Effect of Nutritional Support and Early Rehabilitation on Sepsis

Not Applicable

Not yet recruiting

• Conditions: Life Quality; Hospital Mortality
• Interventions: Behavioral: rehabilitation; Dietary Supplement: high protein; Dietary Supplement: standard protein

• Registration Number: NCT05781971
• Lead Sponsor: Jinling Hospital, China

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.

Study Timeline

• Study First Submitted: 2023-02-01
• Study First Submitted QC: 2023-03-12
• Study First Posted: 2023-03-23
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-14
• Last Update Posted: 2024-06-17
• Study Start: 2024-12-01
• Primary Completion: 2026-05
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1600

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard protein + early bedside	rehabilitation	standard protein and rehabilitation
high protein + early bedside rehabilitation	high protein	-
high protein alone	high protein	-
standard protein + early bedside	standard protein	standard protein and rehabilitation
standard protein	standard protein	only standard protein
high protein + early bedside rehabilitation	rehabilitation	-

Primary Outcome Measures

Name	Time	Method
Hospital Mortality	Day 90	Chart review

Secondary Outcome Measures

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