Exploring the Relationship Among BNP, Fluid Status and Acute Kidney Injury in Critically Ill Patients

Acute Kidney Injury (Nontraumatic) Clinical Trial

Official title:

Exploring the Relationship Among Brain Natriuretic Peptide, Fluid Status and Acute Kidney Injury in Critically Ill Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02095275
• Other study ID #: 201111012RIB
• Status: Recruiting
• Phase: N/A
• First received: March 10, 2014
• Last updated: March 20, 2014
• Start date: January 2012
• Est. completion date: December 2014

Study information

• Verified date: March 2014
• Source: National Taiwan University Hospital
• Contact: yu-hsiang chou, bachelor
• Phone: +886-2-23123456
• Email: chouyuhsiang[@]yahoo.com.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial Summary

B-type natriuretic peptide (BNP) is rapidly released by the ventricles of the heart in response to myocardial stretch. This cardiac neurohormone is mostly elevated in patients with fluid overload or myocardium dysfunction. BNP is a very useful and important marker. It can predict mortality and cardiac events in patients in the ICU setting. In stable hemodialysis patients with normal LV function on echocardiography, high BNP levels are likely the result of blood volume expansion and require reduction in postdialysis dry weight.

In the past, there were many methods to evaluate fluid status. Some are not reliable such as central venous pressure or physical examination. Some are invasive and expensive such as Swan Ganz、PiCCO catheter or bioimpedance device. Nevertheless, About the relationship between BNP and fluid status, a study found a significant relation between bioimpedance-derived body composition (BC) (fluid distribution) parameters and BNP concentrations. This relationship was independent of the cardiac history of the patient and suggests that the natriuretic peptide levels are to some degree modifiable by changing a patient's fluid distribution.

In this study, the investigators want to observe that if the level of BNP can predict the occurrence of acute kidney injury and the need of renal replacement therapy. Besides, the investigators also want to see if BNP can be a useful and convenient marker to guide adjustment of optimal fluid status and then to improve outcome.

Description:

B-type natriuretic peptide (BNP) is rapidly released by the ventricles of the heart in response to myocardial stretch. This cardiac neurohormone is mostly elevated in patients with fluid overload or myocardium dysfunction. BNP is a very useful and important marker. It can predict mortality and cardiac events in patients in the ICU setting. In stable hemodialysis patients with normal LV function on echocardiography, high BNP levels are likely the result of blood volume expansion and require reduction in postdialysis dry weight.

On the other hand, ample recent data have highlighted the role of fluid accumulation on mortality and non-recovery of kidney function in critically ill patients with acute kidney injury (AKI). In the past, there were many methods to evaluate fluid status. Some are not reliable such as central venous pressure or physical examination. Some are invasive and expensive such as Swan Ganz、PiCCO catheter or bioimpedance device. Nevertheless, About the relationship between BNP and fluid status, a study found a significant relation between bioimpedance-derived body composition (BC) (fluid distribution) parameters and BNP concentrations. This relationship was independent of the cardiac history of the patient and suggests that the natriuretic peptide levels are to some degree modifiable by changing a patient's fluid distribution.

In this study, we want to observe that if the level of BNP can predict the occurrence of acute kidney injury and the need of renal replacement therapy. Besides, we also want to see if BNP can be a useful and convenient marker to guide adjustment of optimal fluid status and then to improve outcome.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients > 18 y/o in ICU

Exclusion Criteria:

• Acute coronary syndrome

• Congestive heart failure history

• Clinical pulmonary hypertension with various cause (iPAH, congenital heart disease, CTEPH, COPD with cor pulmonate,…)

• Patients with acute pulmonary embolism

• Chronic atrial fibrillation,

• Respiratory failure with high PEEP (>10 CmH2)

• Terminal cancer patients

• Patients with Bosmina therapy

• Patients received CPR (IHCA or OHCA)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Kidney Injury
• Acute Kidney Injury (Nontraumatic)
• Critical Illness

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in serum creatinine level at 3 months		3 months	No
Secondary	Mortality		1 year	No