Effect of Nutritional Support and Early Rehabilitation on Sepsis

Life Quality Clinical Trial

— NUSPOTER  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05781971
• Other study ID #: NUSPOTER
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2024
• Est. completion date: May 2026

Study information

• Verified date: June 2024
• Source: Jinling Hospital, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1600
• Est. completion date: May 2026
• Est. primary completion date: May 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Standard

1. Patients with sepsis

2. Patients aged 18-70 years

3. Time of admission =48 h

4. Non-terminal condition

Exclusion Standard

1. Severe acute kidney injury

2. Severe chronic liver disease (MELD score =20) or acute hepatic failure

3. Protein allergy

4. Pregnancy and lactation

5. BMI=30 kg/m²

Related Conditions & MeSH terms

• Hospital Mortality
• Life Quality

Intervention

Dietary Supplement:
• high protein
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.

Behavioral:
• rehabilitation
In this trial, the investigator will provide early rehabilitation treatment such as respiratory training, bicycle training, and medium frequency electrical stimulation to patients.

Dietary Supplement:
• standard protein
The investigator set a protein target of 1.2 g/Kg/d for the standard protein group, which will be supplied enterally or parenterally.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Jinling Hospital, China	The First Affiliated Hospital of Soochow University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital Mortality	Chart review	Day 90
Secondary	Nutrition related indicators	Chart review	Hospital discharge
Secondary	Physical functioning	Grip dynamometer	Hospital discharge
Secondary	Prognostic factor	Chart review	Hospital discharge
Secondary	Health-related quality of life	SF-36 and EQ-5D-5L	Day 90