Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT06058247 |
Other study ID # |
NUMIS_02 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
March 1, 2019 |
Est. completion date |
August 1, 2022 |
Study information
Verified date |
September 2023 |
Source |
Seoul St. Mary's Hospital |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Malnutrition in critically ill patients is a global concern due to its association with
increased infectious complications, prolonged hospital stays, and higher morbidity rates.
Patients who undergo abdominal surgery are particularly vulnerable due to alterations in
gastrointestinal function and prolonged fasting. Despite the significance of proper
nutrition, guidelines remain broad, and practical implementation is often inadequate.
The investigators aimed to assess the effects of strict nutritional provision, targeting an
energy adequacy of 80% or more and a protein intake of at least 1.5 g/kg/day, on in-hospital
and 60-day mortality.
Description:
During the acute phase of critical illness, patients experience metabolic and physiological
changes that affects their nutrition status. One prominent feature is the activation of
stress hormones and inflammatory mediators, which contribute to a negative nitrogen balance,
increased gluconeogenesis, and accelerated muscle proteolysis. Among these patients, those
who undergo abdominal surgery are particularly vulnerable to malnutrition as they experience
alterations in the structural barrier of the gastrointestinal tract, impaired nutrient
absorption, and prolonged fasting due to concerns such as the integrity of an anastomosis.
Thus, appropriate nutritional therapy should be prioritized for critically ill patients
following abdominal surgery, and it should include adequate nutritional support to preserve
lean body mass and organ function.
Despite the importance of nutritional supply, the recommendations for protein or calorie
intake vary according to different guidelines, and this is the same for surgical patients.
Additionally, some patients experience a delay in initiating nutritional support, and several
studies reported that only 39 - 63% of the intended energy and 45 - 55% of the prescribed
protein are being administered to critically ill patients during the acute phase.
Furthermore, recent randomized controlled trials reported conflicting results with current
guidelines, with some suggesting that lower calorie or higher protein dose administrations
did not significantly impact clinical outcomes and may even worsen the outcomes for certain
patient groups. Thus, the optimal nutritional provision target during the acute phase of
critical illness, particularly for surgical patients, remains controversial, and there is no
standardized protocol.
In our previous study, the malnutrition status upon admission, indicated by a modified
Nutrition Risk in the Critically Ill (mNUTRIC) score of 5 or higher, and low energy adequacy
during intensive care unit (ICU) stay were identified as mortality predictors in critically
ill patients following abdominal surgery. The investigators aimed to assess the effects of
strict nutritional provision, targeting an energy adequacy of 80% or more and a protein
intake of at least 1.5 g/kg/day, on in-hospital and 60-day mortality. Additionally, the
investigators investigated the appropriate target for nutrition support in critically ill
patients who undergo abdominal surgery.