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Completed

NCT Number: NCT03170401

Supplemental Enteral Protein in Critical Illness

The aim of this study is too determine the effect of enteral protein supplementation on biochemical measures of inflammation and protein metabolism in critically ill surgical patients. The investigators will also collect data on important clinical outcomes, including infectious complications, duration of mechanical ventilation and other measures of recovery from critical illness.

Hypothesis: That early supplemental protein will increase serum concentrations of transthyretin at three weeks after the onset of illness or injury. Secondarily, the investigators will test whether supplementation, reduces infectious complications and increases ventilator-free days.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Harborview Medical Center

Seattle, Washington, 98104, United States

About this study

Critically ill patients are frequently undernourished. The investigator's observations indicate that surgical and trauma patients who require artificial nutrition are likely to be markedly undernourished during the first week of critical illness, will often require intensive and costly support for organ failure, have prolonged stays in the intensive care unit and extended hospitalizations. Nitrogen deficits are typically greater and receive less attention than caloric deficits. In some respects, the focus on avoiding caloric deficits may have missed the mark. A broader consideration of nutrient needs, such as protein, is required. For instance, there are observational data supporting the notion that protein intake is at least as important as caloric intake in promoting recovery in critical illness. Only recently have national guidelines (ASPEN 2016) begun to specifically address protein requirements (1.5 - 2.0 g/kg/day). For a number of years, the approach to these critically ill patients has included weekly measurements of 24 hour urine nitrogen excretion in order to better understand the protein deficits that develop. Based upon physician preference, the investigators can then use enteral protein supplementation to match the urinary nitrogen excretion in order to achieve net "zero" nitrogen balance. With supplemental protein administration, physicians are able to reduce this deficit and in some cases, generate a positive nitrogen balance. However, there are no data to indicate that this approach (which is included as part of the 2016 ASPEN guidelines) improves clinical outcomes. The most obvious mechanism whereby supplemental protein may influence outcomes by providing more metabolic substrate for protein building. Feeding the gut likely creates a more anabolic environment and additional protein may facilitate anabolism. However, it is not known whether protein supplementation improves markers of anabolism and protein synthesis. In this study, the investigators will measure the anabolic effect of supplemental protein by following serum transthyretin concentrations as part of the standard clinical care.The investigators postulate that supplemental protein will attenuate the drop in comparison to no supplemental protein and will hasten the return to normal concentrations.

The proposed study will test whether early, and standardized protein supplementation: (1) Increases protein delivery during the first 2 weeks after injury, (2) increases serum transthyretin concentrations at 3 weeks after injury (3) increases ventilator-free days.

Study aims:

The aim of this study is to determine the effect of enteral protein supplementation on biochemical measures of protein metabolism in critically ill surgical patients. The investigators will also collect data on important clinical outcomes, including infectious complications, duration of mechanical ventilation and other measures of recovery from critical illness. However, this study will not enroll a sufficient number of subjects to adequately test for differences in these clinical end-points.

Hypothesis: That early supplemental protein will, increase serum concentrations of transthyretin at three weeks after injury. Secondarily, the investigators will test whether supplementation reduces infectious complications and increases ventilator-free days.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Critically ill adult trauma (blunt and penetrating) victims
  • Other critically ill surgical patients
  • enteral nutrition required during the first 96 hours after injury
  • expected to require nutritional support for at least 1 week

Exclusion criteria

  • Significant chronic organ failure,
  • severe malnutrition pre-existing prior to ICU admission
  • not expected to survive from their traumatic injuries.
  • intestinal discontinuity
  • short bowel syndrome
  • bowel obstruction
  • enterocutaneous fistula
  • intestinal ischemia
  • massive gastrointestinal hemorrhage
  • inability to obtain enteral access.

Treatment and study plan

Protein supplementation

Dietary Supplement

enteral protein supplementation

Standard enteral nutrition

Other

Standard enteral nutrition.

Primary outcomes

  1. Serum Concentrations of Transthyretin at 3 Weeks After Injury.

    Time frame: 3 weeks after admission for injury

    Transthyretin is a circulating biomarker of nutritional status and protein synthesis.

Secondary outcomes

  1. Ventilator-free Days.

    Time frame: Within 28 days following admission to hospital following injury.

    Ventilator-free days will measured in the standard way and indicate the number of days a subject was alive and not receiving mechanical ventilation during the first 28 days.

  2. Ventilator Associated Pneumonia.

    Time frame: At any point during the hospitalization.

    Pneumonia diagnosed while the patient is receiving mechanical ventilation as recorded in the institutional administrative trauma registry and ICU quality assurance database.

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Institute of General Medical Sciences (NIGMS)

Registry information

Official study title

Protein-enhanced Enteral Nutrition and Metabolomics in Critically Ill Trauma and Surgical Patients

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
May 31, 2017
Registry last updated
Jun 5, 2024

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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