Comparison of two substitution fluids (Biphozyl® and Phoxilium® ) during continuous renal replacement therapy in adult critically ill patients with acute kidney injury and their effects on acid-base status and respiratory situation. – A prospective, randomized, controlled, open, cross-over, Phase II, single-center pilot study

Phase 1

Conditions: Acute Kidney Injury (AKI). This is a A prospective, randomized, controlled, open, cross-over, Phase II, single-center pilot study to assess the effects of two different continuous veno-venous hemofiltration (CVVH) replacement fluids (Phoxilium® and Biphozyl®) in adult critically ill AKI patients treated with CVVH. Anticoagulation is delivered as pre-filter regional citrate anticoagulation with Regiocit® (Gambro Lundia AB, Sweden).
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

Registration Number: EUCTR2019-001262-15-AT

Lead Sponsor: Medical University Innsbruck

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 88

Inclusion Criteria

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

Exclusion Criteria

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)