ASSESSment of Peripheral Perfusion, Tissue Oxygen Saturation, Endothelial Function and Coagulation Disorder in Circulatory SHOCK, the ASSESS - SHOCK Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 325
- 试验地点
- 3
- 主要终点
- Average severity of Organ dysfunction during the first 7 days in the ICU (study period)
研究概览
简要总结
The objective of the observational cohort study is (1) to deduce whether measurements of peripheral near-infrared spectroscopy (NIRS) (lower limb) associate with the development of organ dysfunction as assessed by daily Sequential Orfgan Failure Score (SOFA) in the Intensive Care Unit (ICU), (2)whether cerebral (frontal) tissue haemoglobin oxygen saturation (StO2) values are associated with delirium in the ICU and (3) the association of frontal and peripheral StO2 with other micro- and macrohemodynamic parameters in this patient group , (4) to deduce the associations between shock, endotheliopathy, disseminated intravascular coagulation (DIC) and tissue perfusion and, last, the feasibility of central and peripheral NIRS monitoring in shock patients in the ICU using the Medtronic INVOS NIRS StO2 appliances. In addition, the investigators target to evaluate (5) the incidence, evolution, and outcome of sepsis-associated DIC, and (6) the associations between a) continuous hemodynamic data, b) laboratory data (such as syndecan-1 (SDC-1), vascular adhesion protein 1 (VAP1), CD73, heparin binding protein (HBP), endostatin, chromogranin, mitochondrial function tests,blood count d-dimer, international normalized ratio (INR), neuron specific enolase and metabolomics data) (7) and study associations of singlenucleotide polymorphisms with developing organ dysfunction and 90-day mortality. To compare the hemodynamic alterations of burn patients to septic patients with the intention to find new ways to monitor and manage hemodynamic and particularly microcirculation in burn patients.
详细描述
Background:
Circulatory shock is a frequent condition in the intensive care unit, comprising roughly one of three patients in the intensive care unit (ICU), and associated with high mortality rates. Current treatment guidelines state that one of the main goals for therapeutic interventions is to improve tissue perfusion to prevent subsequent organ dysfunction and death. In acute critical illness, up to one fourth of the patients develop severe hemostatic aberrations and coagulopathy, called disseminated intravascular coagulation (DIC), which is associated with excess mortality.
Despite differences in the underlying cause, acutely critically ill patients share similar features that may be driven by shock. This response, potentially escalating to life-threatening conditions, is relatively homogenous. The shock induced sympatho-adrenal hyperactivation may be a critical driver this endotheliopathy. If allowed to proceed uncontrollably, damages to the microcirculation and organ dysfunction may follow.
Near-infrared spectroscopy (NIRS), a non-invasive method based on the principles of light transmission and absorption, offers a non-invasive and continuous bedside method to assess tissue haemoglobin oxygen saturation (StO2), which may serve as an indirect measure of the adequacy of tissue perfusion. NIRS could potentially be used for early identification of patients with tissue hypoperfusion and therefore high risk of developing organ dysfunction, and may also be used for assessing frontal cerebral oxygen saturation in circulatory failure and its use is well documented in general anaesthesia in many patient groups. There are some data showing an association between low frontal StO2 values and delirium in the ICU. The use of near-infrared spectroscopy to measure tissue oxygenation in healthy humans has been well validated. However, assessing tissue oxygenation using NIRS in critically ill patients is less well established. The hemodynamic and other systemic responses in burns are similar to those in septic shock. However, the mechanisms behind these responses have not been compared between burn and septic shock patients to our knowledge. Overall, the knowledge of microcirculation and how to monitor it in burn patients is limited.
Objectives:
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 Critically ill patients requiring Intensive Care Unit (ICU) care with circulatory shock within 4 hours (≤ hours) of ICU admission or with circulatory shock developing in the ICU within 24 hours from ICU admission and within 4 hours of initiation of vasopressor treatment presenting with the below listed signs of for circulatory shock
- •Hypotension - need for vasopressor to achieve mean arterial pressure (MAP) ≥65 mmHg after 1L of crystalloid solution
- •Any sign of hypoperfusion (at least one of the signs below)
- •blood lactate ≥2 mmol/L
- •mottling score ≥ 2
- •Base Excess (BE) ≤ - 5 mEq/L
- •prolonged capillary refill time ≥ 2 s
- •cool periphery beyond elbows or knees bilaterally
- •altered mentation
- •Confirmed or suspected infection and anti-microbial treatment
- •OR as an independent criteria for the ASSESS-SHOCK BURNS substudy
- •Burn injury ≥30% total body surface area(TBSA), ICU admission within 12h of the injury, with or without hypotension and signs of hypoperfusion within 4 hours of ICU admission
排除标准
- •Age < 18 years
- •Pregnant or lactating
- •Known refusal to any clinical study or this specific study
- •Consent not obtained (according to local regulatory statements for ethical conduct of research)
- •Out-of-hospital cardiac arrest (OHCA) patients
- •Terminal illness and not considered for full intensive care support
- •Planned postoperative admission
- •Postoperative intensive care after organ transplantation
- •Patients who are likely to be transferred to the ward in 24 hours
- •Defects of skin, underlying tissues or extremities preventing the use of the central or peripheral NIRS probes (the first 250 enrolled patients)
结局指标
主要结局
Average severity of Organ dysfunction during the first 7 days in the ICU (study period)
时间窗: First week in the Intensive Care Unit after admission
Average Sequential Organ Failure Assessment (SOFA) during days 1 to day 7 in the ICU, higher SOFA score indicates greater severity of organ failure, the total SOFA score ranges from 0-24 points
90-day mortality
时间窗: 90 days
Death within 90 days from ICU admission
Change in severity of Organ dysfunction during the first week in ICU (study period)
时间窗: At 7 days in ICU
Change in the total Sequential Organ Failure Assessment (SOFA) score from day 1 to day 7 in the ICU, higher SOFA score indicates greater severity of organ failure, the total SOFA score ranges from 0-24 points
New organ dysfunctions
时间窗: First week in the Intensive Care Unit after admission
Number of new organ dysfunctions (new organ dysfunction defined as one of 6 SOFA subscores ≥3 points/ total 4 points, higher points indicate greater severity. Only one new organ dysfunction / each subscore can be used for calculation of total number of new organ dysfunctions in one week
次要结局
- INVOS NIRS feasibility and safety questionnaire(0-48 hours in Intensive Care Unit after enrolment into study)
- Days without vasoactive medication in 28 days(28 days)
- Intensive care delirium severity(First week in the Intensive Care Unit after admission)
- Intensive care delirium scoring checklist aggregate and average score during first week in intensive care(First week in the Intensive Care Unit after admission)
- Days without RRT in 28 days(28 days)
- Days off ventilator in 28 days(28 days)
- ICU length of stay(90 days)
- Intensive care delirium incidence(First week in the Intensive Care Unit after admission)
- Time to Extubation(28 days)
- 28-day mortality(28 days)
- Cognitive dysfunction after ICU discharge(6 months)
研究者
Erika Wilkman, MD PhD
Doctor, Adjunct Professor
Helsinki University Central Hospital