NCT02095275

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

March 10, 2014

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 24, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

March 24, 2014

Status Verified

March 1, 2014

Enrollment Period

2.9 years

First QC Date

March 10, 2014

Last Update Submit

March 20, 2014

Conditions

Keywords

BNP, acute kidney injury, fluid status

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline in serum creatinine level at 3 months

    3 months

Secondary Outcomes (1)

  • Mortality

    1 year

Study Arms (1)

Acute kidney injury

ICU patients with Acute kidney injury

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Critically ill patients in intensive care unit(older than 18 y/o)

You may qualify if:

  • Patients \> 18 y/o in ICU

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum BNP

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Yu-Hsiang Chou, bachelor

    National Taiwan University Hospital

    STUDY DIRECTOR

Central Study Contacts

yu-hsiang chou, bachelor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2014

First Posted

March 24, 2014

Study Start

January 1, 2012

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

March 24, 2014

Record last verified: 2014-03

Locations