Effect of Nutritional Support and Early Rehabilitation on Sepsis

NCT ID: NCT05781971

Last Updated: 2024-06-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-01
• Study Completion Date: 2026-05-31

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.

Conditions

Life Quality; Hospital Mortality

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

high protein + early bedside rehabilitation

Group Type: EXPERIMENTAL

high protein

Intervention Type: DIETARY_SUPPLEMENT

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.

rehabilitation

Intervention Type: BEHAVIORAL

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

high protein alone

Group Type: ACTIVE_COMPARATOR

high protein

Intervention Type: DIETARY_SUPPLEMENT

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.

standard protein + early bedside

standard protein and rehabilitation

Group Type: PLACEBO_COMPARATOR

rehabilitation

Intervention Type: BEHAVIORAL

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

standard protein

Intervention Type: DIETARY_SUPPLEMENT

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

standard protein

only standard protein

Group Type: SHAM_COMPARATOR

standard protein

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

rehabilitation

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

Intervention Type: BEHAVIORAL

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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital of Soochow University

OTHER

Sponsor Role: collaborator

Jinling Hospital, China

OTHER

Sponsor Role: lead

Responsible Party

Yao Wei,MD

associate chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

NUSPOTER

Identifier Type: -

Identifier Source: org_study_id