28-day MortalityNCT02871544
Predictive Value of Dynamic Combination of BNP and NGAL for the Prognosis of Patients With Sepsis
A study testing BNP and NGAL in people with 28-day Mortality and Sepsis, run by Southeast University, China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- 28-day Mortality, Sepsis
- What is being tested?
- BNP and NGAL
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to Feb 2016
- Phase
- Interventional
- 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
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Predictive Value of Dynamic Combination of B-type Natriuretic Peptide and Neutrophil Gelatinase-associated Lipocalin for the Prognosis of Patients With Sepsis
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.
- Conditions
- 28-day Mortality, Sepsis
- Being tested
- BNP and NGAL
- Keywords
- BNP, NGAL, Sepsis, Mortality
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BNP and NGALOther
| Study group | Role | What they receive |
|---|---|---|
| Low BNP and Low NGAL Group | Sham comparator | BNP≤100pg/ml and NGAL≤153pg/ml Receives: Other: BNP and NGAL |
| High BNP and Low NGAL Group | Active comparator | BNP>100pg/ml and NGAL≤153pg/ml Receives: Other: BNP and NGAL |
| Low BNP and High NGAL Group | Active comparator | BNP≤100pg/ml and NGAL>153pg/ml Receives: Other: BNP and NGAL |
| High BNP and High NGAL Group | Active comparator | BNP>100pg/ml and NGAL>153pg/ml Receives: Other: BNP and NGAL |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient-ventilator synchrony for 30mins
Measured: 30mins after the patients involved
Secondary outcomes (3)
the numbers of days in the ICU between day 1 and day 28
Measured: the numbers of days in the ICU until day 28
Mechanical ventilation duration between day 1 and day 28
Measured: days of mechanical ventilation between day 1 and day 28
28-day mortality
Measured: 28 days after the patients involved
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2016 (estimated)
- Study startJun 2015
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 28-day MortalityStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chun Pan, Zhongda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02871544
- Sponsor's protocol ID
- Zhongda Hospital AKI
- Status last verified
- Aug 2016
- First submitted
- 25 Jul 2016
- Last updated
- 18 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of Dynamic Combination of B-type Natriuretic Peptide and Neutrophil Gelatinase-associated Lipocalin for the Prognosis of Patients With Sepsis
- ClinicalTrials.gov ID
- NCT02871544
- Acronym / sponsor ID
- Zhongda Hospital AKI
- Conditions
- 28-day Mortality, Sepsis
- Keywords
- BNP, NGAL, Sepsis, Mortality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 18 Aug 2016 (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.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low BNP and Low NGAL Group | Sham comparator | Other: BNP and NGALBNP≤100pg/ml and NGAL≤153pg/ml |
| High BNP and Low NGAL Group | Active comparator | Other: BNP and NGALBNP>100pg/ml and NGAL≤153pg/ml |
| Low BNP and High NGAL Group | Active comparator | Other: BNP and NGALBNP≤100pg/ml and NGAL>153pg/ml |
| High BNP and High NGAL Group | Active comparator | Other: BNP and NGALBNP>100pg/ml and NGAL>153pg/ml |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BNP and NGAL | Other | High BNP and High NGAL Group, High BNP and Low NGAL Group, Low BNP and High NGAL Group, Low BNP and Low NGAL Group |
Primary outcome
patient-ventilator synchrony for 30mins
Time frame: 30mins after the patients involved
3 secondary outcomes
the numbers of days in the ICU between day 1 and day 28
Time frame: the numbers of days in the ICU until day 28
Mechanical ventilation duration between day 1 and day 28
Time frame: days of mechanical ventilation between day 1 and day 28
28-day mortality
Time frame: 28 days after the patients involved
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 18 Aug 2016.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing BNP and NGAL in people with 28-day Mortality and Sepsis, run by Southeast University, 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 3 inclusion and 7 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 18 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
patient-ventilator synchrony for 30mins (time frame: 30mins after the patients involved). 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 18 Aug 2016.