Relation Between Mean Arterial Pressure and Renal Resistive Index in the Early Phase of Septic Shock
概览
- 阶段
- 不适用
- 干预措施
- increase of mean arterial pressure at 65-70 mmHg.
- 疾病 / 适应症
- Septic Shock
- 发起方
- University Hospital, Angers
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- changes of KDIGO stage
- 状态
- 已完成
- 最后更新
- 上个月
概览
简要总结
This study evaluates if improvement of renal resistive index when mean arterial pressure increase (at 65 mmHg to 85 mmHg) in early phase of septic shock is predictive of better renal survival.
详细描述
Learned societes (survival sepsis campaign and ESICM) are currently recommending a mean arterial pressure (MAP) target at 65 mmHg in septic shoc with a potential increase to 85 mmHg in patients with medical history of arterial hypertension. A high renal resistive index on the first day of septic shock was associated with acute renal failure more frequently on the 5th day. A decrease in the renal resistance index was also objectified during the increase in MAP. The main objective of this trial is to study the relationship between the improvement of the resistance index during a test of increase in average blood pressure during septic shock and the improvement of renal function In this interventional monocenter trial, we will measure the renal resistive index after stabilization of the MAP at 65 mmHg for two hours, then after 2 hours of stabilization at 85 mmHg. This part allows us to define the patients "responding" to the renal resistive index (improvement of the resitive renal index when the MAP increases). Then, patients will be randomized into two groups : * first group with a MAP target at 65 mmHg * second group with a MAP target at 85 mmHg. There will be a stratification on the responder character to the renal resistance index. Finally, we will assess renal function on the 7th day (with the assessment of serum creatinine and the change of stage of the KDIGO classification)
研究者
入排标准
入选标准
- •adult patients (≥ 18 ans)
- •Admitted to the intensive care unit of Angers with
- •arterial hypotension requiring the etablishment of catecholamines
- •In a context of proven or suspected sepsis, whaterver the cause of this infection.
- •norepinephrine dose ⩾ 0.1µg/kg/min
- •After 2 hours of stabilization at 65 mmHg of mean arterial pressure
排除标准
- •Pre-existing chronic renal failure (glomerular filtration rate \< 60 mL/min with MDRD)
- •Solitary kidney (anatomical or functional)
- •History of united or bilateral stenosis of the renal arteries
- •decision to stop or limit treatment
- •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 and oliguria/anuria \> 72 h.)
- •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
研究组 & 干预措施
low target group
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.
high target group
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.
结局指标
主要结局
changes of KDIGO stage
时间窗: Inclusion and day 7
modification of the KDIGO classification stage (estimated based on serum creatinine and diuresis) between the group with low target of mean arterial pressure ( 65-70 mmHg) and high target MAP (80-85 mmHg)
次要结局
- Renal resistive index(Inclusion, and 2 hours of mean arterial pressure stabilized at 85 mmHg and every day (day 1 to day 7))
- Collection of all adverse event(Day 1 to day 7)
- amount of fluids (unit = L or L/day)(Inclusion, day 1 to day 7)
- catecholamines free days(day 1 to day 7)
- extra renal replacement free days(Daily to day 1 to day 7, at day 28 and day 90)
- Number of day with supportive care in intensive care unit (renal replacement therapy, mechanical ventilation, extracorporeal membrane oxygenation)(Collection daily between Day 1 and Day 7, at Day 28.)
- Number of day in intensive care unit(Collection at Day 28 and Day 90)
- Number of day in hospital(Collection at Day 28 and Day 90)
- hemodynamic data collected by swan ganz or PICCO catheter(Inclusion and at 2 hours, daily between Day 1 and Day 7)
- quantity of nephrotoxic drugs(Inclusion and daily between Day 1 and Day 7.)
- serum creatinine (unit = µmol/L)(Inclusion and daily between Day 1 and Day 7)
- Diuresis (unit = mL per day)(Daily between day 1 and day 7)
- Survival at day 28(patient status (live or dead) at day 28)
- Survival at day 90(patient status (live or dead) at day 90)
- Skin recoloration time evolution(Inclusion and at 2 hours, daily between Day 1 and Day 7)