Effect of Nutritional Support and Early Rehabilitation on Sepsis

NCT05781971 | Not Yet Recruiting

• 1 other identifier: NUSPOTER
• Study Type: interventional
• Target: 1,600
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Life Quality; Hospital Mortality

Outcome Measures

Primary Outcomes (1)

• Hospital Mortality

  Chart review

  Day 90

Secondary Outcomes (4)

• Nutrition related indicators

  Hospital discharge

• Physical functioning

  Hospital discharge

• Prognostic factor

  Hospital discharge

• Health-related quality of life

  Day 90

Study Arms (4)

high protein + early bedside rehabilitation

EXPERIMENTAL

Dietary Supplement: high protein; Behavioral: rehabilitation

high protein alone

ACTIVE COMPARATOR

Dietary Supplement: high protein

standard protein + early bedside

PLACEBO COMPARATOR

standard protein and rehabilitation

Behavioral: rehabilitation; Dietary Supplement: standard protein

standard protein

SHAM COMPARATOR

only standard protein

Dietary Supplement: standard protein

Interventions

high protein 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.

high protein + early bedside rehabilitation; high protein alone

rehabilitation 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 + early bedside rehabilitation; standard protein + early bedside

standard protein 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; standard protein + early bedside

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Jinling Hospital, China: lead
• The First Affiliated Hospital of Soochow University: collaborator

MeSH Terms

Interventions

Rehabilitation

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate chief physician

Study Record Dates

• First Submitted: February 1, 2023
• First Posted: March 23, 2023
• Study Start: December 1, 2024
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: June 17, 2024

Record last verified: 2024-06