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

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02871544
• Other study ID #: Zhongda Hospital AKI
• Status: Completed
• Phase: N/A
• First received: July 25, 2016
• Last updated: August 17, 2016
• Start date: June 2015
• Est. completion date: February 2016

Study information

• Verified date: August 2016
• Source: Southeast University, China
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Jiangsu Province Health Department
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• 28-day Mortality
• Sepsis
• Toxemia

Intervention

Other:
• BNP and NGAL

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Southeast University, China

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	patient-ventilator synchrony for 30mins		30mins after the patients involved	No
Secondary	the numbers of days in the ICU between day 1 and day 28		the numbers of days in the ICU until day 28	No
Secondary	Mechanical ventilation duration between day 1 and day 28		days of mechanical ventilation between day 1 and day 28	No
Secondary	28-day mortality		28 days after the patients involved	No