Utility of the Mechanical Power (MP) of the ventilator versus Driving Pressure, Oxygenation, and Nutritional Evaluation (DRONE) score as a predictor of mortality, and non-resolving sub-phenotype of acute kidney injury (AKI) among ARDS patients: a prospective observational study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 137
- 试验地点
- 1
- 主要终点
- Mortality of the patient
研究概览
简要总结
After written informed consent from the legally authorized representatives, adult patients aged
18-90 years of either gender, diagnosed with ARDS on invasive mechanical ventilation will be
recruited for the study. The demographic parameters – age, gender, co-morbidities, APACHE II
score, SOFA score, lung ultrasound score, and KDIGO score will be noted.
On day 2 (24-48 hours) of ARDS diagnosis, the following will be noted:
- The DRONE score of the patients based on the worst value of Driving Pressure between
24-48 hours after ARDS diagnosis.
- The Mechanical Power (MP) of the ventilator – the highest MP recorded between 24-48
hours of ventilation will be noted.
On VCV, the MP of the ventilator will be calculated as:
(J/min)=0.098 * RR* Vt* (PEEP+1â„2 [P plat − PEEP]+[P peak – P plat])
MP = 0.098*RR*Vt *{Peak inspiratory pressure – 0.5 [P plateau-PEEP]
On PCV, the MP of the ventilator will be calculated as:
MP = 0.098*RR*Vt*{PEEP + ΔP insp}, where ΔPinsp is the pressure (cmH2O) above
PEEP during pressure-controlled ventilation.
- The serum creatinine levels will be determined from day 1, 3, 5, and the last day of ICU
stay of the ARDS patient.
- Standard of care investigations like complete blood picture, renal function tests, serum
electrolytes- sodium, potassium, C-reactive protein, procalcitonin, total bilirubin, albumin
and echocardiography parameters will be recorded.
- The worst lung ultrasound score will be recorded from the 12 lung regions bilaterally and
the highest renal arterial resistive index will be noted between 24-48 hours of ARDS
diagnosis.
- Need for renal replacement therapy, endotracheal, blood, urine, and pus culture reports,
need for prone ventilation, and net fluid balance at 48 hours of ARDS diagnosis will be
noted.
-
Days of ventilator support, ICU stay and mortality outcomes will be noted.
-
If the patient requires prone position ventilation due to severe ARDS, then the MP of the
ventilator will be noted before and after the prone position ventilation sessions. Primary- Mortality at 28 days from ARDS diagnosis.
Secondary- Need for RRT, non resolving AKI sub phenotype.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •ARDS as diagnosed by Berlin’s criteria.
排除标准
- •Patients with ARDS diagnosis more than 48 hours.
- •Patients of ARDS who are not on invasive mechanical ventilation (IMV).
- •Pregnant patients with ARDS.
- •Patients with known CKD or diagnosed CKD in hospital, where the AKI sub-phenotype based on creatinine trajectories will be unreliable.
- •Patients of pneumothorax where lung ultrasound score will be unreliable.
结局指标
主要结局
Mortality of the patient
时间窗: 28 days after ICU admission
次要结局
- Need for Renal Replacement Therapy due to Acute Kidney Injury.(7 days after ICU admission.)
研究者
Dr Pratik Paran Medhi
Kasturba Medical College,Manipal,Manipal Academy of Higher Education