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

NCT ID: NCT06458387

Last Updated: 2024-06-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 152 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-31
• Study Completion Date: 2027-06-30

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Active protein supplementation

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.

Group Type: EXPERIMENTAL

Active protein supplementation

Intervention Type: 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%.

Conventional protein supplementation

The participants in conventional protein supplementation arm underwent conventional nutrition management without specific protein targets, but less than 1.5 g/kg/day.

Group Type: EXPERIMENTAL

Conventional protein supplementation

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

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%.

Intervention Type: DIETARY_SUPPLEMENT

Conventional protein supplementation

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul St. Mary's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Eun Young Kim

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hye sung Kim

Role: STUDY_DIRECTOR

The Catholic University of Korea

Locations

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

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

Countries

South Korea

Central Contacts

Eun young Kim

Role: CONTACT

freesshs@naver.com

+82-10-4720-0246

Hye sung Kim

Role: CONTACT

dragon90@naver.com

+82-10-6325-5910

Other Identifiers

SeoulSt_HP_01

Identifier Type: -

Identifier Source: org_study_id