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

Not Applicable

Not yet recruiting

• Conditions: the Recovery Phase of Septic Shock; 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

• Study First Submitted: 2024-12-09
• Study First Submitted QC: 2024-12-17
• Study First Posted: 2024-12-20
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-23
• Last Update Posted: 2025-07-29
• Study Start: 2025-12-01
• Primary Completion: 2026-06
• Study Completion: 2026-09-01

Recruitment & Eligibility

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

Inclusion Criteria

Not provided

Exclusion Criteria

1. Pregnancy or lactation.
2. Arrhythmia.
3. 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.
4. Inadequate ultrasound window preventing acquisition of diagnostic-quality images.
5. Trauma or neurological diseases (including intracerebral hemorrhage and cerebral infarction).
6. Pre-existing severe heart failure (New York Heart Association [NYHA] class III-IV) or acute myocardial infarction within the past 30 days.
7. Concurrent enrollment in interventional trials that could confound study outcomes.

Criteria for withdrawing from the study:

1. Withdrawal of the informed consent.
2. Severe hemodynamic deterioration necessitating the discontinuation of all vasodilatory medications.
3. Treating clinician's decision.

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. 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.

Primary Outcome Measures

Name	Time	Method
The pressure gradient of venous return	From baseline to 30 minutes after rh-BNP initiation.	Pmsf - CVP

Secondary Outcome Measures

Name	Time	Method
Perfusion pressure	From baseline to 30 minutes, 24 hours, 48 hours and 72 hours after rh-BNP initiation.	Absolute and relative changes in perfusion pressure (MAP - CVP)
CVP	From baseline to 30 minutes, 24 hours, 48 hours and 72 hours after rh-BNP initiation.	Absolute and relative changes in CVP
ICU lengths of stay	From baseline to 30 minutes, 24 hours, 48 hours and 72 hours after rh-BNP initiation.	ICU lengths of stay
GEDI and global and left-ventricular preload (LVEDV)	From baseline to 30 minutes, 24 hours, 48 hours and 72 hours after rh-BNP initiation.	Absolute and relative changes in GEDI and global and left-ventricular preload (LVEDV)
Lactate clearance	From baseline to 30 minutes, 24 hours, 48 hours and 72 hours after rh-BNP initiation.	Absolute and relative changes in lactate clearance
Duration of invasive mechanical ventilation	From baseline to 30 minutes, 24 hours, 48 hours and 72 hours after rh-BNP initiation.	Duration of invasive mechanical ventilation
Renal microvascular resistance	From baseline to 30 minutes, 24 hours, 48 hours and 72 hours after rh-BNP initiation.	Absolute and relative changes in renal microvascular resistance