NCT06302192尚未招募不适用
RED-AKI: Renal Doppler in Acute Kidney Injury. Capability of Intrarenal Venous Flow Doppler (IRVF) to Predict Acute Kidney Injury (AKI) in Critically Ill Patients With Acute Respiratory Distress Syndrome (ARDS)
Policlinico Hospital0 个研究点目标入组 164 人开始时间: 2024年4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
- 发起方
- 入组人数
- 164
- 主要终点
- cumulative incidence
研究概览
简要总结
This is a multicenter international observational prospective cohort study. The main questions it aims to answer are:
- PRIMARY AIM: To describe the capability of IRVF demodulation at diagnosis of ARDS to predict development of AKI within 7 days from the ARDS onset
- SECONDARY AIMS: A)Describe the capability of IRVF demodulation or pattern of IRVF (continuous, pulsatility, biphasic, monophasic) to predict development of AKI within 14 days from the ARDS onset. B) To describe the RD parameters and VexUS in the AKI and no AKI patients over time. C) Describe the impact of invasive mechanical ventilation (IMV) on the intrarenal venous congestion and VexUS., D) Evaluation of effect of CRRT on IRVF pattern, VexUS and parameters. E) Describe the feasibility of renal doppler to assess IRVF in critically ill respiratory patients. F) Evaluate the incidence of AKD and CKD Participants will Adult patients with diagnosis of ARDS admitted to intensive care unit and undergoing invasive mechanical ventilation
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 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •Critically ill patients admitted to intensive care unit with a diagnosis of ARDS according to Berlino criteria
- •Beginning of IMV less than 48 hours or Clinical decision to begin IMV.
- •Life expectancy > 24 hours
- •Informed consent signed
排除标准
- •No patient will be excluded from the study because of gender, race, ethnicity, or sexual preference.
- •AKI prior to the onset of ARDS
- •Chronic respiratory failure due to chronic respiratory diseases
- •Chronic renal disease (CKD stage ≥ 2) and any ureteral obstruction. Definition of CKD patient is according to the latest guideline KDIGO
- •Chronic Heart Failure
- •Chronic liver disease
- •Major trauma in the past 3 months
- •Major surgery in the past 3 months
- •Smoking and Alcohol drinking
- •Patients needing of VV-ECMO and VA-ECMO
- •Beginning of positive pressure ventilation more than 48 hours (invasive or no invasive)
- •Life expectancy <24 hours
- •Cardio Circulatory Arrest
- •Neoplasm in chemotherapy/radiotherapy
- •Do Not Resuscitate or Comfort Measures
- •Pregnancy at ICU admission
- •Refused Informed Consent by the patient or surrogate decision-maker
结局指标
主要结局
cumulative incidence
时间窗: 1st april 2024 - 31st of january 2026
Cumulative incidence of AKI within 7 days from the ARDS onset in demodulated and no-demodulated group
次要结局
- AKIstage(1st april 2024 - 31st of january 2026)
- CKD progression(1st april 2024 - 31st of january 2026)
- cross talk lung-kidney(1st april 2024 - 31st of january 2026)
- CRRT(1st april 2024 - 31st of january 2026)
- incidence of failed exam(1st april 2024 - 31st of january 2026)
- AKI14(1st april 2024 - 31st of january 2026)
研究者
Giacomo Grasselli
Professor
Policlinico Hospital
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