SepsisNCT05111769
Preliminary Study on the Clinical Effect of Recombinant Human Brain Natriuretic Peptide on Sepsis Complicated With Heart Failure
A study testing Recombinant human brain natriuretic peptide in people with Sepsis, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
The investigators intend to conduct clinical studies to determine the efficacy of rhBNP in the treatment of septic related dysfunction and kidney dysfunction Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Sepsis
- What is being tested?
- Recombinant human brain natriuretic peptide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2021to 1 Dec 2023
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- sepsis complicated with heart failure（Diagnosed by sepsis 3.0）
- Heart failure: BNP rises by 600 pg/ml
- Age>=18 years old
Who cannot join
- Hemodynamically unstable
- Pregnant
- Disagree with comprehensive and active life support treatment
- coronary heart disease, myocardial infarction, and cardiac insufficiency
- chronic renal insufficiency
Trial locations and contacts
1 site in 1 country.
About this study
The investigators intend to conduct clinical studies to determine the efficacy of rhBNP in the treatment of septic related dysfunction and kidney dysfunction
Read the detailed description
Sepsis is one of the common critical diseases in ICU with high mortality. Septic shock patients are often accompanied by multiple organ dysfunction (MODS), of which more than 50% of patients with varying degrees of myocardial injury.The investigators hope to find a drug with a protective effect on cardiac function and kidney function, so as to treat sepsis more effectively in the treatment of sepsis.
Recombinant human brain natriuretic peptide (rhBNP) was approved by FDA in 2001 for the treatment of acute decompensated heart failure.These effects play a role in the protection of cardiac and kidney function, and have achieved good results in patients with cardiac insufficiency and AKI caused by cardiac surgery.
The investigators are going to carry out related research from the following aspects: 1. To determine the effect of rhBNP on hemodynamics in sepsis based on PiCCO hemodynamic monitoring; 2. To collect and sort out the relevant data to determine the effects of rhBNP on cardiac function and kidney function, including cardiac ultrasound, kidney blood flow index and related laboratory tests. 3. To determine the effect of rhBNP on the final prognosis of patients, including ICU mortality and hospital mortality, ICU time, hospital stay, ventilator use time, kidney replacement therapy time, vasoactive drug dosage and time.
- Conditions
- Sepsis
- Being tested
- Recombinant human brain natriuretic peptide
- Keywords
- sepsis, Heart Failure, AKI
- Medical subject headings
- Sepsis, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant human brain natriuretic peptideDrug
- To determine the effect of rhBNP on hemodynamics in sepsis based on PiCCO hemodynamic monitoring; 2. To collect and sort out the relevant data to determine the effects of rhBNP on cardiac function and kidney function, including cardiac ultrasound, kidney blood flow index and related laboratory tests. 3. To determine the effect of rhBNP on the final prognosis of patients, including ICU mortality and hospital mortality, ICU time, hospital stay, ventilator use time, kidney replacement therapy time, vasoactive drug dosage and time.
| Study group | Role | What they receive |
|---|---|---|
| rhBNP in the treatment of sepsis complicated with heart failure | Experimental | Recombinant human brain natriuretic peptide (rhBNP) on sepsis complicated with heart failure Receives: Drug: Recombinant human brain natriuretic peptide |
| Conventional treatment group | No intervention | Do not use recombinant human brain natriuretic peptide (rhBNP) to treat sepsis with heart failure |
What is being measured
The primary outcome is the main question the study is designed to answer.
