Recombinant Human Brain Natriuretic Peptide for the Recovery Stage of Septic Shock
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSichuan Provincial People's Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age >18 years.
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Lyophilized Recombinant Human Brain Natriuretic Peptide
Drugrh-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.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: rh-BNP armExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The pressure gradient of venous return
Pmsf - CVP
Time frame
From baseline to 30 minutes after rh-BNP initiation.Secondary outcomes
1
Perfusion pressure
Absolute and relative changes in perfusion pressure (MAP - CVP)
Time frame
From baseline to 30 minutes, 24 hours, 48 hours and 72 hours after rh-BNP initiation.2
CVP
Absolute and relative changes in CVP
Time frame
From baseline to 30 minutes, 24 hours, 48 hours and 72 hours after rh-BNP initiation.3
GEDI and global and left-ventricular preload (LVEDV)
Absolute and relative changes in 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.4
Renal microvascular resistance
Absolute and relative changes in renal microvascular resistance
Time frame
From baseline to 30 minutes, 24 hours, 48 hours and 72 hours after rh-BNP initiation.Other outcomes
1
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.
Time frame
From baseline to 30 minutes, 24 hours, 48 hours and 72 hours after rh-BNP initiation.Locations
Sponsors and contacts
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Sichuan Provincial People's Hospital
Lead sponsor
Tibet Kangzhe Pharmaceutical Development Co., Ltd
Collaborator
Source ClinicalTrials.gov
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