Serial Body Composition Change for Risk Prediction and Nutritional Guide in Treating Patients With Sepsis

August 31, 2023 updated by: Chang Gung Memorial Hospital
To explore whether serial changes of data in body composition of patients with sepsis can help clinician to monitor prognosis.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
132

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Taiwan
      • Kaohsiung City, Taiwan, 83301
        • Kaohsiung Chang Gung Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. ICU patient
  2. Clinical diagnosis of sepsis

Exclusion Criteria:

1. Expired within 3-days

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: control
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.
Experimental: nutritional 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 intervention group will be given to the dietitians for adjusting the diet formula according to the patient's body composition.
Dietary supplement: Nutritional intervention
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
The day discharged from ICU, an average of 2 weeks
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
The day discharged from hospital, an average of 5 weeks
7-day mortality
Time Frame: Day 7 after hospital admission
Status of survival or mortality at Day 7 during hospital stay
Day 7 after hospital admission
28-day mortality
Time Frame: Day 28 after hospital admission
Status of survival or mortality at Day 28 during hospital stay
Day 28 after hospital admission
90-day mortality
Time Frame: Day 90 after hospital admission
Status of survival or mortality at Day 90 during hospital stay
Day 90 after hospital admission

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change of white blood cell between day 1 and day 3
Time Frame: Day 1 and Day 3 after ICU admission
assessing the change of white blood cell count between day 1 and day 3
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
assessing the change of white blood cell count between day 1 and day 8
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
assessing the change of white blood cell count between day 3 and day 8
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
assessing the change of pulse pressure between day 1 and day 3
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
assessing the change of pulse pressure between day 1 and day 8
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
assessing the change of pulse pressure between day 3 and day 8
Day 3 and Day 8 after ICU admission
Day 1 Sequential Organ Failure Assessment score
Time Frame: Day 1 after ICU admission
assessing Sequential Organ Failure Assessment score at day 1
Day 1 after ICU admission
Day 3 Sequential Organ Failure Assessment score
Time Frame: Day 3 after ICU admission
assessing Sequential Organ Failure Assessment score at day 3
Day 3 after ICU admission
Day 8 Sequential Organ Failure Assessment score
Time Frame: Day 8 after ICU admission
assessing Sequential Organ Failure Assessment score at day 8
Day 8 after ICU admission
Ventilation days
Time Frame: The day weaned off ventilator, an average of 3 weeks
Total using days of mechanical ventilation
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
assessing the change of percentage of body fat between day 1 and day 3
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
assessing the change of percentage of body fat between day 1 and day 8
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
assessing the change of percentage of body fat between day 3 and day 8
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
assessing the change of protein intake (g/day, g/kg) between day 1 and day 3
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
assessing the change of protein intake (g/day, g/kg) between day 1 and day 8
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
assessing the change of protein intake (g/day, g/kg) between day 3 and day 8
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
assessing the change of energy intake (total kcal/day) between day 1 and day 3
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
assessing the change of energy intake (total kcal/day) between day 1 and day 8
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
assessing the change of energy intake (total kcal/day) between day 3 and day 8
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
assessing the change of segment count to monocyte count ratio between day 1 and day 3
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
assessing the change of segment count to monocyte count ratio between day 1 and day 8
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
assessing the change of segment count to monocyte count ratio between day 3 and day 8
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
assessing the change of total body water between day 1 and day 3
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
assessing the change of total body water between day 1 and day 8
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
assessing the change of total body water between day 3 and day 8
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
assessing the change of soft lean mass between day 1 and day 3
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
assessing the change of soft lean mass between day 1 and day 8
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
assessing the change of soft lean mass between day 3 and day 8
Day 3 and Day 8 after ICU admission
ICU Days
Time Frame: The day discharged from ICU, an average of 2 weeks
length of ICU stay
The day discharged from ICU, an average of 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chang Gung Memorial Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: FANG WEN-FENG, Chang Gung Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 19, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 28, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 1, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 29, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 4, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 1, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 201901875A3C501

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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