Recombinant Human Brain Natriuretic Peptide for the Recovery Stage of Septic Shock

Phase 1

Not yet recruiting

• Conditions: Sepsis-induced Cardiomyopathy
• Interventions: Drug: Lyophilized Recombinant Human Brain Natriuretic Peptide

• Registration Number: NCT06745206
• Lead Sponsor: Sichuan Provincial People's Hospital

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study Start: 2024-12
• Study First Submitted: 2024-12-09
• Study First Submitted QC: 2024-12-17
• Last Update Submitted: 2024-12-17
• Study First Posted: 2024-12-20
• Last Update Posted: 2024-12-20
• Primary Completion: 2025-09
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Sepsis-3 criteria met with Sequential Organ Failure Assessment (SOFA) score increase ≥2 points due to suspected/documented infection.
2. Hypotension persisting after initial fluid resuscitation with concurrent hyperlactatemia at shock diagnosis.
3. Hemodynamic stability achieved after adequate initial resuscitation and individualized hemodynamic optimization.
4. Controlled infection source with improving temperature, white blood cell (WBC) count, and procalcitonin.
5. 48-hour trend of decreasing vasopressor requirements and transition to negative fluid balance.
6. Ongoing pulse index continuous cardiac output (PiCCO) hemodynamic monitoring and sinus rhythm.
7. 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 mmHg8.
8. Adequate perfusion with warm extremities, and capillary refill time (CRT) <3 seconds9.
9. Signs of cardiac dysfunction: BNP>20010 or NT-proBNP >900 pg/ml6 or reduced ejection fraction (LVEF < 50%).
10. No bonus dose of diuretics has been used in the past 6 hour.

Read More

Exclusion Criteria

1. Age <18 years.
2. Pregnancy or lactation.
3. Arrhythmia.
4. Persistent dependence on moderate-dose vasopressors (norepinephrine equivalent 0.1-0.3 μg/kg/min) to maintain systolic blood pressure (SBP) <90 and mean arterial pressure (MAP) ≥65 mmHg.
5. 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.
6. Inadequate ultrasound window preventing acquisition of diagnostic-quality images.
7. Altered mental status impeding patient cooperation.
8. Trauma or neurological diseases (including intracerebral hemorrhage and cerebral infarction).
9. Pre-existing severe heart failure (New York Heart Association [NYHA] class III-IV) or acute myocardial infarction within the past 30 days.
10. Concurrent enrollment in interventional trials that could confound study outcomes.
11. Inability or unwillingness to provide informed consent.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
rh-BNP arm	Lyophilized Recombinant Human Brain Natriuretic Peptide	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. The outcomes were measured 30 minutes after intervention. After that, according to the judgment of the clinicians, rh-BNP could be applied for up to 3 days.

Primary Outcome Measures

Name	Time	Method
The pressure gradient of venous return	30 minutes after intervention	Pmsf - CVP

Secondary Outcome Measures

Name	Time	Method
The reduction in LVEDV	30 minutes after intervention	The reduction in LVEDV
The reduction in tissue perfusion pressure	30 minutes after intervention	The reduction in tissue perfusion pressure
The reduction in CVP	30 minutes after intervention	The reduction in CVP
The reduction in GEDI	30 minutes after intervention	The reduction in GEDI
The reduction in RRI	30 minutes after intervention	The reduction in RRI