SepsisNCT04989569
Serial Body Composition Change for Risk Prediction and Nutritional Guide in Treating Patients With Sepsis
A study testing Nutritional intervention in people with Sepsis, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
To explore whether serial changes of data in body composition of patients with sepsis can help clinician to monitor prognosis. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Sepsis
- What is being tested?
- Nutritional intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2020to 28 Apr 2023
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ICU patient
- Clinical diagnosis of sepsis
Who cannot join
- 1. Expired within 3-days
Trial locations and contacts
1 site in 1 country.
About this study
To explore whether serial changes of data in body composition of patients with sepsis can help clinician to monitor prognosis.
Read the detailed description
The investigators will use the random number generator to divide the patients into two groups, the control group (with no nutritional intervention) and the intervention group (with nutritional intervention). The body composition data (of day 1, 3, 8) of the patients in the intervention group will be given to the dietitians for adjusting the diet formula according to the patient's body composition.The patients in control group also will undergo Bio-electrical Impedance Analysis (BIA) assessment, but not disclosed to the dietitian. The diet formula will be adjusted on the discretion of the dietitian caring for the septic patients based on clinical judgement.
- Conditions
- Sepsis
- Being tested
- Nutritional intervention
- Keywords
- sepsis, body composition, Nutritional intervention
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional interventionDietary supplement
In the intervention group, the body composition data (of day 1, 3, 8) will be given to the dietitians for adjusting the diet formula. The diet formula will be adjusted on the discretion of the dietitian caring for the septic patients based on clinical judgement. The policy adopted by the dietary treatment guidelines for sepsis is to adjust the dietary concentration when there is too much extracellular water under the premise of gastrointestinal tolerance. When the skeletal muscle mass loss is too fast, the dietitians will increase the protein intake by 1.2g/kg of body weight. For patients with acute renal failure and excess extracellular water accumulation and muscle loss, the dietitians will adjust the protein, sodium, potassium, calcium and phosphorus content in the formula. The dietitians will give appropriate nutrition prescriptions based on clinical signs, disease diagnosis and biochemical values.
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | The investigators will use the random number generator to divide the patients into two groups, the control group (with no nutritional intervention) and the intervention group (with nutritional intervention). The body composition data (of day 1, 3, 8) of the patients in the control group will not be given to the dietitians for adjusting the diet formula according to the patient's body composition. |
| nutritional intervention | Experimental | The investigators will use the random number generator to divide the patients into two groups, the control group (with no nutritional intervention) and the intervention group (with nutritional intervention). The body composition data (of day 1, 3, 8) of the patients in the intervention group will be given to the dietitians for adjusting the diet formula according to the patient's body composition. Receives: Dietary Supplement: Nutritional intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU mortality
Status of survival or mortality at the time discharged from ICU
Measured: The day discharged from ICU, an average of 2 weeks
Hospital mortality
Status of survival or mortality at the time discharged from hospital
Measured: The day discharged from hospital, an average of 5 weeks
7-day mortality
Status of survival or mortality at Day 7 during hospital stay
Measured: Day 7 after hospital admission
28-day mortality
Status of survival or mortality at Day 28 during hospital stay
Measured: Day 28 after hospital admission
90-day mortality
Status of survival or mortality at Day 90 during hospital stay
Measured: Day 90 after hospital admission
Secondary outcomes (29)
Change of white blood cell between day 1 and day 3
assessing the change of white blood cell count between day 1 and day 3
Measured: Day 1 and Day 3 after ICU admission
Change of white blood cell between day 1 and day 8
assessing the change of white blood cell count between day 1 and day 8
Measured: Day 1 and Day8 after ICU admission
Change of white blood cell between day 3 and day 8
assessing the change of white blood cell count between day 3 and day 8
Measured: Day 3 and Day 8 after ICU admission
Change of pulse pressure between day 1 and day 3
assessing the change of pulse pressure between day 1 and day 3
