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

Launched by SICHUAN PROVINCIAL PEOPLE'S HOSPITAL · Dec 17, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called recombinant human brain natriuretic peptide (rh-BNP) for patients recovering from septic shock, a serious condition that affects the heart and blood circulation due to severe infections. The goal is to see if rh-BNP can help improve heart function and fluid management in these patients, making it easier for their bodies to recover. This study will involve a small group of participants at one location, and it aims to find out if this treatment can reduce the pressure in the veins and help remove excess fluid while maintaining good blood flow to the organs.

To be eligible for the trial, participants should be adults aged 65 and older who have been diagnosed with septic shock and are showing signs of improving health after initial treatment. They should also be stable after receiving fluids and have specific heart function measurements that indicate they could benefit from rh-BNP. Participants will be monitored closely during the trial, and the study team will ensure they understand the process and give their consent to participate. This is an important step in finding better treatments for patients with sepsis-related heart issues.

Gender

ALL

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.