"Low Flow" CO2 Removal Via a Membrane Gas Exchange Device (Prismalung®) on a Renal Replacement Platform (Prismaflex®) in Hypercapnic, Ventilated Patients Requiring Renal Replacement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Changes of the VT / plateau pressure in the ventilation (ventilation settings)
研究概览
简要总结
The purpose of this study is to test the effectiveness of a membrane gas exchange device in the venovenous circulation of a continuous renal replacement therapy for the purpose of CO2 elimination and pH compensation. Thus, the primary endpoint is the modification of the PaCO2 and/or the ventilator settings (tidal volume VT and plateau pressure Pplat).
详细描述
Protocol synopsis Study title "Low flow" CO2 removal via a membrane gas exchange device (Prismalung®) on a renal replacement platform (Prismaflex®) in hypercapnic, ventilated patients requiring renal replacement therapy Brief description Prismalung Study Indication Hypercapnic, ventilated, and renal replacement therapy requiring patients Primary study goal Changes in the arterial pCO2 value Secondary study goals Changes in the acid-base balance Changes of tidal volumes/ventilation pressures Changes in hemodynamics Study design Prospective intervention study (pilot study)
Study population Inclusion criteria:
- Necessity of renal replacement therapy
- Necessity of ventilation therapy with an expected duration >24 hrs. in mild to moderate ARDS according to the "Berlin Definition" (300≥PaO2/FiO2>100mmHg, ventilated acc. to the ARDS network strategy with VT 6 ml/kgKG (KG = Körpergewicht, body weight) and PEEP ≥ 5 cmH2O)Pneumonia, pulmonary vasculitis, COPD, or other pulmonary disorder
- PaCO2 ≥ 55 mmHg with plateau ventilation pressure > 25 cmH2O and pH < 7.30
- Written consent by patient or legal representative
Number of patients n = 20 Interventions 1. With ongoing continuous hemofiltration and mechanical ventilation additional membrane gas exchange device (Prismalung®) in the renal replacement circulation; measurements of the effects on PaCO2 under varying blood and sweep gas flows 2. Afterwards, reduction of the tidal volume (VT) / plateau pressure until reaching the initial PaCO2value Study drug None Primary endpoint 1. Changes in the PaCO2 / acid-base status (BGA) 2. Changes of the VT / plateau pressure in the ventilation (ventilation settings) Secondary endpoints Changes in the systemic hemodynamics Vasopressor dosage BGA, renal values, lactate PaCO2 before and after gas exchange device Lifetimes of the extracorporeal circulation Complications Study site Intensive care units Medizinische Klinik 4, Uniklinikum Erlangen-Nürnberg Medizinische Klinik 4, Klinikum Nürnberg Süd Klinik für Intensivmedizin Universitätsklinikum Hamburg Eppendorf Klinik für Anästhesiologie und Intensivmedizin Universitätsklinikum Frankfurt a. M. Timeline Start in October 2015 Anticipated study duration: 6 months Financing Baxter Gambro Renal GmbH (Ltd)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Necessity of renal replacement therapy
- •Necessity of ventilation therapy with an expected duration >24 hrs. in mild to moderate ARDS according to the "Berlin Definition" (300≥PaO2/FiO2>100mmHg, ventilated acc. to the ARDS network strategy with VT 6 ml/kgKG (KG = Körpergewicht, body weight) and PEEP ≥ 5 cmH2O) Pneumonia, pulmonary vasculitis, COPD, or other pulmonary disorder
- •PaCO2 ≥ 55 mmHg with plateau ventilation pressure > 25 cmH2O and pH < 7.30
- •Written consent by patient or legal representative
排除标准
- •Age < 18 years
- •BMI > 40 kg/m2
- •Decompensated heart failure or acute stroke
- •Severe ARDS (PaO2/FiO2 < 100 mmHg)
- •Acute cranio-cerebral injury
- •Severe liver failure (Child-Pugh score >7)
- •Heparin-induced thrombopenia (HIT II)
- •Contraindications to the performance of CVVH (continuous venovenous hemofiltration)
- •Contraindications to systemic anticoagulation
- •Lacking possibility of access via a dialysis catheter
- •Surgeries scheduled within 48 hrs of inclusion in the study
- •Advanced tumor disorder with life expectancy < 1 month
- •Moribund patients, decision to forego therapy
- •Lacking consent
- •Participation in a different intervention study
研究组 & 干预措施
CO2 removal
干预措施: Extracorporeal CO2 removal with the Prismalung(R) gas exchanger on the Prismaflex(R) renal replacement platform (Device)
结局指标
主要结局
Changes of the VT / plateau pressure in the ventilation (ventilation settings)
时间窗: hours to 3 days
Changes in the PaCO2, acid-base status (BGA)
时间窗: hours to 3 days
次要结局
- Changes in heart rate (bpm)(hours to 3 days)
- Changes in norepinephrin dose (mg/h)(hours to 3 days)
- Changes in Serum lactate concentration (mmol/l)(hours to 3 days)
- Arterial bicarbonate concentration (mmol/l)(hours to 3 days)
- Changes in mean arterial pressure (mmHg)(hours to 3 days)
- Arterial pO2 and pCO2 (mmHg)(hours to 3 days)
- PCO2 before and after gas exchange device (mmHg)(hours to 3 days)
- Number and kind of adverse events during study period deemed clinically significant by investigator (as documented by paper questionnaire)(hours to 3 days)
- Standard Base Excess (mmol/l)(hours to 3 days)
- Changes in Serum creatinine (mg/dl)(hours to 3 days)
- Lifetime of extracorporeal circuit in hours (Duration from start to end of RRT)(hours to 3 days)
研究者
stefan john
Prof. Dr. med. Stefan John
University of Erlangen-Nürnberg Medical School