The Effect of Vasopressor Therapy on Renal Perfusion in Patients With Septic Shock - a Mechanistically Focussed Randomized Control Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Cortical mean transit time (mTT) measured in seconds
研究概览
简要总结
Acute kidney injury (AKI) is a common complication of septic shock and together these conditions carry a high mortality risk. In septic patients who develop severe AKI renal cortical perfusion is deficient despite normal macrovascular organ blood flow. This intra-renal perfusion abnormality may be amenable to pharmacological manipulation, which may offer mechanistic insight into the pathophysiology of septic AKI. The aim of the current study is to investigate the effects of vasopressin and angiotensin II on renal microcirculatory perfusion in a cohort of patients with septic shock.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
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
- •Within 48 hours of intensive care admission
- •Evidence of suspected or confirmed infection
- •Sequential Organ Failure (SOFA) score increase of 2 or more (assuming a baseline of 0 if no previous measures)
- •Requirement for norepinephrine infusion as the sole vasopressor agent in a dose of >0.1mcg/kg/min
- •Lactate >2mmol/L at any stage prior to randomisation
排除标准
- •Known intolerance to Sonovue™ contrast medium, vasopressin or angiotensin II
- •Patients receiving other vasoactive drugs in addition to norepinephrine
- •Patients with known chronic kidney disease (CKD) stage 4 or 5 (baseline glomerular filtration rate (GFR) <30mls/min)
- •Patients receiving extra corporal membrane oxygenation (ECMO)
- •Patients with acute occlusive coronary syndromes requiring intervention
- •Patients with mesenteric ischaemia
- •Patients with a history or presence of aortic dissection or abdominal aortic aneurysm
- •Patients with Raynaud's syndrome or acute vaso-occlusive conditions
- •Pregnancy
研究组 & 干预措施
Angiotensin II Infusion
Angiotensin II infusion commenced alongside standard care vasopressor therapy (norepinephrine). Angiotensin II up titrated in a protocolised manner to a target/maximum dose of 40 ng/kg/min whilst noradrenaline down titrated in order to achieve/maintain target mean arterial pressure (MAP) as directed by attending clinician.
干预措施: Angiotensin II (Drug)
Angiotensin II Infusion
Angiotensin II infusion commenced alongside standard care vasopressor therapy (norepinephrine). Angiotensin II up titrated in a protocolised manner to a target/maximum dose of 40 ng/kg/min whilst noradrenaline down titrated in order to achieve/maintain target mean arterial pressure (MAP) as directed by attending clinician.
干预措施: Norepinephrine (Drug)
Vasopressin Infusion
Vasopressin infusion commenced alongside standard care vasopressor therapy (norepinephrine). Vasopressin up titrated in a protocolised manner to a target/maximum dose of 0.04 IU/min whilst noradrenaline down titrated in order to achieve/maintain target mean arterial pressure (MAP) as directed by attending clinician.
干预措施: Vasopressin (Drug)
Vasopressin Infusion
Vasopressin infusion commenced alongside standard care vasopressor therapy (norepinephrine). Vasopressin up titrated in a protocolised manner to a target/maximum dose of 0.04 IU/min whilst noradrenaline down titrated in order to achieve/maintain target mean arterial pressure (MAP) as directed by attending clinician.
干预措施: Norepinephrine (Drug)
Norepinephrine Infusion
Standard care vasopressor therapy which recruited participants already receiving, titrated to achieve/maintain target mean arterial pressure (MAP) as directed by attending clinician.
干预措施: Norepinephrine (Drug)
结局指标
主要结局
Cortical mean transit time (mTT) measured in seconds
时间窗: Measured at +24 hours following study vasopressor infusion starting
Contrast enhanced ultrasound measure of renal cortical tissue blood flow
次要结局
- Cortical mean transit time (mTT) measured in seconds(Measured at +1 hour and +24 hours following study vasopressor infusion starting)
- Cortical wash in rate (WiR) measured in arbitrary units(Measured at +1 hour and +24 hours following study vasopressor infusion starting)
- Cortical perfusion index (PI) measured in arbitrary units(Measured at +1 hour and +24 hours following study vasopressor infusion starting)
- Urinary oxygen tension (pO2) across 24 hours study period measured in millimetres of mercury (mmHg)(Across 24 hours study period)
- Tissue inhibitor of metalloproteinases-2 (TIMP-2) and insulin-like growth factor binding protein-7 (IGFBP-7). Both measured in nanograms per millilitre (ng/ml)(Measured at baseline and +24 hours following study vasopressor infusion starting)