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
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Seoul St. Mary's Hospital |
Korea, Republic of,
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) |
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