Comparison of Clinical Outcomes According to High-protein Provision in Critically Ill Patients After Abdominal Surgery

Protein Malnutrition Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06458387
• Other study ID #: SeoulSt_HP_01
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Est. completion date: June 2027

Study information

• Verified date: June 2024
• Source: Seoul St. Mary's Hospital
• Contact: Eun young Kim
• Phone: +82-10-4720-0246
• Email: freesshs[@]naver.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 152
• Est. completion date: June 2027
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients admitted after abdominal surgery to our institution's surgical ICU

• They were enrolled regardless of the surgical method, either open, laparoscopy, or robotic.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Kwashiorkor
• Malnutrition
• Protein Malnutrition

Intervention

Dietary Supplement:
• Active protein supplementation
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 supplementation
The participants in conventional protein supplementation arm received conservative nutritional management without specific protein targets.

Locations

Country	Name	City	State
Korea, Republic of	Division of Trauma and Surgical Critical Care, Department of Surgery, Seoul St. Mary's Hospital	Seoul	Seocho-gu, Banpo-dong Banpodaero 222

Sponsors (1)

Lead Sponsor	Collaborator
Seoul St. Mary's Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6-month mortality rate	Proportion of patients who died within 6 months after surgery among participants	Participants were followed up to 180 days immediately after the surgery
Secondary	30-day mortality rate	Proportion of patients who died within 30 days after surgery among participants	Participants were followed up to 30 days immediately after the surgery
Secondary	90-day mortality rate	Proportion of patients who died within 90 days after surgery among participants	Participants were followed up to 90 days immediately after the surgery
Secondary	Incidence of postoperative complications	Proportion of patients who developed any complications during postoperative hospitalization among participants	Participants were followed during hospitalization (up to 14 days)