Measured: Day 1 and Day 3 after ICU admission
Change of pulse pressure between day 1 and day 8
assessing the change of pulse pressure between day 1 and day 8
Measured: Day 1 and Day 8 after ICU admission
Change of pulse pressure between day 3 and day 8
assessing the change of pulse pressure between day 3 and day 8
Measured: Day 3 and Day 8 after ICU admission
Day 1 Sequential Organ Failure Assessment score
assessing Sequential Organ Failure Assessment score at day 1
Measured: Day 1 after ICU admission
Day 3 Sequential Organ Failure Assessment score
assessing Sequential Organ Failure Assessment score at day 3
Measured: Day 3 after ICU admission
Day 8 Sequential Organ Failure Assessment score
assessing Sequential Organ Failure Assessment score at day 8
Measured: Day 8 after ICU admission
Ventilation days
Total using days of mechanical ventilation
Measured: The day weaned off ventilator, an average of 3 weeks
Change of percentage of body fat between day 1 and day 3
assessing the change of percentage of body fat between day 1 and day 3
Measured: Day 1 and Day 3 after ICU admission
Change of percentage of body fat between day 1 and day 8
assessing the change of percentage of body fat between day 1 and day 8
Measured: Day 1 and Day 8 after ICU admission
Change of percentage of body fat between day 3 and day 8
assessing the change of percentage of body fat between day 3 and day 8
Measured: Day 3 and Day 8 after ICU admission
Change of protein intake between day 1 and day 3
assessing the change of protein intake (g/day, g/kg) between day 1 and day 3
Measured: Day 1 and Day 3 after ICU admission
Change of protein intake between day 1 and day 8
assessing the change of protein intake (g/day, g/kg) between day 1 and day 8
Measured: Day 1 and Day 8 after ICU admission
Change of protein intake between day 3 and day 8
assessing the change of protein intake (g/day, g/kg) between day 3 and day 8
Measured: Day 3 and Day 8 after ICU admission
Change of energy intake between day 1 and day 3
assessing the change of energy intake (total kcal/day) between day 1 and day 3
Measured: Day 1 and Day 3 after ICU admission
Change of energy intake between day 1 and day 8
assessing the change of energy intake (total kcal/day) between day 1 and day 8
Measured: Day 1 and Day 8 after ICU admission
Change of energy intake between day 3 and day 8
assessing the change of energy intake (total kcal/day) between day 3 and day 8
Measured: Day 3 and Day 8 after ICU admission
Change of segment/monocyte ratio between day 1 and day 3
assessing the change of segment count to monocyte count ratio between day 1 and day 3
Measured: Day 1 and Day 3 after ICU admission
Change of segment/monocyte ratio between day 1 and day 8
assessing the change of segment count to monocyte count ratio between day 1 and day 8
Measured: Day 1 and Day 8 after ICU admission
Change of segment/monocyte ratio between day 3 and day 8
assessing the change of segment count to monocyte count ratio between day 3 and day 8
Measured: Day 3 and Day 8 after ICU admission
Change of total body water between day 1 and day 3
assessing the change of total body water between day 1 and day 3
Measured: Day 1 and Day 3 after ICU admission
Change of total body water between day 1 and day 8
assessing the change of total body water between day 1 and day 8
Measured: Day 1 and Day 8 after ICU admission
Change of total body water between day 3 and day 8
assessing the change of total body water between day 3 and day 8
Measured: Day 3 and Day 8 after ICU admission
Change of soft lean mass between day 1 and day 3
assessing the change of soft lean mass between day 1 and day 3
Measured: Day 1 and Day 3 after ICU admission
Change of soft lean mass between day 1 and day 8
assessing the change of soft lean mass between day 1 and day 8
Measured: Day 1 and Day 8 after ICU admission
Change of soft lean mass between day 3 and day 8
assessing the change of soft lean mass between day 3 and day 8
Measured: Day 3 and Day 8 after ICU admission
ICU Days
length of ICU stay
Measured: The day discharged from ICU, an average of 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2021
- Study start1 Aug 2020
- Primary completion19 Mar 2023
- Study completion28 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- FANG WEN-FENG, Study director, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04989569
- Sponsor's protocol ID
- 201901875A3C501
- Status last verified
- Aug 2023
- First submitted
- 1 Jul 2021
- Last updated
- 1 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serial Body Composition Change for Risk Prediction and Nutritional Guide in Treating Patients With Sepsis
- ClinicalTrials.gov ID
- NCT04989569
- Acronym / sponsor ID
- 201901875A3C501
- Conditions
- Sepsis
- Keywords
- sepsis, body composition, Nutritional intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 19 Mar 2023 (actual)
- Study completion
- 28 Apr 2023 (actual)
- First posted
- 4 Aug 2021 (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.
