Effect of Nutritional Support and Early Rehabilitation on Sepsis

Study Overview
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Brief Summary
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Sepsis is a syndrome of life-threatening organ dysfunction caused by a dysregulated host response to infection.Acute catabolic response in critically ill patients struck by sepsis, manifested by massive protein breakdown in a short time.This pathology frequently leads to prolonged hospitalization and mechanical ventilation, increased mortality, and reduced quality of survival.It is uncertainty whether sepsis patients in ICU can benefit from high protein intake combined with early exercise. Even though the combination has been shown to be beneficial in other populations.In the present study, the investigator will evaluate the effects of a combination of high protein targets combined with early rehabilitation in sepsis patients in ICU.

Detailed Description
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Existing research results confirm that high target protein support can reduce the mortality of sepsis patients. Early bedside rehabilitation has a good effect on cognitive function after ICU. This study combined high-protein nutritional support with bedside rehabilitation to improve the quality of life in patients with sepsis after ICU.

Official Title
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Department of Intensive Care Medicine, The First Affiliated Hospital of Soochow University

Conditions
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Life Quality, Hospital Mortality

Intervention / Treatment
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* Dietary Supplement: high protein
* Behavioral: rehabilitation
* Dietary Supplement: standard protein


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sepsis patients newly admitted to the ICU ICU stay is expected to last at least 7 days Age ≥18 years ,≤80 years old, and informed consent Non-terminal stage Exclusion Criteria: Patients with severe acute kidney injury pregnancy Allergic to protein Severe liver function related diseases (such as hepatic encephalopathy)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: high protein + early bedside rehabilitation<br> | Dietary Supplement: high protein<br>* Patients in high-protein group will be given a target protein amount of 2.0 g/kg/d. Standard enteral nutrition is the first choice,the remaining target value will be met by intravenous amino acid infusion.<br>Behavioral: rehabilitation<br>* In this trial, the investigator will provide early rehabilitation treatment such as respiratory training, bicycle training, and medium frequency electrical stimulation to patients.<br>|
| Active Comparator: high protein alone<br> | Dietary Supplement: high protein<br>* Patients in high-protein group will be given a target protein amount of 2.0 g/kg/d. Standard enteral nutrition is the first choice,the remaining target value will be met by intravenous amino acid infusion.<br>|
| Placebo Comparator: standard protein + early bedside<br>standard protein and rehabilitation | Behavioral: rehabilitation<br>* In this trial, the investigator will provide early rehabilitation treatment such as respiratory training, bicycle training, and medium frequency electrical stimulation to patients.<br>Dietary Supplement: standard protein<br>* The investigator set a protein target of 1.2 g/Kg/d for the standard protein group, which will be supplied enterally or parenterally.<br>|
| Sham Comparator: standard protein<br>only standard protein | Dietary Supplement: standard protein<br>* The investigator set a protein target of 1.2 g/Kg/d for the standard protein group, which will be supplied enterally or parenterally.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital Mortality |  | Day 28 | 
| Life quality | Health Questionnaire (EQ-5D-5L) | Day 60 |