the effects of rhBNP(recombinant human brain natriuretic peptide) on cardiac function
The decreasing trend of NTproBNP(N-terminal pro-B-type natriuretic peptide)
Measured: 72 hours after rhBNP
PiCCO hemodynamic monitoring in recombinant human brain natriuretic peptide group
The improvement degree of cardiac index in recombinant human brain natriuretic peptide group
Measured: 72 hours after recombinant human brain natriuretic peptide
Secondary outcomes (2)
ICU mortality and hospital mortality
Comparison between rhBNP group and control group
Measured: One month after entering ICU
Mechanical ventilation time after entering ICU
Comparison between rhBNP group and control group
Measured: 72 hours after recombinant human brain natriuretic peptide
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2021
- Study start1 Dec 2021 (estimated)
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05111769
- Sponsor's protocol ID
- SEPSIS-HF
- Status last verified
- Oct 2021
- First submitted
- 30 Sep 2021
- Last updated
- 8 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Study on the Clinical Effect of Recombinant Human Brain Natriuretic Peptide on Sepsis Complicated With Heart Failure
- ClinicalTrials.gov ID
- NCT05111769
- Acronym / sponsor ID
- SEPSIS-HF
- Conditions
- Sepsis
- Keywords
- sepsis, Heart Failure, AKI
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Dec 2021 (estimated)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 8 Nov 2021 (actual)
- 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 intend to conduct clinical studies to determine the efficacy of rhBNP in the treatment of septic related dysfunction and kidney dysfunction
Detailed description
Sepsis is one of the common critical diseases in ICU with high mortality. Septic shock patients are often accompanied by multiple organ dysfunction (MODS), of which more than 50% of patients with varying degrees of myocardial injury.The investigators hope to find a drug with a protective effect on cardiac function and kidney function, so as to treat sepsis more effectively in the treatment of sepsis.
Recombinant human brain natriuretic peptide (rhBNP) was approved by FDA in 2001 for the treatment of acute decompensated heart failure.These effects play a role in the protection of cardiac and kidney function, and have achieved good results in patients with cardiac insufficiency and AKI caused by cardiac surgery.
The investigators are going to carry out related research from the following aspects: 1. To determine the effect of rhBNP on hemodynamics in sepsis based on PiCCO hemodynamic monitoring; 2. To collect and sort out the relevant data to determine the effects of rhBNP on cardiac function and kidney function, including cardiac ultrasound, kidney blood flow index and related laboratory tests. 3. To determine the effect of rhBNP on the final prognosis of patients, including ICU mortality and hospital mortality, ICU time, hospital stay, ventilator use time, kidney replacement therapy time, vasoactive drug dosage and time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rhBNP in the treatment of sepsis complicated with heart failure | Experimental | Drug: Recombinant human brain natriuretic peptideRecombinant human brain natriuretic peptide (rhBNP) on sepsis complicated with heart failure |
| Conventional treatment group | No intervention | –Do not use recombinant human brain natriuretic peptide (rhBNP) to treat sepsis with heart failure |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- sepsis complicated with heart failure（Diagnosed by sepsis 3.0）
- Heart failure: BNP rises by 600 pg/ml
- Age>=18 years old
Key exclusion criteria (5 listed)
- Hemodynamically unstable
- Pregnant
- Disagree with comprehensive and active life support treatment
- coronary heart disease, myocardial infarction, and cardiac insufficiency
- chronic renal insufficiency
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 |
|---|---|---|
| Recombinant human brain natriuretic peptide1. To determine the effect of rhBNP on hemodynamics in sepsis based on PiCCO hemodynamic monitoring; 2. To collect and sort out the relevant data to determine the effects of rhBNP on cardiac function and kidney function, including cardiac ultrasound, kidney blood flow index and related laboratory tests. 3. To determine the effect of rhBNP on the final prognosis of patients, including ICU mortality and hospital mortality, ICU time, hospital stay, ventilator use time, kidney replacement therapy time, vasoactive drug dosage and time. | Drug | rhBNP in the treatment of sepsis complicated with heart failure |
Primary outcome
the effects of rhBNP(recombinant human brain natriuretic peptide) on cardiac function
Time frame: 72 hours after rhBNP
The decreasing trend of NTproBNP(N-terminal pro-B-type natriuretic peptide)
PiCCO hemodynamic monitoring in recombinant human brain natriuretic peptide group
Time frame: 72 hours after recombinant human brain natriuretic peptide
The improvement degree of cardiac index in recombinant human brain natriuretic peptide group
2 secondary outcomes
ICU mortality and hospital mortality
Time frame: One month after entering ICU
Mechanical ventilation time after entering ICU
Time frame: 72 hours after recombinant human brain natriuretic peptide
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recombinant human brain natriuretic peptide in people with Sepsis, run by Shanghai Zhongshan 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 3 inclusion and 5 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 8 Nov 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Minjie Ju, PHD (8613817014079, ju.minjie@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the effects of rhBNP(recombinant human brain natriuretic peptide) on cardiac function (time frame: 72 hours after rhBNP). The study lists 2 primary outcomes in all. 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 8 Nov 2021.