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

August 17, 2016 updated by: Chun Pan, Southeast University, China

Predictive Value of Dynamic Combination of B-type Natriuretic Peptide and Neutrophil Gelatinase-associated Lipocalin for the Prognosis of Patients With Sepsis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

124

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Low BNP and Low NGAL Group
BNP≤100pg/ml and NGAL≤153pg/ml
Other: BNP and NGAL
Active Comparator: High BNP and Low NGAL Group
BNP>100pg/ml and NGAL≤153pg/ml
Other: BNP and NGAL
Active Comparator: Low BNP and High NGAL Group
BNP≤100pg/ml and NGAL>153pg/ml
Other: BNP and NGAL
Active Comparator: High BNP and High NGAL Group
BNP>100pg/ml and NGAL>153pg/ml
Other: BNP and NGAL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
patient-ventilator synchrony for 30mins
Time Frame: 30mins after the patients involved
30mins after the patients involved

Secondary Outcome Measures

Outcome Measure
Time Frame
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
the numbers of days in the ICU until day 28
Mechanical ventilation duration between day 1 and day 28
Time Frame: days of mechanical ventilation between day 1 and day 28
days of mechanical ventilation between day 1 and day 28
28-day mortality
Time Frame: 28 days after the patients involved
28 days after the patients involved

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southeast University, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

July 25, 2016

First Submitted That Met QC Criteria

August 17, 2016

First Posted (Estimate)

August 18, 2016

Study Record Updates

Last Update Posted (Estimate)

August 18, 2016

Last Update Submitted That Met QC Criteria

August 17, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Zhongda Hospital AKI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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