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

Jinling Hospital, China

Status: Not yet enrolling

Conditions: Life Quality; Hospital Mortality

Treatments: Dietary Supplement: high protein; Behavioral: rehabilitation; Dietary Supplement: standard protein

Study type: Interventional

Funder types: Other

Identifiers

NCT05781971

NUSPOTER

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,600 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

1,600 participants in 4 patient groups, including a placebo group

high protein + early bedside rehabilitation

Experimental group

Treatment:

Behavioral: rehabilitation

Dietary Supplement: high protein

high protein alone

Active Comparator group

Treatment:

Dietary Supplement: high protein

standard protein + early bedside

Placebo Comparator group

Description:

standard protein and rehabilitation

Treatment:

Dietary Supplement: standard protein

Behavioral: rehabilitation

standard protein

Sham Comparator group

Description:

only standard protein

Treatment:

Dietary Supplement: standard protein