Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03170401 |
Other study ID # |
STUDY00007918 |
Secondary ID |
1R01GM127790-01A |
Status |
Completed |
Phase |
Phase 3
|
First received |
|
Last updated |
|
Start date |
November 2016 |
Est. completion date |
December 2022 |
Study information
Verified date |
May 2024 |
Source |
University of Washington |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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.