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Completed

NCT Number: NCT03048487

Protein Consumption in Critically Ill Patients

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.

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Key information

Conditions

Critical Illness Dietary Modification Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Geisinger Medical Center, Danville, Pennsylvania, United States

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About this study

This retrospective study of critically ill adults receiving enteral nutrition will assess the ability to meet estimated protein and energy needs via enteral nutrition.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Daily protein intake (from Parenteral Nutrition, Enteral Nutrition, oral diet, and medication)

    Time frame: Daily up to 7 days of ICU stay

Secondary outcomes

  1. Enteral formula utilized (Standard, High protein, Very high protein)

    Time frame: Daily up to 7 days of ICU stay

  2. Daily caloric intake (from Parenteral Nutrition, Enteral Nutrition, oral diet, and medication)

    Time frame: Daily up to 7 days of ICU stay

  3. Estimated caloric needs (Kcal/day)

    Time frame: Daily up to 7 days of ICU stay

  4. Method for estimating caloric needs (descriptive name of scale) calorie needs met.

    Time frame: Daily up to 7 days of ICU stay

  5. Percentage of daily caloric needs met (%) calorie needs met.

    Time frame: Daily up to 7 days of ICU stay

  6. Estimated protein needs (grams protein/day)

    Time frame: Daily up to 7 days of ICU stay

  7. Method for estimating protein needs (descriptive name of scale)

    Time frame: Daily up to 7 days of ICU stay

  8. Percentage of daily protein needs met (%)

    Time frame: Daily up to 7 days of ICU stay

  9. Laboratory values (Blood Urea Nitrogen)

    Time frame: Daily up to 7 days of ICU stay

  10. Laboratory values (Creatinine)

    Time frame: Daily up to 7 days of ICU stay

  11. Laboratory values (Aspartate aminotransferase)

    Time frame: Daily up to 7 days of ICU stay

  12. Laboratory values (Alanine transaminase)

    Time frame: Daily up to 7 days of ICU stay

  13. Laboratory values (Glucose)

    Time frame: Daily up to 7 days of ICU stay

  14. Laboratory values (Ammonia)

    Time frame: Daily up to 7 days of ICU stay

  15. Gastrointestinal side effects observed in enterally fed patients in the ICU

    Time frame: Daily up to 7 days of ICU stay

  16. Insulin use

    Time frame: Daily dose up to 7 days of ICU stay

  17. Health Outcomes (Renal failure, Seizures, Encephalopathy, Hyperglycemia, Hypoglycemia)

    Time frame: Daily up to 7 days of ICU stay

  18. Utilization of renal replacement therapy (Yes/No)

    Time frame: Daily up to 7 days of ICU stay

  19. Utilization of medications to manage hepatic encephalopathy (lactulose) (Yes/No)

    Time frame: Daily up to 7 days of ICU stay

  20. Neurocognitive status (Glasgow Coma Scale)

    Time frame: Daily up to 7 days of ICU stay

  21. Presence of delirium (Yes/No)

    Time frame: Daily up to 7 days of ICU stay

  22. ICU Length of Stay

    Time frame: Up to 90 Days

  23. Hospital Length of Stay

    Time frame: Up to 90 Days

  24. Ventilator days

    Time frame: Up to 90 Days

  25. Antibiotic therapy days

    Time frame: Up to 90 Days

  26. 30 day readmission

    Time frame: Incidence up to 30 days post discharge

  27. Death during hospitalization (Yes/No)

    Time frame: Through study completion, assessed an estimated 36 months

  28. 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.

  29. Discharge against medical advice (Yes/No)

    Time frame: Through study completion, assessed an estimated 36 months

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Collaborators

  • Geisinger Clinic

Registry information

Official study title

Protein Consumption in Critically Ill Patients: A Retrospective Study

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Feb 9, 2017
Registry last updated
Nov 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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