Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Tibet Kangzhe Pharmaceutical Development Co., Ltd | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lyophilized Recombinant Human Brain Natriuretic Peptide | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The pressure gradient of venous return | Pmsf - CVP | From baseline to 30 minutes after rh-BNP initiation. |
| Measure | Description | Time Frame |
|---|---|---|
| Perfusion pressure | Absolute and relative changes in perfusion pressure (MAP - CVP) | From baseline to 30 minutes, 24 hours, 48 hours and 72 hours after rh-BNP initiation. |
| CVP | Absolute and relative changes in CVP |
| Measure | Description | Time Frame |
|---|---|---|
| Safety outcome | The safety outcome was hemodynamic instability, defined as a sustained (≥15 minutes) decrease in systolic blood pressure ≥ 10 mmHg or MAP ≥ 5 mmHg compared with baseline, or a requirement for ≥ 0.1 µg/kg/min increase in norepinephrine to maintain MAP ≥ 65 mmHg. | From baseline to 30 minutes, 24 hours, 48 hours and 72 hours after rh-BNP initiation. |
Inclusion criteria:
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%.
No bolus dose of diuretics had been administered in the previous 6 hours.
Informed consent obtained from patient/legal representative.
Exclusion Criteria:
Criteria for withdrawing from the study:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lingai Pan, MD | Contact | 17708130236 | panlingai2004@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Lingai Pan, MD | Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospital | Principal Investigator |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42192636 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| 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) | 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 | 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 | 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 | From baseline to 30 minutes, 24 hours, 48 hours and 72 hours after rh-BNP initiation. |
| ICU lengths of stay | ICU lengths of stay | From baseline to 30 minutes, 24 hours, 48 hours and 72 hours after rh-BNP initiation. |