Targeted Tissue Perfusion Versus Macrocirculatory-guided Standard Care in Patients With Septic Shock [TARTARE-2S]- A Multicentre Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 3
- 主要终点
- Days alive in 30 days- without vasopressors/ inotropes or hyperlactatemia
研究概览
简要总结
Background: The recommended monitoring and target levels in septic shock (SSC Guidelines 2012) including mean arterial pressure (MAP) target are not based on robust clinical data.
Objective: To test, if in patients with septic shock, tissue perfusion guided (TPG) treatment strategy leads to a faster resolution of hypoperfusion than the macrocirculatory target guided standard care.
Design: A prospective phase II two-parallel-group open-label randomized controlled trial
Interventions:
- Intervention group- Targeted tissue perfusion guided (TTP) - care.
- Control group - Macrocirculatory - guided (MCG) care.
Randomization: 1:1 stratified according to the site and presence or absence of known hypertension.
Trial size: 200 randomised patients in 4 ICUs.
详细描述
Study hypothesis: Targeting at clinical tissue perfusion (in the TTP arm) will decrease the use and untoward effects of vasopressors, and result in more days alive in 30-days without vasopressor or inotropic support and without lactatemia, in comparison with standard clinical care with preference of macrocirculatory targets (MCG arm).
Intervention group - Targeted tissue perfusion (TTP) care:
Primary targets /registration period
- capillary refill time (CRT) / <3 sec/ every hour
- skin mottling / absent / every hour
- arterial lactate / <2.0 mmol/l/ per 2hr
- peripheral temperature/ warm /every hour
- urine output/ ≥0.5 mL/kg per hour/ every hour
- mean arterial pressure (MAP) 50-65 mmHg (minimum as a safety limit)/ continuous
- if previous hypertension 65- 70 mmHg
- if oliguria 2-hour trial 75-80 mmHg (If diuresis better, continue 2hr and re-evaluate) Secondary target
- Continuous mixed venous saturation (SvO2) >65%, if available
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Septic shock defined as
- •Septic infection AND
- •systemic mean blood pressure > 65 mmHg requiring any dose of vasopressors (norepinephrine, vasopressin) despite adequate fluid resuscitation (minimum of 20 ml/kg crystalloids) AND
- •Elevated lactate ≥ 3.0 mmol/L with suspected hypoperfusion
排除标准
- •aged less than 18 or over 80 years
- •any other probable condition than sepsis affecting or expected to affect the central nervous system including post cardiac arrest
- •present or suspected myocardial ischemia
- •acute pulmonary embolism
- •terminal illness and not considered for full intensive care support
- •use of extra-corporeal membrane oxygenation (ECMO)
- •known liver disease - Child-Pugh -Class B or C
- •confirmed chronic kidney disease known on admission
- •known to be pregnant or lactating
- •more than 4 hours from fulfilled inclusion criteria to randomization
- •another probable cause of hyperlactatemia
- •patients transferred from another ICU
- •patients with active haematological malignancy
结局指标
主要结局
Days alive in 30 days- without vasopressors/ inotropes or hyperlactatemia
时间窗: 30 days
• Days alive in 30 days with normal arterial blood lactate ( first confirmed value of \< 2 mmol/L) AND without any inotropic or vasopressor agent
次要结局
- Days alive outside hospital in 90 days(90 days)
- Time to normalization of arterial blood lactate(30 days)
- Days alive with normal arterial blood lactate in 30 days(30 days)
- Days alive without mechanical ventilation in 30 days(30 days)
- Days alive without any inotropic or vasopressor agent in 30 days(30 days)
- Days alive without any organ support (mechanical ventilation, renal-replacement therapy, vasopressor/ inotropic agents) in 30 days(30 days)
- Days alive without renal replacement therapy (RRT) in 30 days(30 days)
- Number/ total number of the following adverse reactions(30 days)
- New acute kidney injury (AKI) (Kdigo stages I-III)(30 days)
- Total amount of norepinephrine given up to day 5(5 days)
研究者
Ville Pettilä
Professor of Intensive Care Medicine
Helsinki University Central Hospital