Serial Body Composition Change for Risk Prediction and Nutritional Guide in Treating Patients With Sepsis
- Conditions
- Sepsis
- Interventions
- Dietary Supplement: Nutritional intervention
- Registration Number
- NCT04989569
- Lead Sponsor
- Chang Gung Memorial Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 132
- ICU patient
- Clinical diagnosis of sepsis
- Expired within 3-days
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description nutritional intervention 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.
- Primary Outcome Measures
Name Time Method Hospital mortality The day discharged from hospital, an average of 5 weeks Status of survival or mortality at the time discharged from hospital
90-day mortality Day 90 after hospital admission Status of survival or mortality at Day 90 during hospital stay
7-day mortality Day 7 after hospital admission Status of survival or mortality at Day 7 during hospital stay
ICU mortality The day discharged from ICU, an average of 2 weeks Status of survival or mortality at the time discharged from ICU
28-day mortality Day 28 after hospital admission Status of survival or mortality at Day 28 during hospital stay
- Secondary Outcome Measures
Name Time Method ICU Days The day discharged from ICU, an average of 2 weeks length of ICU stay
Change of white blood cell between day 1 and day 3 Day 1 and Day 3 after ICU admission assessing the change of white blood cell count between day 1 and day 3
Change of percentage of body fat between day 1 and day 8 Day 1 and Day 8 after ICU admission assessing the change of percentage of body fat between day 1 and day 8
Change of protein intake between day 1 and day 3 Day 1 and Day 3 after ICU admission assessing the change of protein intake (g/day, g/kg) between day 1 and day 3
Change of energy intake between day 1 and day 3 Day 1 and Day 3 after ICU admission assessing the change of energy intake (total kcal/day) between day 1 and day 3
Change of energy intake between day 1 and day 8 Day 1 and Day 8 after ICU admission assessing the change of energy intake (total kcal/day) between day 1 and day 8
Change of total body water between day 1 and day 3 Day 1 and Day 3 after ICU admission assessing the change of total body water between day 1 and day 3
Change of pulse pressure between day 1 and day 3 Day 1 and Day 3 after ICU admission assessing the change of pulse pressure between day 1 and day 3
Change of pulse pressure between day 3 and day 8 Day 3 and Day 8 after ICU admission assessing the change of pulse pressure between day 3 and day 8
Ventilation days The day weaned off ventilator, an average of 3 weeks Total using days of mechanical ventilation
Change of protein intake between day 3 and day 8 Day 3 and Day 8 after ICU admission assessing the change of protein intake (g/day, g/kg) between day 3 and day 8
Change of segment/monocyte ratio between day 1 and day 3 Day 1 and Day 3 after ICU admission assessing the change of segment count to monocyte count ratio between day 1 and day 3
Change of white blood cell between day 1 and day 8 Day 1 and Day8 after ICU admission assessing the change of white blood cell count between day 1 and day 8
Change of pulse pressure between day 1 and day 8 Day 1 and Day 8 after ICU admission assessing the change of pulse pressure between day 1 and day 8
Day 1 Sequential Organ Failure Assessment score Day 1 after ICU admission assessing Sequential Organ Failure Assessment score at day 1
Day 8 Sequential Organ Failure Assessment score Day 8 after ICU admission assessing Sequential Organ Failure Assessment score at day 8
Change of percentage of body fat between day 1 and day 3 Day 1 and Day 3 after ICU admission assessing the change of percentage of body fat between day 1 and day 3
Change of protein intake between day 1 and day 8 Day 1 and Day 8 after ICU admission assessing the change of protein intake (g/day, g/kg) between day 1 and day 8
Change of white blood cell between day 3 and day 8 Day 3 and Day 8 after ICU admission assessing the change of white blood cell count between day 3 and day 8
Change of energy intake between day 3 and day 8 Day 3 and Day 8 after ICU admission assessing the change of energy intake (total kcal/day) between day 3 and day 8
Change of soft lean mass between day 1 and day 8 Day 1 and Day 8 after ICU admission assessing the change of soft lean mass between day 1 and day 8
Day 3 Sequential Organ Failure Assessment score Day 3 after ICU admission assessing Sequential Organ Failure Assessment score at day 3
Change of percentage of body fat between day 3 and day 8 Day 3 and Day 8 after ICU admission assessing the change of percentage of body fat between day 3 and day 8
Change of segment/monocyte ratio between day 1 and day 8 Day 1 and Day 8 after ICU admission assessing the change of segment count to monocyte count ratio between day 1 and day 8
Change of total body water between day 1 and day 8 Day 1 and Day 8 after ICU admission assessing the change of total body water between day 1 and day 8
Change of segment/monocyte ratio between day 3 and day 8 Day 3 and Day 8 after ICU admission assessing the change of segment count to monocyte count ratio between day 3 and day 8
Change of total body water between day 3 and day 8 Day 3 and Day 8 after ICU admission assessing the change of total body water between day 3 and day 8
Change of soft lean mass between day 1 and day 3 Day 1 and Day 3 after ICU admission assessing the change of soft lean mass between day 1 and day 3
Change of soft lean mass between day 3 and day 8 Day 3 and Day 8 after ICU admission assessing the change of soft lean mass between day 3 and day 8
Trial Locations
- Locations (1)
Kaohsiung Chang Gung Memorial Hospital
🇨🇳Kaohsiung City, Taiwan