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

NCT06458387 | Not Yet Recruiting

• 1 other identifier: SeoulSt_HP_01
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Protein Malnutrition

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 30-day mortality rate

  Participants were followed up to 30 days immediately after the surgery

• 90-day mortality rate

  Participants were followed up to 90 days immediately after the surgery

• Incidence of postoperative complications

  Participants were followed during hospitalization (up to 14 days)

Study Arms (2)

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.

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.

Dietary Supplement: Conventional protein supplementation

Interventions

Active protein supplementation DIETARY_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%.

Active protein supplementation

Conventional protein supplementation DIETARY_SUPPLEMENT

The participants in conventional protein supplementation arm received conservative nutritional management without specific protein targets.

Conventional protein supplementation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients admitted after abdominal surgery to our institution's surgical ICU
• They were enrolled regardless of the surgical method, either open, laparoscopy, or robotic.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seoul St. Mary's Hospital: lead

Study Sites (1)

Division of Trauma and Surgical Critical Care, Department of Surgery, Seoul St. Mary's Hospital

Seoul, Seocho-gu, Banpo-dong Banpodaero 222, 137-701, South Korea

Location

MeSH Terms

Conditions

Kwashiorkor

Condition Hierarchy (Ancestors)

Severe Acute Malnutrition; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Hye sung Kim

  The Catholic University of Korea

  STUDY DIRECTOR

Central Study Contacts

Eun young Kim

CONTACT

+82-10-4720-0246; freesshs@naver.com

Hye sung Kim

CONTACT

+82-10-6325-5910; dragon90@naver.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 5, 2024
• First Posted: June 13, 2024
• Study Start: July 1, 2024
• Primary Completion: January 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: June 13, 2024

Record last verified: 2024-06

Locations

KR (1)