NCT04989569

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P50-P75 for not_applicable sepsis

Timeline
Completed

Started Aug 2020

Typical duration for not_applicable sepsis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2020

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 1, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 4, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 19, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 28, 2023

Completed
Last Updated

September 1, 2023

Status Verified

August 1, 2023

Enrollment Period

2.6 years

First QC Date

July 1, 2021

Last Update Submit

August 31, 2023

Conditions

Sepsis

Keywords

sepsisbody compositionNutritional intervention

Outcome Measures

Primary Outcomes (5)

  • ICU mortality

    Status of survival or mortality at the time discharged from ICU

    The day discharged from ICU, an average of 2 weeks

  • Hospital mortality

    Status of survival or mortality at the time discharged from hospital

    The day discharged from hospital, an average of 5 weeks

  • 7-day mortality

    Status of survival or mortality at Day 7 during hospital stay

    Day 7 after hospital admission

  • 28-day mortality

    Status of survival or mortality at Day 28 during hospital stay

    Day 28 after hospital admission

  • 90-day mortality

    Status of survival or mortality at Day 90 during hospital stay

    Day 90 after hospital admission

Secondary Outcomes (29)

  • Change of white blood cell 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

    Day 1 and Day8 after ICU admission

  • Change of white blood cell between day 3 and day 8

    Day 3 and Day 8 after ICU admission

  • 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

    Day 1 and Day 8 after ICU admission

  • +24 more secondary outcomes

Study Arms (2)

control

NO 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 control group will not be given to the dietitians for adjusting the diet formula according to the patient's body composition.

nutritional intervention

EXPERIMENTAL

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

Interventions

Nutritional interventionDIETARY_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.

nutritional intervention

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ICU patient
  • Clinical diagnosis of sepsis

You may not qualify if:

  • \. Expired within 3-days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 83301, Taiwan

Location

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • FANG WEN-FENG

    Chang Gung Memorial Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2021

First Posted

August 4, 2021

Study Start

August 1, 2020

Primary Completion

March 19, 2023

Study Completion

April 28, 2023

Last Updated

September 1, 2023

Record last verified: 2023-08

Locations

TW(1)