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

• Status: Recruiting
• Trial end date: 2022-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University Innsbruck

Criteria

Inclusion Criteria:

1. Age ≥ 18 years

2. Admission to Intensive Care Unit

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

Exclusion Criteria:

1. Lack of commitment to provide CVVH 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 CVVH within the previous 72 hours

4. Dialysis dependent end-stage renal disease

5. Pregnancy, must be ruled out by anamnesis and/or blood or urine pregnancy test

6. Combination of severely impaired liver function and shock with muscle hypoperfusion

7. Co-enrollment in another trial, which could have a plausible interaction with the acid-base-status and/or any electrolytes

8. Subjects, who are legally exempted from participation in clinical trials (e.g. persons held in an institution by legal or official order)