Protein Consumption in Critically Ill Patients

November 2, 2018 updated by: Société des Produits Nestlé (SPN)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822
        • Geisinger Medical Center
      • Scranton, Pennsylvania, United States, 18510
        • Geisinger Community Medical Center, Scranton, PA
      • Wilkes-Barre, Pennsylvania, United States, 18711
        • Geisinger Wyoming Valley Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The study population will include all patients with an ICU admission receiving enteral nutrition in a 36-month period.

Description

Inclusion Criteria:

  • Adult patients (age ≥18 years)
  • Admitted to the ICU
  • Administered at least one dose of enteral formula

Exclusion Criteria:

  • Receiving exclusive oral or exclusive parenteral nutrition

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Daily protein intake (from Parenteral Nutrition, Enteral Nutrition, oral diet, and medication)
Time Frame: Daily up to 7 days of ICU stay
Daily up to 7 days of ICU stay

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Enteral formula utilized (Standard, High protein, Very high protein)
Time Frame: Daily up to 7 days of ICU stay
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
Daily up to 7 days of ICU stay
Estimated caloric needs (Kcal/day)
Time Frame: Daily up to 7 days of ICU stay
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
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
Daily up to 7 days of ICU stay
Estimated protein needs (grams protein/day)
Time Frame: Daily up to 7 days of ICU stay
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
Daily up to 7 days of ICU stay
Percentage of daily protein needs met (%)
Time Frame: Daily up to 7 days of ICU stay
Daily up to 7 days of ICU stay
Laboratory values (Blood Urea Nitrogen)
Time Frame: Daily up to 7 days of ICU stay
Daily up to 7 days of ICU stay
Laboratory values (Creatinine)
Time Frame: Daily up to 7 days of ICU stay
Daily up to 7 days of ICU stay
Laboratory values (Aspartate aminotransferase)
Time Frame: Daily up to 7 days of ICU stay
Daily up to 7 days of ICU stay
Laboratory values (Alanine transaminase)
Time Frame: Daily up to 7 days of ICU stay
Daily up to 7 days of ICU stay
Laboratory values (Glucose)
Time Frame: Daily up to 7 days of ICU stay
Daily up to 7 days of ICU stay
Laboratory values (Ammonia)
Time Frame: Daily up to 7 days of ICU stay
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
Daily up to 7 days of ICU stay
Insulin use
Time Frame: Daily dose up to 7 days of ICU stay
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
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
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
Daily up to 7 days of ICU stay
Neurocognitive status (Glasgow Coma Scale)
Time Frame: Daily up to 7 days of ICU stay
Daily up to 7 days of ICU stay
Presence of delirium (Yes/No)
Time Frame: Daily up to 7 days of ICU stay
Daily up to 7 days of ICU stay
ICU Length of Stay
Time Frame: Up to 90 Days
Up to 90 Days
Hospital Length of Stay
Time Frame: Up to 90 Days
Up to 90 Days
Ventilator days
Time Frame: Up to 90 Days
Up to 90 Days
Antibiotic therapy days
Time Frame: Up to 90 Days
Up to 90 Days
30 day readmission
Time Frame: Incidence up to 30 days post discharge
Incidence up to 30 days post discharge
Death during hospitalization (Yes/No)
Time Frame: Through study completion, assessed an estimated 36 months
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
Destination of Discharge will be assessed via chart review.
Through study completion, assessed an estimated 36 months
Discharge against medical advice (Yes/No)
Time Frame: Through study completion, assessed an estimated 36 months
Through study completion, assessed an estimated 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Société des Produits Nestlé (SPN)

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Geisinger Clinic

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Joseph Layon, MD, FACP, Geisinger Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 4, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2017

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 9, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 6, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 2, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 16.11.CLI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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