Sepsis-induced Cardiomyopathyrh-BNP-RSSNCT06745206
Recombinant Human Brain Natriuretic Peptide for the Recovery Stage of Septic Shock
A study testing Lyophilized Recombinant Human Brain Natriuretic Peptide in people with Sepsis-induced Cardiomyopathy and the Recovery Phase of Septic Shock, run by Sichuan Provincial People's Hospital.
Trial summary
As infection control improves and circulation stabilizes, treatment de-escalation of septic shock begins, accompanied by fluid redistribution from interstitial spaces to the vasculature, increasing cardiac volume load. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis-induced Cardiomyopathy, the Recovery Phase of Septic Shock
- What is being tested?
- Lyophilized Recombinant Human Brain Natriuretic Peptide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Dec 2025to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Age >18 years.
- Septic shock in recovery phase with decreasing vasopressor requirements, which is defined as:
- Fulfilling the Sepsis-3 definition of septic shock at initial stage.
- Hemodynamic stability achieved after adequate initial resuscitation and individualized hemodynamic optimization.
- Controlled infection source with 48-hour trend of improving temperature, white blood cell count, and procalcitonin.
- 48-hour trend of decreasing vasopressor requirements and transition to negative fluid balance.
Show all 12Show fewer
- Adequate perfusion with warm extremities, and capillary refill time <3 seconds.
- Ongoing pulse index continuous cardiac output (PiCCO) hemodynamic monitoring and sinus rhythm.
- Volume indicators above the lower limit of normal range, with global end-diastolic volume index (GEDI) >680 mL/m2 and central venous pressure (CVP) >8 mmHg.
- Signs of cardiac dysfunction: BNP>200[10] or NT-proBNP >900 pg/ml[6] or reduced ejection fraction (LVEF) < 50%.
- No bolus dose of diuretics had been administered in the previous 6 hours.
- Informed consent obtained from patient/legal representative.
Who cannot join
- Pregnancy or lactation.
- Arrhythmia.
- Advanced renal dysfunction (Acute Kidney Injury [AKI] stage 3 or Chronic Kidney Disease [CKD] stage 3b or higher) based on Kidney Disease: Improving Global Outcomes (KDIGO) criteria.
- Inadequate ultrasound window preventing acquisition of diagnostic-quality images.
- Trauma or neurological diseases (including intracerebral hemorrhage and cerebral infarction).
- Pre-existing severe heart failure (New York Heart Association [NYHA] class III-IV) or acute myocardial infarction within the past 30 days.
Show all 11Show fewer
- Concurrent enrollment in interventional trials that could confound study outcomes.
- Criteria for withdrawing from the study:
- Withdrawal of the informed consent.
- Severe hemodynamic deterioration necessitating the discontinuation of all vasodilatory medications.
- Treating clinician's decision.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Recombinant Human Brain Natriuretic Peptide for the Recovery Stage of Septic Shock: An Interventional Pilot Study
As infection control improves and circulation stabilizes, treatment de-escalation of septic shock begins, accompanied by fluid redistribution from interstitial spaces to the vasculature, increasing cardiac volume load. Synthetic recombinant human BNP (rh-BNP) plays a role in inducing vasodilation, particularly in the venous system, alleviating cardiac congestion, and enhancing natriuresis and diuresis. Thus the investigators designed a single-center, prospective physiological study to evaluate the efficacy of standard rh-BNP infusion in reducing venous return and enhancing fluid removal, with a secondary objective of assessing the maintenance of perfusion pressure and tissue perfusion.
- Being tested
- Lyophilized Recombinant Human Brain Natriuretic Peptide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lyophilized Recombinant Human Brain Natriuretic PeptideDrug
Also called S20050033
rh-BNP is reconstituted to a concentration of 10 μg/mL and administered as an initial intravenous bolus of 2 μg/kg over 15 minutes, followed by a continuous infusion at a rate of 0.01 μg/kg/min. Patients should receive at least the first 500μg dose infusion, with a recommended duration of 72 hours. The specific timing of discontinuation will be determined by the attending physician. Prior to rh-BNP administration, measure: PiCCO indices, hemodynamic parameters, venous return, tissue perfusion, echocardiographic parameters, ultrasound indices, 2-hour averaged urine output and fluid balance. Repeat all above-mentioned measurements at 30 minutes post-initiation.
| Study group | Role | What they receive |
|---|---|---|
| rh-BNP arm | Experimental | rh-BNP is reconstituted to a concentration of 10 μg/mL and administered as an initial intravenous bolus of 2 μg/kg over 15 minutes, followed by a continuous infusion at a rate of 0.01 μg/kg/min. Patients should receive at least the first 500μg dose infusion, with a recommended duration of 72 hours. The specific timing of discontinuation will be determined by the attending physician. Receives: Drug: Lyophilized Recombinant Human Brain Natriuretic Peptide |
What is being measured
The primary outcome is the main question the study is designed to answer.
