Serial Body Composition Change for Risk Prediction and Nutritional Guide in Treating Patients With Sepsis

To explore whether serial changes of data in body composition of patients with sepsis can help clinician to monitor prognosis.

Study Overview

• Status: Completed
• Conditions: Sepsis
• Intervention / Treatment: Dietary supplement: Nutritional intervention

Detailed Description

The investigators will use the random number generator to divide the patients into two groups, the control group (with no nutritional intervention) and the intervention group (with nutritional intervention). The body composition data (of day 1, 3, 8) of the patients in the intervention group will be given to the dietitians for adjusting the diet formula according to the patient's body composition.The patients in control group also will undergo Bio-electrical Impedance Analysis (BIA) assessment, but not disclosed to the dietitian. The diet formula will be adjusted on the discretion of the dietitian caring for the septic patients based on clinical judgement.

• Study Type: Interventional
• Enrollment (Actual): 132
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: HUNG KAI-YIN; Phone Number: 8775 +886 7 731 7123; Email: redrosahung@cgmh.org.tw
• Study Contact Backup: Name: FANG WEN-FENG; Phone Number: 8775 +886 7 731 7123; Email: wenfengfang@yahoo.com.tw

Study Locations

• Taiwan
  • Kaohsiung City, Taiwan, 83301
    • Kaohsiung Chang Gung Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. ICU patient
2. Clinical diagnosis of sepsis

Exclusion Criteria:

1. Expired within 3-days

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control; The investigators will use the random number generator to divide the patients into two groups, the control group (with no nutritional intervention) and the intervention group (with nutritional intervention). The body composition data (of day 1, 3, 8) of the patients in the control group will not be given to the dietitians for adjusting the diet formula according to the patient's body composition.
Experimental: nutritional intervention; The investigators will use the random number generator to divide the patients into two groups, the control group (with no nutritional intervention) and the intervention group (with nutritional intervention). The body composition data (of day 1, 3, 8) of the patients in the intervention group will be given to the dietitians for adjusting the diet formula according to the patient's body composition.	Dietary supplement: Nutritional intervention; In the intervention group, the body composition data (of day 1, 3, 8) will be given to the dietitians for adjusting the diet formula. The diet formula will be adjusted on the discretion of the dietitian caring for the septic patients based on clinical judgement. The policy adopted by the dietary treatment guidelines for sepsis is to adjust the dietary concentration when there is too much extracellular water under the premise of gastrointestinal tolerance. When the skeletal muscle mass loss is too fast, the dietitians will increase the protein intake by 1.2g/kg of body weight. For patients with acute renal failure and excess extracellular water accumulation and muscle loss, the dietitians will adjust the protein, sodium, potassium, calcium and phosphorus content in the formula. The dietitians will give appropriate nutrition prescriptions based on clinical signs, disease diagnosis and biochemical values.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ICU mortality	Status of survival or mortality at the time discharged from ICU	The day discharged from ICU, an average of 2 weeks
Hospital mortality	Status of survival or mortality at the time discharged from hospital	The day discharged from hospital, an average of 5 weeks
7-day mortality	Status of survival or mortality at Day 7 during hospital stay	Day 7 after hospital admission
28-day mortality	Status of survival or mortality at Day 28 during hospital stay	Day 28 after hospital admission
90-day mortality	Status of survival or mortality at Day 90 during hospital stay	Day 90 after hospital admission

