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

Not Applicable

Completed

• Conditions: 28-day Mortality; Sepsis
• Interventions: Other: BNP and NGAL

• Registration Number: NCT02871544
• Lead Sponsor: Southeast University, China

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Study First Submitted: 2016-07-25
• Status Verified: 2016-08
• Study First Submitted QC: 2016-08-17
• Last Update Submitted: 2016-08-17
• Study First Posted: 2016-08-18
• Last Update Posted: 2016-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

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

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Low BNP and High NGAL Group	BNP and NGAL	BNP≤100pg/ml and NGAL\>153pg/ml
Low BNP and Low NGAL Group	BNP and NGAL	BNP≤100pg/ml and NGAL≤153pg/ml
High BNP and Low NGAL Group	BNP and NGAL	BNP\>100pg/ml and NGAL≤153pg/ml
High BNP and High NGAL Group	BNP and NGAL	BNP\>100pg/ml and NGAL\>153pg/ml

Primary Outcome Measures

Name	Time	Method
patient-ventilator synchrony for 30mins	30mins after the patients involved

Secondary Outcome Measures

Name	Time	Method
28-day mortality	28 days after the patients involved
Mechanical ventilation duration between day 1 and day 28	days of mechanical ventilation between day 1 and day 28
the numbers of days in the ICU between day 1 and day 28	the numbers of days in the ICU until day 28