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

NCT ID: NCT06745206

Last Updated: 2025-07-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2026-09-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

rh-BNP arm

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.

Group Type: EXPERIMENTAL

Lyophilized Recombinant Human Brain Natriuretic Peptide

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

S20050033

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tibet Kangzhe Pharmaceutical Development Co., Ltd

UNKNOWN

Sponsor Role: collaborator

Sichuan Provincial People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Lingai Pan

associate chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lingai Pan, MD

Role: PRINCIPAL_INVESTIGATOR

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

Central Contacts

Lingai Pan, MD

Role: CONTACT

panlingai2004@163.com

17708130236

Other Identifiers

2024-653-1

Identifier Type: -

Identifier Source: org_study_id