To explore whether serial changes of data in body composition of patients with sepsis can help clinician to monitor prognosis.
Detailed description
The investigators will use the random number generator to divide the patients into two groups, the control group (with no nutritional intervention) and the intervention group (with nutritional intervention). The body composition data (of day 1, 3, 8) of the patients in the intervention group will be given to the dietitians for adjusting the diet formula according to the patient's body composition.The patients in control group also will undergo Bio-electrical Impedance Analysis (BIA) assessment, but not disclosed to the dietitian. The diet formula will be adjusted on the discretion of the dietitian caring for the septic patients based on clinical judgement.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –The investigators will use the random number generator to divide the patients into two groups, the control group (with no nutritional intervention) and the intervention group (with nutritional intervention). The body composition data (of day 1, 3, 8) of the patients in the control group will not be given to the dietitians for adjusting the diet formula according to the patient's body composition. |
| nutritional intervention | Experimental | Dietary Supplement: Nutritional interventionThe investigators will use the random number generator to divide the patients into two groups, the control group (with no nutritional intervention) and the intervention group (with nutritional intervention). The body composition data (of day 1, 3, 8) of the patients in the intervention group will be given to the dietitians for adjusting the diet formula according to the patient's body composition. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ICU patient
- Clinical diagnosis of sepsis
Key exclusion criteria (1 listed)
- 1. Expired within 3-days
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 |
|---|---|---|
| Nutritional interventionIn the intervention group, the body composition data (of day 1, 3, 8) will be given to the dietitians for adjusting the diet formula. The diet formula will be adjusted on the discretion of the dietitian caring for the septic patients based on clinical judgement. The policy adopted by the dietary treatment guidelines for sepsis is to adjust the dietary concentration when there is too much extracellular water under the premise of gastrointestinal tolerance. When the skeletal muscle mass loss is too fast, the dietitians will increase the protein intake by 1.2g/kg of body weight. For patients with acute renal failure and excess extracellular water accumulation and muscle loss, the dietitians will adjust the protein, sodium, potassium, calcium and phosphorus content in the formula. The dietitians will give appropriate nutrition prescriptions based on clinical signs, disease diagnosis and biochemical values. | Dietary supplement | nutritional intervention |
Primary outcome
ICU mortality
Time frame: The day discharged from ICU, an average of 2 weeks
Status of survival or mortality at the time discharged from ICU
Hospital mortality
Time frame: The day discharged from hospital, an average of 5 weeks
Status of survival or mortality at the time discharged from hospital
7-day mortality
Time frame: Day 7 after hospital admission
Status of survival or mortality at Day 7 during hospital stay
28-day mortality
Time frame: Day 28 after hospital admission
Status of survival or mortality at Day 28 during hospital stay
90-day mortality
Time frame: Day 90 after hospital admission
Status of survival or mortality at Day 90 during hospital stay
29 secondary outcomes
Change of white blood cell between day 1 and day 3
Time frame: Day 1 and Day 3 after ICU admission
Change of white blood cell between day 1 and day 8
Time frame: Day 1 and Day8 after ICU admission
Change of white blood cell between day 3 and day 8
