Current partner codePEPTIDESDE
NCT06745206·Not applicable·INTERVENTIONAL

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

Status

Not yet recruiting

Phase

Not applicable

Enrollment

30

Locations

0

Results

Not posted

Publications

1

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

DRUG

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. 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.

Timeline

From registration to results.

  1. First posted

    Dec 20, 2024

  2. Study start

    Dec 2025

  3. Primary completion

    Jun 2026

  4. Study completion

    Sep 2026

  5. Results posted

    Not reported

  6. Registry updated

    Jul 29, 2025

Outcomes

What the study measures.

Primary outcomes

The pressure gradient of venous return

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

Pmsf - CVP

Secondary outcomes

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)

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

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)

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

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

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

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

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

Inclusion criteria: 1. Age \>18 years. 2. Septic shock in recovery phase with decreasing vasopressor requirements, which is defined as: 1. Fulfilling the Sepsis-3 definition of septic shock at initial stage. 2. Hemodynamic stability achieved after adequate initial resuscitation and individualized hemodynamic optimization. 3. Controlled infection source with 48-hour trend of improving temperature, white blood cell count, and procalcitonin. 4. 48-hour trend of decreasing vasopressor requirements and transition to negative fluid balance. 5. Adequate perfusion with warm extremities, and capillary refill time \<3 seconds. 3. Ongoing pulse index continuous cardiac output (PiCCO) hemodynamic monitoring and sinus rhythm. 4. 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. 5. Signs of cardiac dysfunction: BNP\>200\[10\] or NT-proBNP \>900 pg/ml\[6\] or reduced ejection fraction (LVEF) \< 50%. 6. No bolus dose of diuretics had been administered in the previous 6 hours. 7. Informed consent obtained from patient/legal representative. 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 locations

0 registered sites.

No country data reported. Showing up to 24 locations stored in the fast local snapshot.

No study locations reported.

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Put the record in context.

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