copy on 28 Oct 2026.