Time frame: Day 3 and Day 8 after ICU admission
Change of pulse pressure between day 1 and day 3
Time frame: Day 1 and Day 3 after ICU admission
Change of pulse pressure between day 1 and day 8
Time frame: Day 1 and Day 8 after ICU admission
Change of pulse pressure between day 3 and day 8
Time frame: Day 3 and Day 8 after ICU admission
Day 1 Sequential Organ Failure Assessment score
Time frame: Day 1 after ICU admission
Day 3 Sequential Organ Failure Assessment score
Time frame: Day 3 after ICU admission
Day 8 Sequential Organ Failure Assessment score
Time frame: Day 8 after ICU admission
Ventilation days
Time frame: The day weaned off ventilator, an average of 3 weeks
Change of percentage of body fat between day 1 and day 3
Time frame: Day 1 and Day 3 after ICU admission
Change of percentage of body fat between day 1 and day 8
Time frame: Day 1 and Day 8 after ICU admission
Change of percentage of body fat between day 3 and day 8
Time frame: Day 3 and Day 8 after ICU admission
Change of protein intake between day 1 and day 3
Time frame: Day 1 and Day 3 after ICU admission
Change of protein intake between day 1 and day 8
Time frame: Day 1 and Day 8 after ICU admission
Change of protein intake between day 3 and day 8
Time frame: Day 3 and Day 8 after ICU admission
Change of energy intake between day 1 and day 3
Time frame: Day 1 and Day 3 after ICU admission
Change of energy intake between day 1 and day 8
Time frame: Day 1 and Day 8 after ICU admission
Change of energy intake between day 3 and day 8
Time frame: Day 3 and Day 8 after ICU admission
Change of segment/monocyte ratio between day 1 and day 3
Time frame: Day 1 and Day 3 after ICU admission
Change of segment/monocyte ratio between day 1 and day 8
Time frame: Day 1 and Day 8 after ICU admission
Change of segment/monocyte ratio between day 3 and day 8
Time frame: Day 3 and Day 8 after ICU admission
Change of total body water between day 1 and day 3
Time frame: Day 1 and Day 3 after ICU admission
Change of total body water between day 1 and day 8
Time frame: Day 1 and Day 8 after ICU admission
Change of total body water between day 3 and day 8
Time frame: Day 3 and Day 8 after ICU admission
Change of soft lean mass between day 1 and day 3
Time frame: Day 1 and Day 3 after ICU admission
Change of soft lean mass between day 1 and day 8
Time frame: Day 1 and Day 8 after ICU admission
Change of soft lean mass between day 3 and day 8
Time frame: Day 3 and Day 8 after ICU admission
ICU Days
Time frame: The day discharged from ICU, an average of 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2023.
Related trials for Sepsis
RecruitingPhase 2
Combination Cefazolin With Ertapenem for Methicillin-susceptible Staphylococcus Aureus Bacteremia
Staphylococcus Aureus Bacteremia, Staphylococcus Aureus Septicemia
Not yet recruiting
Personalized Metabolic Nutrition Sepsis Study
Pediatric Sepsis
RecruitingObservational study
Immunothrombosis With Septic Shock Undergoing Renal Replacement Therapy With the OXIRIS Membrane
Sepsis
RecruitingObservational study
Middle East Study of Infections in Patients With Hematological Malignancies
Hematological Malignancy, Hematopoetic Stem Cell Transplantation
RecruitingPhase 3
A Trial of Adjunctive Fludrocortisone (50mcg, 100mcg or Placebo) in Critically Ill Patients With Septic Shock Receiving Hydrocortisone, Evaluating Survival and Functional Recovery and the Influence of Transcriptomic Response
Septic Shock
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.
FANG WEN-FENG study director
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional intervention in people with Sepsis, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 1 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
ICU mortality (time frame: The day discharged from ICU, an average of 2 weeks). The study lists 5 primary outcomes in all. 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 1 Sep 2023.