Prediction of Arterial Lactate and Blood Gas Values Through the Analysis of Central Venous Blood. A Human, Prospective, Multicenter Validation Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 398
- 试验地点
- 10
- 主要终点
- Percentage error rate when predicting arterial values (pH, PaCO2, SaO2 and lactate) from central venous values.
研究概览
简要总结
Predicting arterial lactate and blood gas values with sufficient accuracy by simply analyzing central venous blood would be interesting in intensive care unit patients in whom the insertion of an arterial catheter or arterial punctures could be avoided. This prospective study aims at externally validating published mathematical models built to predict arterial values from central venous blood analysis.
详细描述
Mathematical models for predicting arterial blood gas and arterial lactate have recently be published (PMID 27543529; see the citations section). The aim of the study is to externally validate these models in a multicenter (11 centres in France) cohort of intensive care unit patients suffering from acute circulatory failure. For the peru pose of the study, patients will undergo concomitent central venous/arterial blood sampling from 1 to 4 times during their intensive cafe unit stay. Clinical characteristics of the patients and central venous blood gas and lactate values will be used to predicted arterial values according to previously published formula. Predicted and actual arterial values of each variable of interest (pH, PaCO2, SaO2, lactate) will then be compared.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •age>18 years
- •patient admitted in a intensive care unit
- •patient already carrying an indwelling arterial catheter and a superior vena cava central catheter
- •patient presenting an acute circulatory failure defined by the presence of at least two of the following items: a) Persistent hypotension (systolic arterial blood pressure < 90 mm Hg or mean arterial pressure < 65 mm Hg) or need for continuous intravenous vasopressor treatment (at any dose). b) Presence of at least one of the following signs of hypoperfusionfusion :Change in mental status ; Skin mottling ; Oliguria (Urine output <0.5 ml/kg body weight for at least one hour); Arterial lactate > 2 mmol/l or peripheral venous lactate > 3.2 mmol/l; ScvO2 <70%.
- •Routine medical management requires central venous blood sampling for ScvO2 measurement and arterial blood sampling for gazometry.
排除标准
- •Opposition to participation in the study
- •Impossibility to take a concomitant arterial and venous gazometric sample.
- •Patient treated with ECMO (extracorporeal membrane,oxygrnation), intermittent dialysis or continuous dialysis during sampling
- •Patient hospitalized without consent and/or deprived of liberty by court decision.
结局指标
主要结局
Percentage error rate when predicting arterial values (pH, PaCO2, SaO2 and lactate) from central venous values.
时间窗: 15 minutes
For each variable of interest (pH, PaCO2, SaO2 and lactate), the percentage of predicted values outside the agreement interval obtained in a previously published study (i.e., -0.078 to +0.084 for arterial pH; -1.32 to +1.36 kPa for PaCO2; -5.15 to +4.47% for SaO2; 1.07 to +1.05 mmol/l for arterial lactate) will be calculated.
次要结局
- Bias and agreement interval between predicted and actual arterial values for each variable of interest.(15 minutes)