Comparison of Biphozyl® and Phoxilium® as a replacement fluid during Continuous Veno-Venous Hemofiltration (CVVH) with Regional Citrate Anticoagulation (RCA) for Acute Kidney Injury (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

Medical University Innsbruck0 个研究点目标入组 88 人开始时间: 2020年1月23日最近更新: 2024年4月29日

适应症

试验速览

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•To be eligible for enrollment in the BiPhox-trial, a subject must fulfill all of the inclusion criteria and none of the exclusion criteria below:
•1. Age = 18 years (male & female & diverse)
•2. Admission to Intensive Care Unit (ICU)
•3. Indication for CVVH as determined by the attending physician
•4. Planned CVVH treatment time = 48 hours
•5. Written informed consent or deferred consent or legally acceptable representative consent
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 30
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 58

•1. Lack of commitment to provide RRT as part of limitation of ongoing life support
•2. Presence of a drug overdose that may result in acid-base-disorders and/or a shift of electrolytes
•3. Receipt of RRT within the previous 72 hours
•4. Dialysis dependent end-stage renal disease (ESRD)
•5. Pregnancy
•6. Combination of severely impaired liver function and shock with muscle hypoperfusion
•7. Co-enrollment in another clinical trial
•8. Subjects, who are legally exempted from participation in clinical trials (e.g. persons held in an institution by legal or official order)

发起方

Medical University Innsbruck