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

Primary Purpose

Sepsis

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Nutritional intervention
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Sepsis focused on measuring sepsis, body composition, Nutritional intervention

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. ICU patient
  2. Clinical diagnosis of sepsis

Exclusion Criteria:

1. Expired within 3-days

Sites / Locations

  • Kaohsiung Chang Gung Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

control

nutritional intervention

Arm 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 control group will not be given to the dietitians for adjusting the diet formula according to the patient's body composition.

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.

Outcomes

Primary Outcome Measures

ICU mortality
Status of survival or mortality at the time discharged from ICU
Hospital mortality
Status of survival or mortality at the time discharged from hospital
7-day mortality
Status of survival or mortality at Day 7 during hospital stay
28-day mortality
Status of survival or mortality at Day 28 during hospital stay
90-day mortality
Status of survival or mortality at Day 90 during hospital stay

Secondary Outcome Measures

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
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
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
Change of pulse pressure between day 1 and day 3
assessing the change of pulse pressure between day 1 and day 3
Change of pulse pressure between day 1 and day 8
assessing the change of pulse pressure between day 1 and day 8
Change of pulse pressure between day 3 and day 8
assessing the change of pulse pressure between day 3 and day 8
Day 1 Sequential Organ Failure Assessment score
assessing Sequential Organ Failure Assessment score at day 1
Day 3 Sequential Organ Failure Assessment score
assessing Sequential Organ Failure Assessment score at day 3
Day 8 Sequential Organ Failure Assessment score
assessing Sequential Organ Failure Assessment score at day 8
Ventilation days
Total using days of mechanical ventilation
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
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
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
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
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
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
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
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
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
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
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
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
Change of total body water between day 1 and day 3
assessing the change of total body water between day 1 and day 3
Change of total body water between day 1 and day 8
assessing the change of total body water between day 1 and day 8
Change of total body water between day 3 and day 8
assessing the change of total body water between day 3 and day 8
Change of soft lean mass between day 1 and day 3
assessing the change of soft lean mass between day 1 and day 3
Change of soft lean mass between day 1 and day 8
assessing the change of soft lean mass between day 1 and day 8
Change of soft lean mass between day 3 and day 8
assessing the change of soft lean mass between day 3 and day 8
ICU Days
length of ICU stay

Full Information

First Posted
July 1, 2021
Last Updated
August 31, 2023
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04989569
Brief Title
Serial Body Composition Change for Risk Prediction and Nutritional Guide in Treating Patients With Sepsis
Official Title
Serial Body Composition Change for Risk Prediction and Nutritional Guide in Treating Patients With Sepsis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
March 19, 2023 (Actual)
Study Completion Date
April 28, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

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

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis
Keywords
sepsis, body composition, Nutritional intervention