The pressure gradient of venous return
Pmsf - CVP
Measured: From baseline to 30 minutes after rh-BNP initiation.
Secondary outcomes (7)
Perfusion pressure
Absolute and relative changes in perfusion pressure (MAP - CVP)
Measured: From baseline to 30 minutes, 24 hours, 48 hours and 72 hours after rh-BNP initiation.
CVP
Absolute and relative changes in CVP
Measured: From baseline to 30 minutes, 24 hours, 48 hours and 72 hours after rh-BNP initiation.
GEDI and global and left-ventricular preload (LVEDV)
Absolute and relative changes in GEDI and global and left-ventricular preload (LVEDV)
Measured: From baseline to 30 minutes, 24 hours, 48 hours and 72 hours after rh-BNP initiation.
Renal microvascular resistance
Absolute and relative changes in renal microvascular resistance
Measured: From baseline to 30 minutes, 24 hours, 48 hours and 72 hours after rh-BNP initiation.
Lactate clearance
Absolute and relative changes in lactate clearance
Measured: From baseline to 30 minutes, 24 hours, 48 hours and 72 hours after rh-BNP initiation.
Duration of invasive mechanical ventilation
Duration of invasive mechanical ventilation
Measured: From baseline to 30 minutes, 24 hours, 48 hours and 72 hours after rh-BNP initiation.
ICU lengths of stay
ICU lengths of stay
Measured: From baseline to 30 minutes, 24 hours, 48 hours and 72 hours after rh-BNP initiation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study startDec 2025 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sepsis-induced CardiomyopathyStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tibet Kangzhe Pharmaceutical Development Co., Ltd
- Responsible party
- Principal investigator, Lingai Pan, Sichuan Provincial People's Hospital
- Investigators
- Lingai Pan, MD, Principal investigator, Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06745206
- Sponsor's protocol ID
- 2024-653-1
- Acronym
- rh-BNP-RSS
- Status last verified
- Jul 2025
- First submitted
- 9 Dec 2024
- Last updated
- 29 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Luo JC, Mou T, Li M, Feng WT, Yue RM, Pan C, Huang XB, Kattan E, Zhang Y, Pan LA. Recombinant human brain natriuretic peptide for the recovery stage of septic shock: an interventional study protocol. BMJ Open. 2026 May 24;16(5):e110628. doi: 10.1136/bmjopen-2025-110628.
PubMed 42192636
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recombinant Human Brain Natriuretic Peptide for the Recovery Stage of Septic Shock: An Interventional Pilot Study
- ClinicalTrials.gov ID
- NCT06745206
- Acronym / sponsor ID
- rh-BNP-RSS / 2024-653-1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sichuan Provincial People's HospitalUniversity, hospital or other
- Collaborators
- Tibet Kangzhe Pharmaceutical Development Co., Ltd
- Study start
- Dec 2025 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 20 Dec 2024 (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.
As infection control improves and circulation stabilizes, treatment de-escalation of septic shock begins, accompanied by fluid redistribution from interstitial spaces to the vasculature, increasing cardiac volume load. Synthetic recombinant human BNP (rh-BNP) plays a role in inducing vasodilation, particularly in the venous system, alleviating cardiac congestion, and enhancing natriuresis and diuresis. Thus the investigators designed a single-center, prospective physiological study to evaluate the efficacy of standard rh-BNP infusion in reducing venous return and enhancing fluid removal, with a secondary objective of assessing the maintenance of perfusion pressure and tissue perfusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| rh-BNP arm | Experimental | Drug: Lyophilized Recombinant Human Brain Natriuretic Peptiderh-BNP is reconstituted to a concentration of 10 μg/mL and administered as an initial intravenous bolus of 2 μg/kg over 15 minutes, followed by a continuous infusion at a rate of 0.01 μg/kg/min. Patients should receive at least the first 500μg dose infusion, with a recommended duration of 72 hours. The specific timing of discontinuation will be determined by the attending physician. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age >18 years.
- Septic shock in recovery phase with decreasing vasopressor requirements, which is defined as:
- Ongoing pulse index continuous cardiac output (PiCCO) hemodynamic monitoring and sinus rhythm.
