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Effect of Nutritional Support and Early Rehabilitation on Sepsis

ConditionsLife QualityHospital Mortality
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorJinling Hospital, China

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with sepsis

Patients aged 18-70 years

Time of admission ≤48 h

Non-terminal condition

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

  • 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.

Treatment groups

1,600 Participants
are divided into 4 treatment groups
Group A: high protein + early bedside rehabilitationExperimental treatment 2 interventions
Group B: high protein aloneActive comparator 1 intervention
Group C: standard protein + early bedsidePlacebo comparator 2 interventions
Group D: standard proteinSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Hospital Mortality

Chart review

Time frame
Day 90

Secondary outcomes

1

Nutrition related indicators

Chart review

Time frame
Hospital discharge
2

Physical functioning

Grip dynamometer

Time frame
Hospital discharge
3

Prognostic factor

Chart review

Time frame
Hospital discharge
4

Health-related quality of life

SF-36 and EQ-5D-5L

Time frame
Day 90

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jinling Hospital, China

Lead sponsor

The First Affiliated Hospital of Soochow University

Sponsor institution

The First Affiliated Hospital of Soochow University

Collaborator

Source ClinicalTrials.gov

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