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NCT Number: NCT06745206

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

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.

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Key information

Conditions

Sepsis-induced Cardiomyopathy the Recovery Phase of Septic Shock

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Other names: S20050033

Primary outcomes

  1. The pressure gradient of venous return

    Time frame: From baseline to 30 minutes after rh-BNP initiation.

    Pmsf - CVP

Secondary outcomes

  1. Perfusion pressure

    Time frame: 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)

  2. CVP

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

    Absolute and relative changes in CVP

  3. 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.

    Absolute and relative changes in GEDI and global and left-ventricular preload (LVEDV)

  4. Renal microvascular resistance

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

    Absolute and relative changes in renal microvascular resistance

  5. Lactate clearance

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

    Absolute and relative changes in lactate clearance

  6. Duration of invasive mechanical ventilation

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

    Duration of invasive mechanical ventilation

  7. ICU lengths of stay

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

    ICU lengths of stay

Other outcomes

  1. Safety outcome

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Lingai Pan, MD

CONTACT

[email protected]

17708130236

Sponsors and collaborators

Lead sponsor

Sichuan Provincial People's Hospital

Other

Collaborators

  • Tibet Kangzhe Pharmaceutical Development Co., Ltd

Registry information

Official study title

Recombinant Human Brain Natriuretic Peptide for the Recovery Stage of Septic Shock: An Interventional Pilot Study

Acronym: rh-BNP-RSS

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 20, 2024
Registry last updated
Jul 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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