Effect of Nutritional Support and Early Rehabilitation on Sepsis (NUSPOTER)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Life Quality; Hospital Mortality
• Intervention / Treatment: Dietary supplement: high protein; Behavioral: rehabilitation; Dietary supplement: standard protein

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 Type: Interventional
• Enrollment (Estimated): 1600
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: high protein + early bedside rehabilitation	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.
Active Comparator: high protein alone	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.
Placebo Comparator: standard protein + early bedside; standard protein and rehabilitation	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.
Sham Comparator: standard protein; only standard protein	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital Mortality	Chart review	Day 90

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nutrition related indicators	Chart review	Hospital discharge
Physical functioning	Grip dynamometer	Hospital discharge
Prognostic factor	Chart review	Hospital discharge
Health-related quality of life	SF-36 and EQ-5D-5L	Day 90

Collaborators and Investigators

• Sponsor: Jinling Hospital, China
• Collaborators: The First Affiliated Hospital of Soochow University

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2024
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: February 1, 2023
• First Submitted That Met QC Criteria: March 12, 2023
• First Posted (Actual): March 23, 2023

Study Record Updates

• Last Update Posted (Actual): June 17, 2024
• Last Update Submitted That Met QC Criteria: June 14, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: NUSPOTER

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No