Comparison of Biphozyl® and Phoxilium® as a Replacement Fluid During CVVH for AKI in Adults and Their Effects on pH-, Bicarbonate-levels and Respiratory Situation - A Prospective, Randomized, Controlled, Open, Cross-over, Phase II, Single-center Pilot Study [BiPhox-Trial]
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- pH
研究概览
简要总结
The primary objectives of the BiPhox-Trial are to demonstrate, that the use of Biphozyl® as a replacement fluid in adult critically ill acute kidney injury (AKI) patients, results in a lower rate of pH excursions and of bicarbonate (HCO3-) excursions compared to the use of Phoxilium® during the studied continuous veno-venous hemofiltration (CVVH) interval with regional citrate anticoagulation (RCA).
The secondary objectives of the BiPhox-Trial are to evaluate the time to pH level normalization and the HCO3- substitution rates after initiation of CVVH treatment. Further, to demonstrate that the use of Biphozyl® as a replacement fluid in adult critically ill AKI patients, results in a more stable acid-base-status as well as improved respiratory situation due to lower intracorporeal HCO3- and carbon dioxide levels compared to the use of Phoxilium® during the studied CVVH interval with RCA.
详细描述
After being fully eligible by meeting all inclusion and none of the exclusion criteria, participants will be randomly assigned to one of two groups, either the Phoxilium® - Group or Biphozyl® - Group. After randomization, patients receive either Phoxilium® or Biphozyl® for CVVH initiation and maintenance as a replacement fluid during the first 48 hours (h) of treatment. After the first 48h of CVVH with either Phoxilium® or Biphozyl® a cross-over follows, with another 48h of CVVH with the opposite replacement fluid (Phoxilium® switched to Biphozyl® or Biphozyl® switched to Phoxilium®). In comparison, all patients should receive one session of CVVH with 96h. Resulting from 48h of CVVH with Phoxilium® and 48h of CVVH with Biphozyl® as a replacement fluid. The order is determined by randomization.
Anticoagulation is always delivered as pre-filter RCA with Regiocit® (Gambro Lundia AB, Sweden). For antagonisation of Regiocit®, a calcium solution (calcium chloride, with or without magnesium chloride) will be used post-filter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Admission to Intensive Care Unit
- •Indication for CVVH as determined by the attending physician
- •Planned CVVH treatment time ≥ 48 hours
- •Written informed consent or deferred consent or legally acceptable representative consent
排除标准
- •Lack of commitment to provide CVVH as part of limitation of ongoing life support
- •Presence of a drug overdose that may result in acid-base-disorders and/or a shift of electrolytes
- •Receipt of CVVH within the previous 72 hours
- •Dialysis dependent end-stage renal disease
- •Pregnancy, must be ruled out by anamnesis and/or blood or urine pregnancy test
- •Combination of severely impaired liver function and shock with muscle hypoperfusion
- •Co-enrollment in another trial, which could have a plausible interaction with the acid-base-status and/or any electrolytes
- •Subjects, who are legally exempted from participation in clinical trials (e.g. persons held in an institution by legal or official order)
研究组 & 干预措施
Phoxilium®
干预措施: CVVH with Phoxilium® in the first 48h after randomization (Drug)
Phoxilium®
干预措施: CVVH with Phoxilium® in the second 48h after randomization (after previous 48h with Biphozyl®) (Drug)
Biphozyl®
干预措施: CVVH with Biphozyl® in the first 48h after randomization (Drug)
Biphozyl®
干预措施: CVVH with Biphozyl® in the second 48h after randomization (after previous 48h with Phoxilium®) (Drug)
结局指标
主要结局
pH
时间窗: 96 hours (48h of CVVH with Phoxilium® vs. 48h of CVVH with Biphozyl®)
Rate of pH excursions from a set range of 7.35-7.45.
HCO3-
时间窗: 96 hours (48h of CVVH with Phoxilium® vs. 48h of CVVH with Biphozyl®)
Rate of HCO3- excursions from a set range of 22-26 mmol/l.
次要结局
未报告次要终点