Effects of Increasing Mean Arterial Pressure on Renal Function in Patients With Shock and With Elevated Central Venous Pressure : a Pilot Study for the Individualization of Mean Arterial Pressure
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Changes of creatinine clearance
研究概览
简要总结
The purpose of this study is to assess the effect of a higher mean arterial pressure on renal function for patients with shock and elevated central venous pressure.
详细描述
Current recommandation for mean arterial pressure (MAP) target is 65 mmHg for septic shock, but optimal target to prevent acute renal failure (ARF) remains unknown.
High central venous pressure (CVP) can lead to acute renal failure through venous congestion , and is associated with acute renal failure in intensive care unit.
A decrease of renal perfusion pressure, defined by MAP - CVP, has been shown to be associated with risk of acute renal failure.
The main objective of this trial is to evaluate if an optimisation of renal perfusion pressure, by a higher MAP when CVP is high (≥ 12 cmH2O), can improve renal function.
In this interventional monocenter trial, each patient will be evaluated during 2 consecutive periods of 6 hours, with a temporary MAP target
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 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
- •Adult patients (≥ 18 years old )
- •Arterial hypotension requiring the etablishment of catecholamines
- •Norepinephrine dose ⩾ 0.1µg/kg/min at the inclusion
- •High central venous pressure ≥ 12mmHg
- •Cardiac output monitoring (PICCO or Swan Ganz)
排除标准
- •Patient with an emergency indication of renal replacement therapy (severe hyperkalemia, severe metabolical acidosis with pH <7.15, acute pulmonary edema due to fluid overload resulting in severe hypoxemia, serum urea concentration > 40 mmol/l)
- •Pregnant, lactating or parturient woman
- •Patient deprived of liberty by judicial or administrative decision
- •Patient with psychiatric compulsory care
- •Patient subject to legal protection measures
- •Patients with do-no-reanimate order or withdrawal of life sustaining support
研究组 & 干预措施
Increase of MAP at low target 65-70 mmHg (with catecholamines or volemic expansion)
Target of mean arterial pressure (MAP) at 65-70 mmHg The therapeutic means used to obtain the MAP objectives within each group (increase in catecholamines and / or volume expansion) are left to the discretion of the clinician, in accordance with the recommendations.
干预措施: increase of mean arterial pressure at 65-70 mmHg (Procedure)
Increase of MAP at high target 80-85 mmHg (with catecholamines or volemic expansion)
Target of mean arterial pressure (MAP) at 80-85 mmHg The therapeutic means used to obtain the MAP objectives within each group (increase in catecholamines and / or volume expansion) are left to the discretion of the clinician, in accordance with the recommendations.
干预措施: increase of mean arterial pressure at 80-85 mmHg (Procedure)
结局指标
主要结局
Changes of creatinine clearance
时间窗: At 6 hours and at 12 hours
Creatinine clearance is calculated with the formula UV/P as follow : * U being the urinary creatinine concentration in μmol/l * V the urinary volume expressed in ml per unit time * P the plasmatic creatinine concentration in μmol/l
次要结局
- Arterial hypertension treatment(At inclusion.)
- Introduction time of norepinephrine(At inclusion)
- Norepinephrine dose(At inclusion, then every hours up to hour 12)
- Number of days in intensive care unit(Day 90)
- Survival at day 90(Day 90)
- Co-morbidities(At inclusion.)
- Intra-vesical pression(At inclusion then every hour up to 12 hours.)
- Pulmonary compliance(At inclusion, at 6 hours and at 12 Hours.)
- Changes of renal resistive index(At 6 hours and 12 hours)
- Amount of fluids (unit = L )(At 6 hours and 12 hours)
- Quantity of nephrotoxic drugs(At inclusion, at 6 hours and 12 hours)
- Number of day with supportive care in intensive care unit (cathecolamines, renal replacement therapy, mechanical ventilation, extracorporeal membrane oxygenation)(Day 90)
- Number of days in hospital(Day 90)
- Tricuspid annular plane systolic excursion (TAPSE)(At inclusion, at 6 hours and at 12 hours.)
- Plateau pressure(At inclusion, at 6 hours and at 12 Hours.)
- End-expiratory pressure(At inclusion, at 6 hours and at 12 Hours.)
- paCO2(At inclusion, at 6 hours and at 12 hours.)
- Echocardiographic evaluation of left ventricular function(At inclusion, at 6 hours et at 12 hours)
- Cardiac index measured(At inclusion and every hour up to 12 hours.)
- Right S' wave(At inclusion, at 6 hours and at 12 hours.)
- Tidal volume(At inclusion, at 6 Horus and at 12 jours)
- Pulmonary pressions(At inclusion and every hour up to 12 hours)
- Collection of all adverse event(At 6 hours and at 12 hours.)
- paO2(At inclusion, at 6 hours and at 12 hours.)
- Continuous cardiac output(At inclusion and every hour up to 12 hours)
- Extra vascular lung water(At inclusion and every hour up to 12 hours)
- Pulmonary Vascular Permeability Indice(At inclusion and every hour up to 12 hours)
- Troponin(At inclusion, at 6 hours and at 12 hours.)
- Ionogram(At inclusion, at 6 hours and at 12 hours.)
- Lactates(At inclusion, at 6 hours and at 12 hours.)