Acute Kidney Injury (Nontraumatic)NCT02095275
Exploring the Relationship Among BNP, Fluid Status and Acute Kidney Injury in Critically Ill Patients
An observational study of Acute Kidney Injury (Nontraumatic), run by National Taiwan University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury (Nontraumatic)
- How many people
- 300 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2012to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Critically ill patients in intensive care unit(older than 18 y/o)
Who may be able to join
- Patients > 18 y/o in ICU
Who cannot join
- 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)
Show all 9Show fewer
- Terminal cancer patients
- Patients with Bosmina therapy
- Patients received CPR (IHCA or OHCA)
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
yu-hsiang chou, bachelor, +886-2-23123456, chouyuhsiang@yahoo.com.tw
About this study
Official title: Exploring the Relationship Among Brain Natriuretic Peptide, Fluid Status and Acute Kidney Injury in Critically Ill Patients
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.
Read the detailed 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.
- Conditions
- Acute Kidney Injury (Nontraumatic)
- Keywords
- BNP, acute kidney injury, fluid status
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Acute kidney injury | ICU patients with Acute kidney injury |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in serum creatinine level at 3 months
Measured: 3 months
Secondary outcomes (1)
Mortality
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2014 (estimated)
- Study startJan 2012
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney Injury (Nontraumatic)Studies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yu-Hsiang Chou, bachelor, Study director, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02095275
- Sponsor's protocol ID
- 201111012RIB
- Status last verified
- Mar 2014
- First submitted
- 10 Mar 2014
- Last updated
- 24 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Relationship Among Brain Natriuretic Peptide, Fluid Status and Acute Kidney Injury in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT02095275
- Acronym / sponsor ID
- 201111012RIB
- Conditions
- Acute Kidney Injury (Nontraumatic)
- Keywords
- BNP, acute kidney injury, fluid status
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 24 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute kidney injury | – | –ICU patients with Acute kidney injury |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients in intensive care unit(older than 18 y/o)
Key inclusion criteria (1 listed)
- Patients > 18 y/o in ICU
Key exclusion criteria (9 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change from Baseline in serum creatinine level at 3 months
Time frame: 3 months
1 secondary outcome
Mortality
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yu-Hsiang Chou, bachelor study director
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury (Nontraumatic), run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact yu-hsiang chou, bachelor (+886-2-23123456, chouyuhsiang@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in serum creatinine level at 3 months (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2014.