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NCT04989569 Clinical Trial

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

Sepsis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04989569
Other study ID # 201901875A3C501
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 1, 2020
Est. completion date April 28, 2023

Study information
Verified date August 2023
Source Chang Gung Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To explore whether serial changes of data in body composition of patients with sepsis can help clinician to monitor prognosis.

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 information / eligibility
Status Completed
Enrollment 132
Est. completion date April 28, 2023
Est. primary completion date March 19, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: 1. ICU patient 2. Clinical diagnosis of sepsis Exclusion Criteria: 1. Expired within 3-days

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Taiwan Kaohsiung Chang Gung Memorial Hospital Kaohsiung City

Sponsors (1)
Lead Sponsor Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary ICU mortality Status of survival or mortality at the time discharged from ICU The day discharged from ICU, an average of 2 weeks
Primary Hospital mortality Status of survival or mortality at the time discharged from hospital The day discharged from hospital, an average of 5 weeks
Primary 7-day mortality Status of survival or mortality at Day 7 during hospital stay Day 7 after hospital admission
Primary 28-day mortality Status of survival or mortality at Day 28 during hospital stay Day 28 after hospital admission
Primary 90-day mortality Status of survival or mortality at Day 90 during hospital stay Day 90 after hospital admission
Secondary 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 Day 1 and Day 3 after ICU admission
Secondary 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 Day 1 and Day8 after ICU admission
Secondary 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 Day 3 and Day 8 after ICU admission
Secondary Change of pulse pressure between day 1 and day 3 assessing the change of pulse pressure between day 1 and day 3 Day 1 and Day 3 after ICU admission
Secondary Change of pulse pressure between day 1 and day 8 assessing the change of pulse pressure between day 1 and day 8 Day 1 and Day 8 after ICU admission
Secondary Change of pulse pressure between day 3 and day 8 assessing the change of pulse pressure between day 3 and day 8 Day 3 and Day 8 after ICU admission
Secondary Day 1 Sequential Organ Failure Assessment score assessing Sequential Organ Failure Assessment score at day 1 Day 1 after ICU admission
Secondary Day 3 Sequential Organ Failure Assessment score assessing Sequential Organ Failure Assessment score at day 3 Day 3 after ICU admission
Secondary Day 8 Sequential Organ Failure Assessment score assessing Sequential Organ Failure Assessment score at day 8 Day 8 after ICU admission
Secondary Ventilation days Total using days of mechanical ventilation The day weaned off ventilator, an average of 3 weeks
Secondary 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 Day 1 and Day 3 after ICU admission
Secondary 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 Day 1 and Day 8 after ICU admission
Secondary 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 Day 3 and Day 8 after ICU admission
Secondary 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 Day 1 and Day 3 after ICU admission
Secondary 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 Day 1 and Day 8 after ICU admission
Secondary 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 Day 3 and Day 8 after ICU admission
Secondary 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 Day 1 and Day 3 after ICU admission
Secondary 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 Day 1 and Day 8 after ICU admission
Secondary 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 Day 3 and Day 8 after ICU admission
Secondary 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 Day 1 and Day 3 after ICU admission
Secondary 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 Day 1 and Day 8 after ICU admission
Secondary 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 Day 3 and Day 8 after ICU admission
Secondary Change of total body water between day 1 and day 3 assessing the change of total body water between day 1 and day 3 Day 1 and Day 3 after ICU admission
Secondary Change of total body water between day 1 and day 8 assessing the change of total body water between day 1 and day 8 Day 1 and Day 8 after ICU admission
Secondary Change of total body water between day 3 and day 8 assessing the change of total body water between day 3 and day 8 Day 3 and Day 8 after ICU admission
Secondary Change of soft lean mass between day 1 and day 3 assessing the change of soft lean mass between day 1 and day 3 Day 1 and Day 3 after ICU admission
Secondary Change of soft lean mass between day 1 and day 8 assessing the change of soft lean mass between day 1 and day 8 Day 1 and Day 8 after ICU admission
Secondary Change of soft lean mass between day 3 and day 8 assessing the change of soft lean mass between day 3 and day 8 Day 3 and Day 8 after ICU admission
Secondary ICU Days length of ICU stay The day discharged from ICU, an average of 2 weeks
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