Protein MalnutritionNCT06458387
Comparison of Clinical Outcomes According to High-protein Provision in Critically Ill Patients After Abdominal Surgery
A study testing Active protein supplementation and Conventional protein supplementation in people with Protein Malnutrition, run by Seoul St. Mary's Hospital at 1 site in South Korea.
Trial summary
Protein malnutrition in critically ill patients is a global concern due to its association with 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 Malnutrition
- What is being tested?
- Active protein supplementation and Conventional protein supplementation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2024to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 due to any cause
- diagnosed with renal failure and receiving renal replacement therapy
- patients diagnosed with multiorgan failure, represented by a high Sequential Organ Failure Assessment (SOFA) score (≥9) upon ICU admission
- failed to provide informed consent, or with 'do-not-resuscitate' status.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
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: Comparison of Clinical Outcomes According to High-protein Provision Through Parenteral Nutrition in Critically Ill Patients Immediately After Abdominal Surgery: a Prospective, Single-blinded, Randomized Controlled Trial
Protein malnutrition in critically ill patients is a global concern due to its association with 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, the optimal target of protein supplementation remains controversial.
The investigators aimed to evaluate the effects of high protein provision, targeting a protein intake of at least 1.5 g/kg/day for the first 3 days after abdominal surgery, on 6-month 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 protein provision 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 vary according to different guidelines, and this is the same for surgical patients. Recent randomized controlled trials reported conflicting results with current guidelines, with some suggesting that higher protein dose administrations did not significantly impact clinical outcomes and may even worsen the outcomes for certain patient groups. Thus, the optimal protein provision target during the acute phase of critical illness, particularly for surgical patients, remains controversial.
The investigators aimed to assess the effects of strict high protein provision between the high protein group (protein target supplemented with 1.5 g/kg/day) and the control group (protein target supplemented with less than 1.5 g/kg/day) using intravenous nutrient solution for the first 3 days after abdominal surgery. Additionally, the investigators investigated the appropriate target for protein provision in critically ill patients who undergo abdominal surgery.
- Conditions
- Protein Malnutrition
- Being tested
- Active protein supplementation, Conventional protein supplementation
- Medical subject headings
- Kwashiorkor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active protein 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 protein supplementation arm were protein supplementation at over 1.5 g/kg/day during first 3 days after ICU admission. 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 protein supplementationDietary supplement
The participants in conventional protein supplementation arm received conservative nutritional management without specific protein targets.
| Study group | Role | What they receive |
|---|---|---|
| Active protein supplementation | Experimental | The participants in active nutritional supplementation arm received nutritional support targeting specific protein (over 1.5 g/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 protein supplementation |
| Conventional protein supplementation | Experimental | The participants in conventional protein supplementation arm underwent conventional nutrition management without specific protein targets, but less than 1.5 g/kg/day. Receives: Dietary Supplement: Conventional protein supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-month mortality rate
Proportion of patients who died within 6 months after surgery among participants
Measured: Participants were followed up to 180 days immediately after the surgery
Secondary outcomes (3)
30-day mortality rate
Proportion of patients who died within 30 days after surgery among participants
Measured: Participants were followed up to 30 days immediately after the surgery
90-day mortality rate
Proportion of patients who died within 90 days after surgery among participants
Measured: Participants were followed up to 90 days immediately after the surgery
Incidence of postoperative complications
Proportion of patients who developed any complications during postoperative hospitalization among participants
Measured: Participants were followed during hospitalization (up to 14 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study startJul 2024 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Protein 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
- 152 participants (estimated)
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
- NCT06458387
- Sponsor's protocol ID
- SeoulSt_HP_01
- Status last verified
- Jun 2024
- First submitted
- 5 Jun 2024
- Last updated
- 13 Jun 2024
- 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 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Clinical Outcomes According to High-protein Provision Through Parenteral Nutrition in Critically Ill Patients Immediately After Abdominal Surgery: a Prospective, Single-blinded, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06458387
- Acronym / sponsor ID
- SeoulSt_HP_01
- Conditions
- Protein Malnutrition
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- Seoul St. Mary's HospitalUniversity, hospital or other
- Study start
- Jul 2024 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 13 Jun 2024 (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.
Protein malnutrition in critically ill patients is a global concern due to its association with 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, the optimal target of protein supplementation remains controversial.
The investigators aimed to evaluate the effects of high protein provision, targeting a protein intake of at least 1.5 g/kg/day for the first 3 days after abdominal surgery, on 6-month 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 protein provision 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 vary according to different guidelines, and this is the same for surgical patients. Recent randomized controlled trials reported conflicting results with current guidelines, with some suggesting that higher protein dose administrations did not significantly impact clinical outcomes and may even worsen the outcomes for certain patient groups. Thus, the optimal protein provision target during the acute phase of critical illness, particularly for surgical patients, remains controversial.
The investigators aimed to assess the effects of strict high protein provision between the high protein group (protein target supplemented with 1.5 g/kg/day) and the control group (protein target supplemented with less than 1.5 g/kg/day) using intravenous nutrient solution for the first 3 days after abdominal surgery. Additionally, the investigators investigated the appropriate target for protein provision 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 protein supplementation | Experimental | Dietary Supplement: Active protein supplementationThe participants in active nutritional supplementation arm received nutritional support targeting specific protein (over 1.5 g/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 protein supplementation | Experimental | Dietary Supplement: Conventional protein supplementationThe participants in conventional protein supplementation arm underwent conventional nutrition management without specific protein targets, but less than 1.5 g/kg/day. |
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 (7 listed)
- aged under 18 years
- underwent surgery under local or regional anesthesia
- pregnant
- readmitted to the ICU due to any cause
- 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 protein 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 protein supplementation arm were protein supplementation at over 1.5 g/kg/day during first 3 days after ICU admission. 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 protein supplementation |
| Conventional protein supplementationThe participants in conventional protein supplementation arm received conservative nutritional management without specific protein targets. | Dietary supplement | Conventional protein supplementation |
Primary outcome
6-month mortality rate
Time frame: Participants were followed up to 180 days immediately after the surgery
Proportion of patients who died within 6 months after surgery among participants
3 secondary outcomes
30-day mortality rate
Time frame: Participants were followed up to 30 days immediately after the surgery
90-day mortality rate
Time frame: Participants were followed up to 90 days immediately after the surgery
Incidence of postoperative complications
Time frame: Participants were followed during hospitalization (up to 14 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
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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.
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 protein supplementation and Conventional protein supplementation in people with Protein 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 7 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: opening soon, as of the sponsor's last update on 13 Jun 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eun young Kim (+82-10-4720-0246, freesshs@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-month mortality rate (time frame: Participants were followed up to 180 days immediately after the 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 13 Jun 2024.