Continuous Central Venous Oxygen Saturation Measurement as a Tool to Predict Hemodynamic Instability Related to Renal Replacement Therapy in Critically Ill Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Venous oxygen saturation measurement
研究概览
简要总结
Acute kidney injury (AKI) is common in intensive care unit (ICU) and inducing a high morbidity and mortality. In severe forms of AKI (more than 25% of AKI patients admitted to the ICU), renal replacement therapy (RRT) is often necessary. Although RRT is a cornerstone of therapy, it can lead to serious adverse effects, such as intradialytic arterial hypotension. Indeed, arterial hypotension during the session - intra-dialytic arterial hypotension (IDH) - occurs frequently complication and so regardless of the RRT modality used. Its occurrence may worsen significantly the outcome as previously reported. It is therefore of parmount importance to prevent such an adverse effect.
The investigators hypothesize that a decrease in the central venous oxygen saturation (SvcO2) measured related to a decreased cardiac output could precede the onset of IDH. The aim of this study is collect IDH in AKI patients and to measure continuously SvcO2 during RRT session in order to investigate its role in predicting IDH.
详细描述
In ICU settings, about 25% of AKI patients underwent RRT. RRT leads to certain complications, the most frequent and severe of which is IDH. The frequency of IDH varies from 10 to 70% and from 19 to 43% in intermittent and continuous RRT respectively.
The occurrence of IDH worsens the prognosis of critically ill patients. It may impair the recovery of renal function and is associated with increased mortality. Thus, early detection of IDH requires the development of preventive strategies and the implementation of adapted curative therapies.
IDH results from several mechanisms. The main mechanisms involved is hypovolemia leading to cardiac dysfunction, but also cardiac dysfunction not related to hypovolemia.
The identification of tools correlated with cardiac output could allow early prediction of IDH. Yet, no tool has been evaluated to predict the occurrence of IDH.
Central venous oxygen saturation (SvcO2) is a reflection of the balance between systemic O2 transport and tissue O2 consumption and thus is the indicator of cardiac output. A decrease in cardiac output leads to a decrease in SvcO2 to enhance O2 transport and to maintain arterial pressure. Assuming that O2 extraction is constant, SvcO2 would then be a surrogate for cardiac output. A decrease in SvcO2 may reflect a decrease in cardiac output before IDH occurs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •Critically ill patients requiring blood pressure monitoring
- •Severe AKI treated by RRT
- •Hemodynamic stability prior to initiation of RRT
- •Patients aged above 18 years
排除标准
- •Pregnancy
- •Major under tutorship or curatorship
- •Refusal of the patient or trusted person/family (if present) to sign the informed consent or to confirm participation in the case of emergency inclusion
- •Patient is not beneficiary or affiliated with a social security plan
- •Contraindication to placement of a venous catheter in the superior vena cava territory: thrombosis of the superior vena cava, thrombosis of the jugular and subclavian veins
- •Chronic end-stage renal failure on chronic dialysis
结局指标
主要结局
Venous oxygen saturation measurement
时间窗: 1-28 days
Venous oxygen saturation measured continuously during the RRT session in the critically ill patient. Intradialytic hypotension is defined as the occurrence of a decrease in systolic blood pressure below 90mmHg and/or a decrease in mean arterial pressure below 65mmHg that warrants therapeutic intervention (vascular filling, introduction or increase in the dose of vasopressor by more than 25% to maintain satisfactory blood pressure, discontinuation of ultrafiltration) during the RRT session.
次要结局
- Number of IDH during a RRT session(1-28 days)
- IDH corrective measures(1-28 days)
- Cardiac output variation(1-28 days)
- Pulse pressure variation(1-28 days)
- RRT duration(1-28 days)
- Mortality in the ICU(1-28 days)