Protein-Energy MalnutritionNCT06058247
Reducing In-Hospital and 60-Day Mortality in ICU Patients After Surgery With Strict Nutritional Supplementation
A study testing Active nutritional supplementation and Conventional nutritional supplementation in people with Protein-Energy Malnutrition, run by Seoul St. Mary's Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Protein-Energy Malnutrition
- What is being tested?
- Active nutritional supplementation and Conventional nutritional supplementation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 368 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Mar 2019to 1 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients admitted after abdominal surgery to our institution's surgical ICU
- They were enrolled regardless of the surgical method, either open, laparoscopy, or robotic.
Who cannot join
- aged under 18 years
- underwent surgery under local or regional anesthesia
- pregnant
- readmitted to the ICU
- diagnosed with renal failure and receiving renal replacement therapy
- lacked individual data necessary to calculate the mNUTRIC score measured at ICU admission
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- failed to provide informed consent, or with 'do-not-resuscitate' status.
- the patient was discharged or expired within 48 hours of ICU admission
- patients diagnosed with multiorgan failure, represented by a high Sequential Organ Failure Assessment (SOFA) score (≥9) upon ICU admission
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Division of Trauma and Surgical Critical Care, Department of Surgery, Seoul St. Mary's Hospital
Seoul, Seocho-gu, Banpo-dong Banpodaero 222, 137-701
About this study
Official title: Reducing In-Hospital and 60-Day Mortality in Critically Ill Patients After Surgery With Strict Nutritional Supplementation: A Prospective, Single-Labeled, Randomized Controlled Trial
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.
Read the detailed 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.
- Conditions
- Protein-Energy Malnutrition
- Being tested
- Active nutritional supplementation, Conventional nutritional supplementation
- Medical subject headings
- Protein-Energy Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active nutritional supplementationDietary supplement
The participants in active nutritional supplementation arm received consultation from the nutritional support team (NST) upon ICU admission, and nutritional supplementation was initiated on the same day.
NST is a multidisciplinary support team comprised of physicians, nurses, dietitians, and pharmacists, which assesses the nutritional status of patients, and provides recommendations for nutritional therapy. Targets in the participants in active nutritional supplementation arm were protein supplementation at over 1.5 g/kg/day, calorie provision at over 20 kcal/kg/day, and energy adequacy of at least 80%. Energy target was estimated by multiplying the resting energy expenditure using the Harris and Benedict equation by an activity factor of 1.3 and a stress factor of 1.1. Actual body weight was used as the body weight for patients with a percent of ideal body weight (PIBW) of less than 120%, while adjusted body weight was used for patients with a PIBW greater than or equal to 120%.
Conventional nutritional supplementationDietary supplement
The participants in conventional nutritional supplementation arm received conservative nutritional management without specific protein or caloric targets.
| Study group | Role | What they receive |
|---|---|---|
| Active nutritional supplementation | Experimental | The participants in active nutritional supplementation arm received nutritional support targeting specific protein (over 1.5 g/kg/day) and calorie intake (over 20 kcal/kg/day), with consultation from the nutritional support team and the initiation of nutritional supplementation on the same day as intensive care unit admission. Receives: Dietary Supplement: Active nutritional supplementation |
| Conventional nutritional supplementation | Experimental | The participants in conventional nutritional supplementation arm underwent conventional nutrition management without specific protein or caloric targets. Receives: Dietary Supplement: Conventional nutritional supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
60-day mortality rate
Proportion of patients who died within 60 days after surgery among participants
Measured: Participants were followed upto 60th day after surgery
Secondary outcomes (2)
In-hospital mortality rate
Proportion of patients who died during the hospitalization period
Measured: Participants were followed upto 60th day after surgery
Incidence of postoperative complications
Proportion of patients who died within 60 days after surgery among participants
Measured: Participants were followed upto 60th day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start1 Mar 2019
- Primary completion1 Aug 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Protein-Energy MalnutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 368 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul St. Mary's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eun Young Kim, Seoul St. Mary's Hospital
- Investigators
- Hye sung Kim, Study director, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06058247
- Sponsor's protocol ID
- NUMIS_02
- Status last verified
- Sep 2023
- First submitted
- 5 Sep 2023
- Last updated
- 28 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing In-Hospital and 60-Day Mortality in Critically Ill Patients After Surgery With Strict Nutritional Supplementation: A Prospective, Single-Labeled, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06058247
- Acronym / sponsor ID
- NUMIS_02
- Conditions
- Protein-Energy Malnutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 368 participants (actual)
- Lead sponsor
- Seoul St. Mary's HospitalUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 28 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active nutritional supplementation | Experimental | Dietary Supplement: Active nutritional supplementationThe participants in active nutritional supplementation arm received nutritional support targeting specific protein (over 1.5 g/kg/day) and calorie intake (over 20 kcal/kg/day), with consultation from the nutritional support team and the initiation of nutritional supplementation on the same day as intensive care unit admission. |
| Conventional nutritional supplementation | Experimental | Dietary Supplement: Conventional nutritional supplementationThe participants in conventional nutritional supplementation arm underwent conventional nutrition management without specific protein or caloric targets. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients admitted after abdominal surgery to our institution's surgical ICU
- They were enrolled regardless of the surgical method, either open, laparoscopy, or robotic.
Key exclusion criteria (9 listed)
- aged under 18 years
- underwent surgery under local or regional anesthesia
- pregnant
- readmitted to the ICU
- diagnosed with renal failure and receiving renal replacement therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active nutritional supplementationThe participants in active nutritional supplementation arm received consultation from the nutritional support team (NST) upon ICU admission, and nutritional supplementation was initiated on the same day. NST is a multidisciplinary support team comprised of physicians, nurses, dietitians, and pharmacists, which assesses the nutritional status of patients, and provides recommendations for nutritional therapy. Targets in the participants in active nutritional supplementation arm were protein supplementation at over 1.5 g/kg/day, calorie provision at over 20 kcal/kg/day, and energy adequacy of at least 80%. Energy target was estimated by multiplying the resting energy expenditure using the Harris and Benedict equation by an activity factor of 1.3 and a stress factor of 1.1. Actual body weight was used as the body weight for patients with a percent of ideal body weight (PIBW) of less than 120%, while adjusted body weight was used for patients with a PIBW greater than or equal to 120%. | Dietary supplement | Active nutritional supplementation |
| Conventional nutritional supplementationThe participants in conventional nutritional supplementation arm received conservative nutritional management without specific protein or caloric targets. | Dietary supplement | Conventional nutritional supplementation |
Primary outcome
60-day mortality rate
Time frame: Participants were followed upto 60th day after surgery
Proportion of patients who died within 60 days after surgery among participants
2 secondary outcomes
In-hospital mortality rate
Time frame: Participants were followed upto 60th day after surgery
Incidence of postoperative complications
Time frame: Participants were followed upto 60th day after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hye sung Kim study director
The Catholic University of Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active nutritional supplementation and Conventional nutritional supplementation in people with Protein-Energy Malnutrition, run by Seoul St. Mary's Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
60-day mortality rate (time frame: Participants were followed upto 60th day after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.