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
132 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control
Arm Type
No Intervention
Arm 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 control group will not be given to the dietitians for adjusting the diet formula according to the patient's body composition.
Arm Title
nutritional intervention
Arm Type
Experimental
Arm 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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Nutritional intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
ICU mortality
Description
Status of survival or mortality at the time discharged from ICU
Time Frame
The day discharged from ICU, an average of 2 weeks
Title
Hospital mortality
Description
Status of survival or mortality at the time discharged from hospital
Time Frame
The day discharged from hospital, an average of 5 weeks
Title
7-day mortality
Description
Status of survival or mortality at Day 7 during hospital stay
Time Frame
Day 7 after hospital admission
Title
28-day mortality
Description
Status of survival or mortality at Day 28 during hospital stay
Time Frame
Day 28 after hospital admission
Title
90-day mortality
Description
Status of survival or mortality at Day 90 during hospital stay
Time Frame
Day 90 after hospital admission
Secondary Outcome Measure Information:
Title
Change of white blood cell between day 1 and day 3
Description
assessing the change of white blood cell count between day 1 and day 3
Time Frame
Day 1 and Day 3 after ICU admission
Title
Change of white blood cell between day 1 and day 8
Description
assessing the change of white blood cell count between day 1 and day 8
Time Frame
Day 1 and Day8 after ICU admission
Title
Change of white blood cell between day 3 and day 8
Description
assessing the change of white blood cell count between day 3 and day 8
Time Frame
Day 3 and Day 8 after ICU admission
Title
Change of pulse pressure between day 1 and day 3
Description
assessing the change of pulse pressure between day 1 and day 3
Time Frame
Day 1 and Day 3 after ICU admission
Title
Change of pulse pressure between day 1 and day 8
Description
assessing the change of pulse pressure between day 1 and day 8
Time Frame
Day 1 and Day 8 after ICU admission
Title
Change of pulse pressure between day 3 and day 8
Description
assessing the change of pulse pressure between day 3 and day 8
Time Frame
Day 3 and Day 8 after ICU admission
Title
Day 1 Sequential Organ Failure Assessment score
Description
assessing Sequential Organ Failure Assessment score at day 1
Time Frame
Day 1 after ICU admission
Title
Day 3 Sequential Organ Failure Assessment score
Description
assessing Sequential Organ Failure Assessment score at day 3
Time Frame
Day 3 after ICU admission
Title
Day 8 Sequential Organ Failure Assessment score
Description
assessing Sequential Organ Failure Assessment score at day 8
Time Frame
Day 8 after ICU admission
Title
Ventilation days
Description
Total using days of mechanical ventilation
Time Frame
The day weaned off ventilator, an average of 3 weeks
Title
Change of percentage of body fat between day 1 and day 3
Description
assessing the change of percentage of body fat between day 1 and day 3
Time Frame
Day 1 and Day 3 after ICU admission
Title
Change of percentage of body fat between day 1 and day 8
Description
assessing the change of percentage of body fat between day 1 and day 8
Time Frame
Day 1 and Day 8 after ICU admission
Title
Change of percentage of body fat between day 3 and day 8
Description
assessing the change of percentage of body fat between day 3 and day 8
Time Frame
Day 3 and Day 8 after ICU admission
Title
Change of protein intake between day 1 and day 3
Description
assessing the change of protein intake (g/day, g/kg) between day 1 and day 3
Time Frame
Day 1 and Day 3 after ICU admission
Title
Change of protein intake between day 1 and day 8
Description
assessing the change of protein intake (g/day, g/kg) between day 1 and day 8
Time Frame
Day 1 and Day 8 after ICU admission
Title
Change of protein intake between day 3 and day 8
Description
assessing the change of protein intake (g/day, g/kg) between day 3 and day 8
Time Frame
Day 3 and Day 8 after ICU admission
Title
Change of energy intake between day 1 and day 3
Description
assessing the change of energy intake (total kcal/day) between day 1 and day 3
Time Frame
Day 1 and Day 3 after ICU admission
Title
Change of energy intake between day 1 and day 8
Description
assessing the change of energy intake (total kcal/day) between day 1 and day 8
Time Frame
Day 1 and Day 8 after ICU admission
Title
Change of energy intake between day 3 and day 8
Description
assessing the change of energy intake (total kcal/day) between day 3 and day 8
Time Frame
Day 3 and Day 8 after ICU admission
Title
Change of segment/monocyte ratio between day 1 and day 3
Description
assessing the change of segment count to monocyte count ratio between day 1 and day 3
Time Frame
Day 1 and Day 3 after ICU admission
Title
Change of segment/monocyte ratio between day 1 and day 8
Description
assessing the change of segment count to monocyte count ratio between day 1 and day 8
Time Frame
Day 1 and Day 8 after ICU admission
Title
Change of segment/monocyte ratio between day 3 and day 8
Description
assessing the change of segment count to monocyte count ratio between day 3 and day 8
Time Frame
Day 3 and Day 8 after ICU admission
Title
Change of total body water between day 1 and day 3
Description
assessing the change of total body water between day 1 and day 3
Time Frame
Day 1 and Day 3 after ICU admission
Title
Change of total body water between day 1 and day 8
Description
assessing the change of total body water between day 1 and day 8
Time Frame
Day 1 and Day 8 after ICU admission
Title
Change of total body water between day 3 and day 8
Description
assessing the change of total body water between day 3 and day 8
Time Frame
Day 3 and Day 8 after ICU admission
Title
Change of soft lean mass between day 1 and day 3
Description
assessing the change of soft lean mass between day 1 and day 3
Time Frame
Day 1 and Day 3 after ICU admission
Title
Change of soft lean mass between day 1 and day 8
Description
assessing the change of soft lean mass between day 1 and day 8
Time Frame
Day 1 and Day 8 after ICU admission
Title
Change of soft lean mass between day 3 and day 8
Description
assessing the change of soft lean mass between day 3 and day 8
Time Frame
Day 3 and Day 8 after ICU admission
Title
ICU Days
Description
length of ICU stay
Time Frame
The day discharged from ICU, an average of 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ICU patient Clinical diagnosis of sepsis Exclusion Criteria: 1. Expired within 3-days
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
FANG WEN-FENG
Organizational Affiliation
Chang Gung Memorial Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Kaohsiung Chang Gung Memorial Hospital
City
Kaohsiung City
ZIP/Postal Code
83301
Country
Taiwan

12. IPD Sharing Statement

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

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