Clinical trial NCT04989569: Serial Body Composition Change for Risk Prediction and Nutritional Guide in Treating Patients With Sepsis
Official title: Serial Body Composition Change for Risk Prediction and Nutritional Guide in Treating Patients With Sepsis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sepsis
Keywords: sepsis
body composition
Nutritional intervention
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2021-08-04
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

1. ICU patient
2. Clinical diagnosis of sepsis

Exclusion Criteria:

1. Expired within 3-days

Primary outcomes:
measure: ICU mortality
timeFrame: The day discharged from ICU, an average of 2 weeks
measure: Hospital mortality
timeFrame: The day discharged from hospital, an average of 5 weeks
measure: 7-day mortality
timeFrame: Day 7 after hospital admission
measure: 28-day mortality
timeFrame: Day 28 after hospital admission
measure: 90-day mortality
timeFrame: Day 90 after hospital admission
Secondary outcomes:
measure: Change of white blood cell between day 1 and day 3
timeFrame: Day 1 and Day 3 after ICU admission
measure: Change of white blood cell between day 1 and day 8
timeFrame: Day 1 and Day8 after ICU admission
measure: Change of white blood cell between day 3 and day 8
timeFrame: Day 3 and Day 8 after ICU admission
measure: Change of pulse pressure between day 1 and day 3
timeFrame: Day 1 and Day 3 after ICU admission
measure: Change of pulse pressure between day 1 and day 8
timeFrame: Day 1 and Day 8 after ICU admission
measure: Change of pulse pressure between day 3 and day 8
timeFrame: Day 3 and Day 8 after ICU admission
measure: Day 1 Sequential Organ Failure Assessment score
timeFrame: Day 1 after ICU admission
measure: Day 3 Sequential Organ Failure Assessment score
timeFrame: Day 3 after ICU admission
measure: Day 8 Sequential Organ Failure Assessment score
timeFrame: Day 8 after ICU admission
measure: Ventilation days
timeFrame: The day weaned off ventilator, an average of 3 weeks
measure: Change of percentage of body fat between day 1 and day 3
timeFrame: Day 1 and Day 3 after ICU admission
measure: Change of percentage of body fat between day 1 and day 8
timeFrame: Day 1 and Day 8 after ICU admission
measure: Change of percentage of body fat between day 3 and day 8
timeFrame: Day 3 and Day 8 after ICU admission
measure: Change of protein intake between day 1 and day 3
timeFrame: Day 1 and Day 3 after ICU admission
measure: Change of protein intake between day 1 and day 8
timeFrame: Day 1 and Day 8 after ICU admission
measure: Change of protein intake between day 3 and day 8
timeFrame: Day 3 and Day 8 after ICU admission
measure: Change of energy intake between day 1 and day 3
timeFrame: Day 1 and Day 3 after ICU admission
measure: Change of energy intake between day 1 and day 8
timeFrame: Day 1 and Day 8 after ICU admission
measure: Change of energy intake between day 3 and day 8
timeFrame: Day 3 and Day 8 after ICU admission
measure: Change of segment/monocyte ratio between day 1 and day 3
timeFrame: Day 1 and Day 3 after ICU admission
measure: Change of segment/monocyte ratio between day 1 and day 8
timeFrame: Day 1 and Day 8 after ICU admission
measure: Change of segment/monocyte ratio between day 3 and day 8
timeFrame: Day 3 and Day 8 after ICU admission
measure: Change of total body water between day 1 and day 3
timeFrame: Day 1 and Day 3 after ICU admission
measure: Change of total body water between day 1 and day 8
timeFrame: Day 1 and Day 8 after ICU admission
measure: Change of total body water between day 3 and day 8
timeFrame: Day 3 and Day 8 after ICU admission
measure: Change of soft lean mass between day 1 and day 3
timeFrame: Day 1 and Day 3 after ICU admission
measure: Change of soft lean mass between day 1 and day 8
timeFrame: Day 1 and Day 8 after ICU admission
measure: Change of soft lean mass between day 3 and day 8
timeFrame: Day 3 and Day 8 after ICU admission
measure: ICU Days
timeFrame: The day discharged from ICU, an average of 2 weeks
Other outcomes:
Locations:
city: Kaohsiung City
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: FANG WEN-FENG
role: STUDY_DIRECTOR
References: