Skip to main content
OpenTrials
Completed

NCT Number: NCT04989569

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sepsis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Systemic Inflammatory Response Syndrome

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 83301, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ICU patient
  • Clinical diagnosis of sepsis

Exclusion criteria

  • Expired within 3-days

Treatment and study plan

Nutritional intervention

Dietary 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.

Primary outcomes

  1. 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

  2. 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

  3. 7-day mortality

    Time frame: Day 7 after hospital admission

    Status of survival or mortality at Day 7 during hospital stay

  4. 28-day mortality

    Time frame: Day 28 after hospital admission

    Status of survival or mortality at Day 28 during hospital stay

  5. 90-day mortality

    Time frame: Day 90 after hospital admission

    Status of survival or mortality at Day 90 during hospital stay

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. Day 1 Sequential Organ Failure Assessment score

    Time frame: Day 1 after ICU admission

    assessing Sequential Organ Failure Assessment score at day 1

  8. Day 3 Sequential Organ Failure Assessment score

    Time frame: Day 3 after ICU admission

    assessing Sequential Organ Failure Assessment score at day 3

  9. Day 8 Sequential Organ Failure Assessment score

    Time frame: Day 8 after ICU admission

    assessing Sequential Organ Failure Assessment score at day 8

  10. Ventilation days

    Time frame: The day weaned off ventilator, an average of 3 weeks

    Total using days of mechanical ventilation

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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

  24. 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

  25. 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

  26. 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

  27. 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

  28. 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

  29. ICU Days

    Time frame: The day discharged from ICU, an average of 2 weeks

    length of ICU stay

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Aug 4, 2021
Registry last updated
Sep 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.