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

NCT06745206 | Not Yet Recruiting

• 1 other identifier: 2024-653-1
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Sepsis-induced Cardiomyopathy; the Recovery Phase of Septic Shock

Outcome Measures

Primary Outcomes (1)

• The pressure gradient of venous return

  Pmsf - CVP

  From baseline to 30 minutes after rh-BNP initiation.

Secondary Outcomes (7)

• Perfusion pressure

  From baseline to 30 minutes, 24 hours, 48 hours and 72 hours after rh-BNP initiation.

• CVP

  From baseline to 30 minutes, 24 hours, 48 hours and 72 hours after rh-BNP initiation.

• 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

  From baseline to 30 minutes, 24 hours, 48 hours and 72 hours after rh-BNP initiation.

• Lactate clearance

  From baseline to 30 minutes, 24 hours, 48 hours and 72 hours after rh-BNP initiation.

Other Outcomes (1)

• Safety outcome

  From baseline to 30 minutes, 24 hours, 48 hours and 72 hours after rh-BNP initiation.

Study Arms (1)

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.

Drug: Lyophilized Recombinant Human Brain Natriuretic Peptide

Interventions

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.

Also known as: S20050033

rh-BNP arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• hour trend of decreasing vasopressor requirements and transition to negative fluid balance.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Sichuan Provincial People's Hospital: lead
• Tibet Kangzhe Pharmaceutical Development Co., Ltd: collaborator

Study Officials

• Lingai Pan, MD

  Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lingai Pan, MD

CONTACT

17708130236; panlingai2004@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate chief physician

Study Record Dates

• First Submitted: December 9, 2024
• First Posted: December 20, 2024
• Study Start: December 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: July 29, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share