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

ConditionProtein Malnutrition
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSeoul St. Mary's Hospital

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

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

Disqualifiers

aged under 18 years

underwent surgery under local or regional anesthesia

pregnant

readmitted to the ICU due to any cause

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

152 Participants
are divided into 2 treatment groups
Group A: Active protein supplementationExperimental treatment 1 intervention
Group B: Conventional protein supplementationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

6-month mortality rate

Proportion of patients who died within 6 months after surgery among participants

Time frame
Participants were followed up to 180 days immediately after the surgery

Secondary outcomes

1

30-day mortality rate

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

Time frame
Participants were followed up to 30 days immediately after the surgery
2

90-day mortality rate

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

Time frame
Participants were followed up to 90 days immediately after the surgery
3

Incidence of postoperative complications

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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Seoul St. Mary's Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: