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Effect of Nutritional Support and Early Rehabilitation on Sepsis

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05781971
Acronym
NUSPOTER
Enrollment
1600
Registered
2023-03-23
Start date
2024-12-01
Completion date
2026-05-31
Last updated
2024-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Life Quality, Hospital Mortality

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.

Interventions

DIETARY_SUPPLEMENThigh 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.

BEHAVIORALrehabilitation

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

DIETARY_SUPPLEMENTstandard 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.

Sponsors

The First Affiliated Hospital of Soochow University
CollaboratorOTHER
Jinling Hospital, China
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Hospital MortalityDay 90Chart review

Secondary

MeasureTime frameDescription
Nutrition related indicatorsHospital dischargeChart review
Physical functioningHospital dischargeGrip dynamometer
Prognostic factorHospital dischargeChart review
Health-related quality of lifeDay 90SF-36 and EQ-5D-5L

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026