- Volume indicators above the lower limit of normal range, with global end-diastolic volume index (GEDI) >680 mL/m2 and central venous pressure (CVP) >8 mmHg.
- Signs of cardiac dysfunction: BNP>200[10] or NT-proBNP >900 pg/ml[6] or reduced ejection fraction (LVEF) < 50%.
Key exclusion criteria (11 listed)
- Pregnancy or lactation.
- Arrhythmia.
- Advanced renal dysfunction (Acute Kidney Injury [AKI] stage 3 or Chronic Kidney Disease [CKD] stage 3b or higher) based on Kidney Disease: Improving Global Outcomes (KDIGO) criteria.
- Inadequate ultrasound window preventing acquisition of diagnostic-quality images.
- Trauma or neurological diseases (including intracerebral hemorrhage and cerebral infarction).
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 |
|---|---|---|
| Lyophilized Recombinant Human Brain Natriuretic PeptideAlso: S20050033rh-BNP is reconstituted to a concentration of 10 μg/mL and administered as an initial intravenous bolus of 2 μg/kg over 15 minutes, followed by a continuous infusion at a rate of 0.01 μg/kg/min. Patients should receive at least the first 500μg dose infusion, with a recommended duration of 72 hours. The specific timing of discontinuation will be determined by the attending physician. Prior to rh-BNP administration, measure: PiCCO indices, hemodynamic parameters, venous return, tissue perfusion, echocardiographic parameters, ultrasound indices, 2-hour averaged urine output and fluid balance. Repeat all above-mentioned measurements at 30 minutes post-initiation. | Drug | rh-BNP arm |
Primary outcome
The pressure gradient of venous return
Time frame: From baseline to 30 minutes after rh-BNP initiation.
Pmsf - CVP
7 secondary outcomes
Perfusion pressure
Time frame: From baseline to 30 minutes, 24 hours, 48 hours and 72 hours after rh-BNP initiation.
CVP
Time frame: From baseline to 30 minutes, 24 hours, 48 hours and 72 hours after rh-BNP initiation.
GEDI and global and left-ventricular preload (LVEDV)
Time frame: From baseline to 30 minutes, 24 hours, 48 hours and 72 hours after rh-BNP initiation.
Renal microvascular resistance
Time frame: From baseline to 30 minutes, 24 hours, 48 hours and 72 hours after rh-BNP initiation.
Lactate clearance
Time frame: From baseline to 30 minutes, 24 hours, 48 hours and 72 hours after rh-BNP initiation.
Duration of invasive mechanical ventilation
Time frame: From baseline to 30 minutes, 24 hours, 48 hours and 72 hours after rh-BNP initiation.
ICU lengths of stay
Time frame: From baseline to 30 minutes, 24 hours, 48 hours and 72 hours after rh-BNP initiation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2025.
- Derived from this study: PubMed 42192636Luo JC, Mou T, Li M, Feng WT, Yue RM, Pan C, Huang XB, Kattan E, Zhang Y, Pan LA. Recombinant human brain natriuretic peptide for the recovery stage of septic shock: an interventional study protocol. BMJ Open. 2026 May 24;16(5):e110628. doi: 10.1136/bmjopen-2025-110628.
- Individual participant dataSharing planned: No
Related trials for Sepsis-induced Cardiomyopathy
RecruitingObservational study
Prognostic Value of Right Ventricular-pulmonary Arterial Coupling Assessed by Echocardiography in Septic Patients
Sepsis
Not yet recruitingObservational study
Sepsis Induced Myocardial Injury in Critically Ill Children
Sepsis Induced Cardiomyopathy, Sepsis Induced Myocardial Dysfunction
Not yet recruiting
Hemodynamic Effects of Ketone Esters in Patients With Sepsis Induced Cardiomyopathy
Sepsis Induced Cardiomyopathy
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.
Lingai Pan, MD principal investigator
Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Lyophilized Recombinant Human Brain Natriuretic Peptide in people with Sepsis-induced Cardiomyopathy and the Recovery Phase of Septic Shock, run by Sichuan Provincial People's Hospital.
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 12 inclusion and 11 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: opening soon, as of the sponsor's last update on 29 Jul 2025. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lingai Pan, MD (17708130236, panlingai2004@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The pressure gradient of venous return (time frame: From baseline to 30 minutes after rh-BNP initiation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06745206, which also lists 1 linked publication.
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 29 Jul 2025.