Reducing In-Hospital and 60-Day Mortality in ICU Patients After Surgery With Strict Nutritional Supplementation

NCT06058247 | Completed

• 1 other identifier: NUMIS_02
• Study Type: interventional
• Target: 368
• Locations: 1 country
• Sites: 1

Brief Summary

Malnutrition in critically ill patients is a global concern due to its association with increased infectious complications, 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, guidelines remain broad, and practical implementation is often inadequate. The investigators aimed to assess the effects of strict nutritional provision, targeting an energy adequacy of 80% or more and a protein intake of at least 1.5 g/kg/day, on in-hospital and 60-day mortality.

Conditions

Protein-Energy Malnutrition

Outcome Measures

Primary Outcomes (1)

• 60-day mortality rate

  Proportion of patients who died within 60 days after surgery among participants

  Participants were followed upto 60th day after surgery

Secondary Outcomes (2)

• In-hospital mortality rate

  Participants were followed upto 60th day after surgery

• Incidence of postoperative complications

  Participants were followed upto 60th day after surgery

Study Arms (2)

Active nutritional supplementation

EXPERIMENTAL

The participants in active nutritional supplementation arm received nutritional support targeting specific protein (over 1.5 g/kg/day) and calorie intake (over 20 kcal/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 nutritional supplementation

Conventional nutritional supplementation

EXPERIMENTAL

The participants in conventional nutritional supplementation arm underwent conventional nutrition management without specific protein or caloric targets.

Dietary Supplement: Conventional nutritional supplementation

Interventions

Active nutritional 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 nutritional supplementation arm were protein supplementation at over 1.5 g/kg/day, calorie provision at over 20 kcal/kg/day, and energy adequacy of at least 80%. Energy target was estimated by multiplying the resting energy expenditure using the Harris and Benedict equation by an activity factor of 1.3 and a stress factor of 1.1. 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 nutritional supplementation

Conventional nutritional supplementation DIETARY_SUPPLEMENT

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

Conventional nutritional 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
• diagnosed with renal failure and receiving renal replacement therapy
• lacked individual data necessary to calculate the mNUTRIC score measured at ICU admission
• failed to provide informed consent, or with 'do-not-resuscitate' status.
• the patient was discharged or expired within 48 hours of ICU admission
• patients diagnosed with multiorgan failure, represented by a high Sequential Organ Failure Assessment (SOFA) score (≥9) upon ICU admission

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

Protein-Energy Malnutrition

Condition Hierarchy (Ancestors)

Protein Deficiency; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Hye sung Kim

  The Catholic University of Korea

  STUDY DIRECTOR

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: September 5, 2023
• First Posted: September 28, 2023
• Study Start: March 1, 2019
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: September 28, 2023

Record last verified: 2023-09

Locations

KR (1)