Critically IllNCT01344265
The Correlation Between B-type Natriuretic Peptide (BNP) and Global End Diastolic Volume
An observational study of Critically Ill, run by Jinhua Central Hospital at 1 site in China.
Trial summary
The investigators hypothesized that the serum B-type Natriuretic Peptide (BNP) level may be correlated with global end diastolic volume (GEDV) as measured by transpulmonary thermodilution technique (PiCCO). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Critically Ill
- How many people
- 46 participants
- Where
- 1 siteChina
- Study dates
- Jun 2010to Oct 2011
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: critically ill patients who required hemodynamic monitoring using PiCCO
Who may be able to join
- critically ill patients who required hemodynamic monitoring using PiCCO
Who cannot join
- patients with renal dysfunction
- those older than 80 years
- pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Correlation Between BNP and Global End Diastolic Volume
The investigators hypothesized that the serum B-type Natriuretic Peptide (BNP) level may be correlated with global end diastolic volume (GEDV) as measured by transpulmonary thermodilution technique (PiCCO). The rationale is that some animal studies have proven that BNP is released from ventricular myocardium in response to physical expansion. Such physical expansion can be measured by GEDV. If the hypothesis can be confirmed with our study, the serum level BNP can be used to monitor volume status of critically ill patient, instead of the invasive monitoring system.
- Conditions
- Critically Ill
- Keywords
- B-type natriuretic peptide, global end diastolic volume
- Medical subject headings
- Critical Illness
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 |
|---|---|---|
| consecutive patients | there is only one group in our study |
What is being measured
The primary outcome is the main question the study is designed to answer.
global end diastolic volume
this is measured by transpulmonary thermodilution technique
Measured: within 12 h after measurement of BNP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2011 (estimated)
- Study startJun 2010
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critically IllStudies of the same condition, open and under way.
- 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
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jinhua Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhongheng Zhang, Jinhua Central Hospital
- Investigators
- Zhongheng Zhang, MD, Study chair, Jinhua Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01344265
- Sponsor's protocol ID
- zh_zhang1984
- Status last verified
- Sep 2012
- First submitted
- 27 Apr 2011
- Last updated
- 4 Apr 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Correlation Between BNP and Global End Diastolic Volume
- ClinicalTrials.gov ID
- NCT01344265
- Acronym / sponsor ID
- zh_zhang1984
- Conditions
- Critically Ill
- Keywords
- B-type natriuretic peptide, global end diastolic volume
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Jinhua Central HospitalUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 29 Apr 2011 (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.
The investigators hypothesized that the serum B-type Natriuretic Peptide (BNP) level may be correlated with global end diastolic volume (GEDV) as measured by transpulmonary thermodilution technique (PiCCO). The rationale is that some animal studies have proven that BNP is released from ventricular myocardium in response to physical expansion. Such physical expansion can be measured by GEDV. If the hypothesis can be confirmed with our study, the serum level BNP can be used to monitor volume status of critically ill patient, instead of the invasive monitoring system.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| consecutive patients | – | –there is only one group in our study |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- critically ill patients who required hemodynamic monitoring using PiCCO
Key inclusion criteria (1 listed)
- critically ill patients who required hemodynamic monitoring using PiCCO
Key exclusion criteria (3 listed)
- patients with renal dysfunction
- those older than 80 years
- pregnant women
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
global end diastolic volume
Time frame: within 12 h after measurement of BNP
this is measured by transpulmonary thermodilution technique
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2013.
Related trials for Critically Ill
RecruitingPhase 4
Effect of a Furosemide Stress Test-Guided Strategy on Liberation From Continuous Renal Replacement Therapy in Critically Ill Patients With Acute Kidney Injury
Acute Kidney Injury
Not yet recruiting
Building Resilience Through Anxiety Virtual Education in PICU Survivors
Critical Illness Recovery, Mental Health
Active, not recruiting
PICU Up!: A Pilot Stepped-wedge Trial of a Multicomponent Early Mobility Intervention for Critically Ill Children
Critical Illness
RecruitingPhase 3
A Trial of Adjunctive Fludrocortisone (50mcg, 100mcg or Placebo) in Critically Ill Patients With Septic Shock Receiving Hydrocortisone, Evaluating Survival and Functional Recovery and the Influence of Transcriptomic Response
Septic Shock
Not yet recruiting
Feasibility Study on the Use of a Walking Exoskeleton in the Intensive Care Unit
Neuromuscular Disease in Post-Intensive Care Syndrome
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.
Zhongheng Zhang, MD study chair
Jinhua Central 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 Critically Ill, run by Jinhua Central Hospital at 1 site in China.
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 3 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: finished, as of the sponsor's last update on 4 Apr 2013. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
global end diastolic volume (time frame: within 12 h after measurement of BNP). 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 4 Apr 2013.