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临床试验/NCT05525936
NCT05525936尚未招募不适用

Characterization and Definition of Right Ventricular Injury in Patients Admitted to Intensive Care: Prospective Observational Study

Assistance Publique - Hôpitaux de Paris0 个研究点目标入组 440 人开始时间: 2024年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
440
主要终点
Classification performance of selected haemodynamic parameters, ventilation parameters and biomarkers in different types of right ventricular injuries

研究概览

简要总结

The adequate characterization of RV injury is currently unknown. The hypothesis is that the best characterization of RV injury is the one with the most significant impact on the response to fluids and on the outcome. An RV failure is expected to induce fluid-unresponsiveness and potentially worst outcome.

The main objective is to characterize different types of RV injury in critically ill patients by examining their association, including predictive performances, in hemodynamics parameters, ventilation parameters, and clinical outcomes

The study will be based on the realisation of an echocardiography within 48 hours following inclusion.

详细描述

Rationale Injury of the right ventricle (RV) is common in patients admitted to intensive care and impacts management and prognosis. Echocardiography has become the cornerstone of diagnosis and management of such an impairment. However, the many studies using echocardiography already published use different approaches to characterize and define "RV injury" making it difficult to accurately assess its incidence and prognostic impact. Briefly, 3 approaches are proposed. The first is based on a more cardiological approach that consists of using parameters of the RV systolic function, and defines the injury as these parameters estimates are below certain threshold. The most commonly used parameters are TAPSE, fractional area change, and Doppler velocity of the systolic (S') wave at the tricuspid annulus. The second approach is based on the pattern of cor pulmonale, defining RV injury as the presence of RV dilatation and paradoxical septal motion. The third approach is to define RV injury according to its consequences on upstream congestion (kidney, liver for example). This is probably the most physiological approach. It is thus defined as the association of an RV dilation with an abnormally high central venous pressure (CVP).

The hypothesis is that the best definition of RV injury is the one that will be best associated with hemodynamic status (e.g. the lack of response to volume expansion or its equivalent such as passive leg raising, PLR), ventilation and oxygenation parameters and with clinical outcomes, including mortality (ICU or in-hospital), duration of invasive ventilation (in ventilated patients), ICU length of stay and duration of catecholamine infusion.

All patients will receive a transthoracic (TTE) or a transesophageal (TEE) echocardiography according to the usual practice of the center and the patient's situation. A standard TTE or TEE echocardiography will be performed within 48 hours of inclusion (Echo-1), and another TTE or TEE (Echo-2) for fluid responsiveness study immediately after Echo-1.

The following information will be recorded

  1. Patients characteristics (at admission and/or at inclusion) Date of ICU admission, date of inclusion, age, gender, past history of hypertension, diabetes mellitus, ischemic heart disease, cardiomyopathy of any cause, chronic kidney disease, COPD (chronic obstructive pulmonar disease), chronic PH (pulmonary hypertension), height, size (BMI), SAPS II, "primary" inclusion (within 2 days following admission) or "secondary" inclusion (during ICU stay), admission diagnosis: sepsis, septic shock, acute exacerbation of COPD, pulmonary embolism, acute asthma, drug poisoning, brain injury, myocardial infarction, pneumonia, COVID-19, miscellaneous.
  2. Hemodynamic status (at the time of echo) Heart rate, sinus rhythm (Y/N), blood pressure (systolic, diastolic, mean), pulse pressure variations, PPV (if available), CVP (or RAP if PAC), serum lactate, base deficit, type of catecholamine and dose (in µg/kg/min), VA ECMO (yes/no).
  3. Renal, liver function and biomarkers (at the time of echo or the closest to the study) Creatinine, ASAT, ALAT, bilirubin, platelets, troponin, BNP (if available)
  4. Blood gas analysis (at the time of echo or the closest to the study) PaO2, PaO2/FiO2, PaCO2, pH, SaO2.
  5. Ventilatory settings and oxygen delivery (at the time of echo)

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

入选标准

  • Patients admitted to intensive care unit
  • With a central venous catheter inserted in the superior vena cava territory or a pulmonary arterial catheter for their management,
  • Requiring invasive ventilation, and/or catecholamine infusion.

排除标准

  • Advanced chronic heart failure,
  • Planned or unplanned surgery including cardiac,
  • Advanced cancer,
  • Child C cirrhosis,
  • Contraindication to PLR and volume expansion,
  • Age < 18 years,
  • Pregnancy.

结局指标

主要结局

Classification performance of selected haemodynamic parameters, ventilation parameters and biomarkers in different types of right ventricular injuries

时间窗: Through study completion, an average of 1 year.

Comparisons of classification performance for each model using a composite classification metrics consisting of R2, prediction accuracies, AUC and F1 scores.

Association of the three different types of RV injury with ICU mortality

时间窗: Through study completion, an average of 1 year

Odds ratios

次要结局

  • The cutoff values of TAPSE, FAC and S' that best predict clinical outcomes(Through study completion, an average of 1 year)
  • Prediction performance of three types of RV injury for fluid responsiveness.(Through study completion, an average of 1 year)
  • Percentage of the 3 types of RV injuries(Through study completion, an average of 1 year)
  • Differentiating fluid responders from non-responders using different combinations of RV/LV EDA and CVP(Through study completion, an average of 1 year)
  • Prediction power of the three types of RV injury for clinical outcomes.(Through study completion, an average of 1 year)
  • Clinical factors associated with RV injury in an unselected population of critically-ill patients.(Through study completion, an average of 1 year)

研究者

申办方类型
Other
责任方
Sponsor

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