Life QualityNUSPOTERNCT05781971
Effect of Nutritional Support and Early Rehabilitation on Sepsis
A study testing high protein, rehabilitation and standard protein in people with Life Quality and Hospital Mortality, run by Jinling Hospital, China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Life Quality, Hospital Mortality
- What is being tested?
- high protein, rehabilitation and standard protein
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,600 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2024to May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with sepsis
- Patients aged 18-70 years
- Time of admission ≤48 h
- Non-terminal condition
Who cannot join
- Severe acute kidney injury
- Severe chronic liver disease (MELD score ≥20) or acute hepatic failure
- Protein allergy
- Pregnancy and lactation
- BMI≥30 kg/m²
About this study
Official title: Department of Intensive Care Medicine, The First Affiliated Hospital of Soochow University
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.
Read the 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
- Being tested
- high protein, rehabilitation, standard protein
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high proteinDietary 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.
rehabilitationBehavioural
In this trial, the investigator will provide early rehabilitation treatment such as respiratory training, bicycle training, and medium frequency electrical stimulation to patients.
standard proteinDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| high protein + early bedside rehabilitation | Experimental | Not described Receives: Dietary Supplement: high protein; Behavioral: rehabilitation |
| high protein alone | Active comparator | Not described Receives: Dietary Supplement: high protein |
| standard protein + early bedside | Placebo comparator | standard protein and rehabilitation Receives: Behavioral: rehabilitation; Dietary Supplement: standard protein |
| standard protein | Sham comparator | only standard protein Receives: Dietary Supplement: standard protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Mortality
Chart review
Measured: Day 90
Secondary outcomes (4)
Nutrition related indicators
Chart review
Measured: Hospital discharge
Physical functioning
Grip dynamometer
Measured: Hospital discharge
Prognostic factor
Chart review
Measured: Hospital discharge
Health-related quality of life
SF-36 and EQ-5D-5L
Measured: Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2023
- Study start1 Dec 2024 (estimated)
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Life QualityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 1,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jinling Hospital, China
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Soochow University
- Responsible party
- Principal investigator, Yao Wei,MD, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05781971
- Sponsor's protocol ID
- NUSPOTER
- Acronym
- NUSPOTER
- Status last verified
- Jun 2024
- First submitted
- 1 Feb 2023
- Last updated
- 17 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Department of Intensive Care Medicine, The First Affiliated Hospital of Soochow University
- ClinicalTrials.gov ID
- NCT05781971
- Acronym / sponsor ID
- NUSPOTER / NUSPOTER
- Conditions
- Life Quality, Hospital Mortality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- Jinling Hospital, ChinaUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Soochow University
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 23 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: rehabilitation, Dietary Supplement: standard proteinstandard protein and rehabilitation |
| standard protein | Sham comparator | Dietary Supplement: standard proteinonly standard protein |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with sepsis
- Patients aged 18-70 years
- Time of admission ≤48 h
- Non-terminal condition
Key exclusion criteria (5 listed)
- Severe acute kidney injury
- Severe chronic liver disease (MELD score ≥20) or acute hepatic failure
- Protein allergy
- Pregnancy and lactation
- BMI≥30 kg/m²
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| high proteinPatients 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. | Dietary supplement | high protein + early bedside rehabilitation, high protein alone |
| rehabilitationIn this trial, the investigator will provide early rehabilitation treatment such as respiratory training, bicycle training, and medium frequency electrical stimulation to patients. | Behavioural | high protein + early bedside rehabilitation, standard protein + early bedside |
| standard proteinThe investigator set a protein target of 1.2 g/Kg/d for the standard protein group, which will be supplied enterally or parenterally. | Dietary supplement | standard protein, standard protein + early bedside |
Primary outcome
Hospital Mortality
Time frame: Day 90
Chart review
4 secondary outcomes
Nutrition related indicators
Time frame: Hospital discharge
Physical functioning
Time frame: Hospital discharge
Prognostic factor
Time frame: Hospital discharge
Health-related quality of life
Time frame: Day 90
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing high protein, rehabilitation and standard protein in people with Life Quality and Hospital Mortality, run by Jinling Hospital, China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital Mortality (time frame: Day 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2024.