Recombinant Human Brain Natriuretic Peptide for the Recovery Stage of Septic Shock: An Interventional Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 主要终点
- The pressure gradient of venous return
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Lyophilized Recombinant Human Brain Natriuretic Peptide (Drug)
结局指标
主要结局
The pressure gradient of venous return
时间窗: From baseline to 30 minutes after rh-BNP initiation.
Pmsf - CVP
次要结局
- Perfusion pressure(From baseline to 30 minutes, 24 hours, 48 hours and 72 hours after rh-BNP initiation.)
- CVP(From baseline to 30 minutes, 24 hours, 48 hours and 72 hours after rh-BNP initiation.)
- ICU lengths of stay(From baseline to 30 minutes, 24 hours, 48 hours and 72 hours after rh-BNP initiation.)
- GEDI and global and left-ventricular preload (LVEDV)(From baseline to 30 minutes, 24 hours, 48 hours and 72 hours after rh-BNP initiation.)
- Lactate clearance(From baseline to 30 minutes, 24 hours, 48 hours and 72 hours after rh-BNP initiation.)
- Duration of invasive mechanical ventilation(From baseline to 30 minutes, 24 hours, 48 hours and 72 hours after rh-BNP initiation.)
- Renal microvascular resistance(From baseline to 30 minutes, 24 hours, 48 hours and 72 hours after rh-BNP initiation.)
研究者
Lingai Pan
associate chief physician
Sichuan Provincial People's Hospital