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

Primary Purpose

Protein-Energy Malnutrition

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Active nutritional supplementation
Conventional nutritional supplementation
Sponsored by
Seoul St. Mary's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Protein-Energy Malnutrition

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Active nutritional supplementation

Conventional nutritional supplementation

Arm Description

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.

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

Outcomes

Primary Outcome Measures

60-day mortality rate
Proportion of patients who died within 60 days after surgery among participants

Secondary Outcome Measures

In-hospital mortality rate
Proportion of patients who died during the hospitalization period
Incidence of postoperative complications
Proportion of patients who died within 60 days after surgery among participants

Full Information

First Posted
September 5, 2023
Last Updated
September 25, 2023
Sponsor
Seoul St. Mary's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06058247
Brief Title
Reducing In-Hospital and 60-Day Mortality in ICU Patients After Surgery With Strict Nutritional Supplementation
Official Title
Reducing In-Hospital and 60-Day Mortality in Critically Ill Patients After Surgery With Strict Nutritional Supplementation: A Prospective, Single-Labeled, Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
August 1, 2022 (Actual)
Study Completion Date
August 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul St. Mary's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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 nutritional therapy 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 or calorie intake vary according to different guidelines, and this is the same for surgical patients. Additionally, some patients experience a delay in initiating nutritional support, and several studies reported that only 39 - 63% of the intended energy and 45 - 55% of the prescribed protein are being administered to critically ill patients during the acute phase. Furthermore, recent randomized controlled trials reported conflicting results with current guidelines, with some suggesting that lower calorie or higher protein dose administrations did not significantly impact clinical outcomes and may even worsen the outcomes for certain patient groups. Thus, the optimal nutritional provision target during the acute phase of critical illness, particularly for surgical patients, remains controversial, and there is no standardized protocol. In our previous study, the malnutrition status upon admission, indicated by a modified Nutrition Risk in the Critically Ill (mNUTRIC) score of 5 or higher, and low energy adequacy during intensive care unit (ICU) stay were identified as mortality predictors in critically ill patients following abdominal surgery. 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. Additionally, the investigators investigated the appropriate target for nutrition support in critically ill patients who undergo abdominal surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Protein-Energy Malnutrition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
368 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active nutritional supplementation
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional nutritional supplementation
Arm Type
Experimental
Arm Description
The participants in conventional nutritional supplementation arm underwent conventional nutrition management without specific protein or caloric targets.
Intervention Type
Dietary Supplement
Intervention Name(s)
Active nutritional supplementation
Intervention Description
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%.
Intervention Type
Dietary Supplement
Intervention Name(s)
Conventional nutritional supplementation
Intervention Description
The participants in conventional nutritional supplementation arm received conservative nutritional management without specific protein or caloric targets.
Primary Outcome Measure Information:
Title
60-day mortality rate
Description
Proportion of patients who died within 60 days after surgery among participants
Time Frame
Participants were followed upto 60th day after surgery
Secondary Outcome Measure Information:
Title
In-hospital mortality rate
Description
Proportion of patients who died during the hospitalization period
Time Frame
Participants were followed upto 60th day after surgery
Title
Incidence of postoperative complications
Description
Proportion of patients who died within 60 days after surgery among participants
Time Frame
Participants were followed upto 60th day after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hye sung Kim
Organizational Affiliation
The Catholic University of Korea
Official's Role
Study Director
Facility Information:
Facility Name
Division of Trauma and Surgical Critical Care, Department of Surgery, Seoul St. Mary's Hospital
City
Seoul
State/Province
Seocho-gu, Banpo-dong Banpodaero 222
ZIP/Postal Code
137-701
Country
Korea, Republic of

12. IPD Sharing Statement

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

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