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NCT Number: NCT06458387

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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%.

Conventional protein supplementation

Dietary Supplement

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 30-day mortality rate

    Time frame: Participants were followed up to 30 days immediately after the surgery

    Proportion of patients who died within 30 days after surgery among participants

  2. 90-day mortality rate

    Time frame: Participants were followed up to 90 days immediately after the surgery

    Proportion of patients who died within 90 days after surgery among participants

  3. Incidence of postoperative complications

    Time frame: Participants were followed during hospitalization (up to 14 days)

    Proportion of patients who developed any complications during postoperative hospitalization among participants

Study contacts

Contact information is provided by the study sponsor or research team.

Eun young Kim

CONTACT

[email protected]

+82-10-4720-0246

Hye sung Kim

CONTACT

[email protected]

+82-10-6325-5910

Sponsors and collaborators

Lead sponsor

Seoul St. Mary's Hospital

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jun 13, 2024
Registry last updated
Jun 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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