Temporal Changes in Plasma Lactate Concentration in Critically Ill Patients With Septic Shock Treated With Restrictive Compared to Standard Fluid Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 777
- 试验地点
- 1
- 主要终点
- Time to resolution of hyperlactemia
研究概览
简要总结
This study aim to examine if randomization to different treatment strategies had any effect on the time to normalization of lactate in intensive care patients treated for septic shock.
详细描述
This is a retrospective analysis of a subset of patients included in the Conservative versus Liberal Approach to fluid therapy of Septic Shock in Intensive Care (CLASSIC) trial.
In the CLASSIC trial patients with septic shock were randomized to either traditional (liberal) strategy for fluid treatment or a more conservative regimen. The study was an international multicenter clinical trial (clinicaltrials.gov NCT03668236), and results were published in New England Journal of Medicine in June 2022 (DOI: 10.1056/NEJMoa2202707).
In this substudy the investigator extract all lactate values for the study period from all patients included from Karolinska University Hospital, Sundsvall and Södersjukhuset (Sweden), participating centers on Zealand (Denmark), and Plzen University Hospital (Czech Republic). Baseline data, treatment allocation and amount of fluids administered are collected as well as outcome from CLASSIC study.
Primary outcome is time to lactate normalization (< 2mmol/L). Secondary outcome is lactate concentration over the first 72 hours (as peak lactate for the time intervals 0-3, 3-6, 6-12, 12-24 and then each 12h-period between 24 and 72 hours).
The subgroup with blood lactate > 4mmol/L will be analyzed separately for the same end points.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Investigator)
盲法说明
All patients are included and analyzed for outcomes in the CLASSIC trial. The allocation and amount of fluids received for the included subjects are blinded for the investigator at the time point of analysis.
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
- •Participation in CLASSIC trial in any of the participating centres
排除标准
- •Lack of sufficient data for analysis
研究组 & 干预措施
Conservative
Resuscitation fluids were only given under certain pre-defined criteria
干预措施: Resuscitation fluid (Drug)
结局指标
主要结局
Time to resolution of hyperlactemia
时间窗: 72 hours
Blood lactate \< 2.0 mmol/L
次要结局
- Temporal changes in lactate concentrations over time(72 hours)
研究者
Jonathan Grip
Principal Investigator, PhD
Karolinska University Hospital