drugset / Trial / NCT04071171

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

NCT04071171 ↗

Phase 2 Completed 88 enrolled Medical University Innsbruck
RandomizedCrossoverOpen-labelTreatment

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.

Timeline

Start
2020-08-01
Primary completion
2023-11-15
Completion
2024-03-11

Outcome

Met primary endpoint

paper LBF showed significantly lower rates of pH and HCO3- excursions compared to HBF PMID 41247497 ↗

paper Adjusted odds ratios were 1.78 (95% CI 1.12-2.82; p = 0.015) for pH and 3.60 (95% CI 2.16-5.99; p < 0.001) for HCO3-. PMID 41247497 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Biphozyl Unknown — —
Comparator Phoxilium Unknown — —

Indications