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

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

Detailed Description
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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.

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

Conditions
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Sepsis

Intervention / Treatment
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* Dietary Supplement: Nutritional intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ICU patient Clinical diagnosis of sepsis Exclusion Criteria: 1. Expired within 3-days

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control<br>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<br>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<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sepsis, body composition, Nutritional intervention