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of white blood cell between day 1 and day 3	assessing the change of white blood cell count between day 1 and day 3	Day 1 and Day 3 after ICU admission
Change of white blood cell between day 1 and day 8	assessing the change of white blood cell count between day 1 and day 8	Day 1 and Day8 after ICU admission
Change of white blood cell between day 3 and day 8	assessing the change of white blood cell count between day 3 and day 8	Day 3 and Day 8 after ICU admission
Change of pulse pressure between day 1 and day 3	assessing the change of pulse pressure between day 1 and day 3	Day 1 and Day 3 after ICU admission
Change of pulse pressure between day 1 and day 8	assessing the change of pulse pressure between day 1 and day 8	Day 1 and Day 8 after ICU admission
Change of pulse pressure between day 3 and day 8	assessing the change of pulse pressure between day 3 and day 8	Day 3 and Day 8 after ICU admission
Day 1 Sequential Organ Failure Assessment score	assessing Sequential Organ Failure Assessment score at day 1	Day 1 after ICU admission
Day 3 Sequential Organ Failure Assessment score	assessing Sequential Organ Failure Assessment score at day 3	Day 3 after ICU admission
Day 8 Sequential Organ Failure Assessment score	assessing Sequential Organ Failure Assessment score at day 8	Day 8 after ICU admission
Ventilation days	Total using days of mechanical ventilation	The day weaned off ventilator, an average of 3 weeks
Change of percentage of body fat between day 1 and day 3	assessing the change of percentage of body fat between day 1 and day 3	Day 1 and Day 3 after ICU admission
Change of percentage of body fat between day 1 and day 8	assessing the change of percentage of body fat between day 1 and day 8	Day 1 and Day 8 after ICU admission
Change of percentage of body fat between day 3 and day 8	assessing the change of percentage of body fat between day 3 and day 8	Day 3 and Day 8 after ICU admission
Change of protein intake between day 1 and day 3	assessing the change of protein intake (g/day, g/kg) between day 1 and day 3	Day 1 and Day 3 after ICU admission
Change of protein intake between day 1 and day 8	assessing the change of protein intake (g/day, g/kg) between day 1 and day 8	Day 1 and Day 8 after ICU admission
Change of protein intake between day 3 and day 8	assessing the change of protein intake (g/day, g/kg) between day 3 and day 8	Day 3 and Day 8 after ICU admission
Change of energy intake between day 1 and day 3	assessing the change of energy intake (total kcal/day) between day 1 and day 3	Day 1 and Day 3 after ICU admission
Change of energy intake between day 1 and day 8	assessing the change of energy intake (total kcal/day) between day 1 and day 8	Day 1 and Day 8 after ICU admission
Change of energy intake between day 3 and day 8	assessing the change of energy intake (total kcal/day) between day 3 and day 8	Day 3 and Day 8 after ICU admission
Change of segment/monocyte ratio between day 1 and day 3	assessing the change of segment count to monocyte count ratio between day 1 and day 3	Day 1 and Day 3 after ICU admission
Change of segment/monocyte ratio between day 1 and day 8	assessing the change of segment count to monocyte count ratio between day 1 and day 8	Day 1 and Day 8 after ICU admission
Change of segment/monocyte ratio between day 3 and day 8	assessing the change of segment count to monocyte count ratio between day 3 and day 8	Day 3 and Day 8 after ICU admission
Change of total body water between day 1 and day 3	assessing the change of total body water between day 1 and day 3	Day 1 and Day 3 after ICU admission
Change of total body water between day 1 and day 8	assessing the change of total body water between day 1 and day 8	Day 1 and Day 8 after ICU admission
Change of total body water between day 3 and day 8	assessing the change of total body water between day 3 and day 8	Day 3 and Day 8 after ICU admission
Change of soft lean mass between day 1 and day 3	assessing the change of soft lean mass between day 1 and day 3	Day 1 and Day 3 after ICU admission
Change of soft lean mass between day 1 and day 8	assessing the change of soft lean mass between day 1 and day 8	Day 1 and Day 8 after ICU admission
Change of soft lean mass between day 3 and day 8	assessing the change of soft lean mass between day 3 and day 8	Day 3 and Day 8 after ICU admission
ICU Days	length of ICU stay	The day discharged from ICU, an average of 2 weeks

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Investigators: Study Director: FANG WEN-FENG, Chang Gung memorial hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Actual): March 19, 2023
• Study Completion (Actual): April 28, 2023

Study Registration Dates

• First Submitted: July 1, 2021
• First Submitted That Met QC Criteria: July 29, 2021
• First Posted (Actual): August 4, 2021

Study Record Updates

• Last Update Posted (Actual): September 1, 2023
• Last Update Submitted That Met QC Criteria: August 31, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: sepsis; body composition; Nutritional intervention
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia
• Other Study ID Numbers: 201901875A3C501

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No