Department of Intensive Care Medicine, The First Affiliated Hospital of Soochow University
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 1,600
- Primary Endpoint
- Hospital Mortality
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Inclusion Standard
- •Patients with sepsis
- •Patients aged 18-70 years
- •Time of admission ≤48 h
- •Non-terminal condition
- •Exclusion Standard
- •Severe acute kidney injury
- •Severe chronic liver disease (MELD score ≥20) or acute hepatic failure
- •Protein allergy
- •Pregnancy and lactation
- •BMI≥30 kg/m²
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Hospital Mortality
Time Frame: Day 90
Chart review
Secondary Outcomes
- Prognostic factor(Hospital discharge)
- Physical functioning(Hospital discharge)
- Health-related quality of life(Day 90)
- Nutrition related indicators(Hospital discharge)
Investigators
Yao Wei,MD
associate chief physician
The First Affiliated Hospital of Soochow University