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Predictive Value of Dynamic Combination of BNP and NGAL for the Prognosis of Patients With Sepsis

Primary Purpose

28-day Mortality, Sepsis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
BNP and NGAL
Sponsored by
Southeast University, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for 28-day Mortality focused on measuring BNP, NGAL, Sepsis, Mortality

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age ≥18 years and <85 years;
  • presence of severe sepsis according to Survival Sepsis Campaign 10;
  • all patients voluntarily joined this study with informed consents.

Exclusion Criteria:

  • participated in other trials within 30 days before the criteria for this trial were met;
  • expected to die within 24 hours;
  • pregnant;
  • advanced malignancy with life expectancy <6 months;
  • history of congestive heart failure;
  • chronic renal dysfunction (baseline creatinine >176.8μmol/L); and
  • relatives were unwilling to agree to the use of full life support.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Sham Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Low BNP and Low NGAL Group

    High BNP and Low NGAL Group

    Low BNP and High NGAL Group

    High BNP and High NGAL Group

    Arm Description

    BNP≤100pg/ml and NGAL≤153pg/ml

    BNP>100pg/ml and NGAL≤153pg/ml

    BNP≤100pg/ml and NGAL>153pg/ml

    BNP>100pg/ml and NGAL>153pg/ml

    Outcomes

    Primary Outcome Measures

    patient-ventilator synchrony for 30mins

    Secondary Outcome Measures

    the numbers of days in the ICU between day 1 and day 28
    Mechanical ventilation duration between day 1 and day 28
    28-day mortality

    Full Information

    First Posted
    July 25, 2016
    Last Updated
    August 17, 2016
    Sponsor
    Southeast University, China
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02871544
    Brief Title
    Predictive Value of Dynamic Combination of BNP and NGAL for the Prognosis of Patients With Sepsis
    Official Title
    Predictive Value of Dynamic Combination of B-type Natriuretic Peptide and Neutrophil Gelatinase-associated Lipocalin for the Prognosis of Patients With Sepsis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2015 (undefined)
    Primary Completion Date
    February 2016 (Actual)
    Study Completion Date
    February 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Southeast University, China

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Objective: to clarify the predictive value of brain natriuretic peptide (BNP) in combination with neutrophil gelatinase associated lipocalin (NGAL) for the prognosis of patients with sepsis.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    28-day Mortality, Sepsis
    Keywords
    BNP, NGAL, Sepsis, Mortality

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Factorial Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    124 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Low BNP and Low NGAL Group
    Arm Type
    Sham Comparator
    Arm Description
    BNP≤100pg/ml and NGAL≤153pg/ml
    Arm Title
    High BNP and Low NGAL Group
    Arm Type
    Active Comparator
    Arm Description
    BNP>100pg/ml and NGAL≤153pg/ml
    Arm Title
    Low BNP and High NGAL Group
    Arm Type
    Active Comparator
    Arm Description
    BNP≤100pg/ml and NGAL>153pg/ml
    Arm Title
    High BNP and High NGAL Group
    Arm Type
    Active Comparator
    Arm Description
    BNP>100pg/ml and NGAL>153pg/ml
    Intervention Type
    Other
    Intervention Name(s)
    BNP and NGAL
    Primary Outcome Measure Information:
    Title
    patient-ventilator synchrony for 30mins
    Time Frame
    30mins after the patients involved
    Secondary Outcome Measure Information:
    Title
    the numbers of days in the ICU between day 1 and day 28
    Time Frame
    the numbers of days in the ICU until day 28
    Title
    Mechanical ventilation duration between day 1 and day 28
    Time Frame
    days of mechanical ventilation between day 1 and day 28
    Title
    28-day mortality
    Time Frame
    28 days after the patients involved

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: age ≥18 years and <85 years; presence of severe sepsis according to Survival Sepsis Campaign 10; all patients voluntarily joined this study with informed consents. Exclusion Criteria: participated in other trials within 30 days before the criteria for this trial were met; expected to die within 24 hours; pregnant; advanced malignancy with life expectancy <6 months; history of congestive heart failure; chronic renal dysfunction (baseline creatinine >176.8μmol/L); and relatives were unwilling to agree to the use of full life support.

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Predictive Value of Dynamic Combination of BNP and NGAL for the Prognosis of Patients With Sepsis

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