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 | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

August 1, 2020

Primary Completion Date

November 15, 2023

Study Completion Date

March 11, 2024

Conditions

Critically IllAcute Kidney InjuryRenal Replacement TherapyContinuous Renal Replacement TherapyContinuous Veno-Venous HemofiltrationReplacement FluidPhoxiliumBiphozylAnticoagulationRegional Citrate Anticoagulation

Interventions

DRUG

CVVH with Phoxilium® in the first 48h after randomization

After randomization into the Phoxilium®-group, CVVH will be initiated with Phoxilium® as a replacement fluid and maintained for 48h, respectively until the crossover. Anticoagulation is 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.

DRUG

CVVH with Biphozyl® in the first 48h after randomization

After randomization into the Biphozyl®-group, CVVH will be initiated with Biphozyl® as a replacement fluid and maintained for 48h, respectively until the crossover. Anticoagulation is 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.

DRUG

CVVH with Phoxilium® in the second 48h after randomization (after previous 48h with Biphozyl®)

48h post randomization, respectively after the cross-over CVVH will be continued with Phoxilium® for another 48h. Anticoagulation is 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.

DRUG

CVVH with Biphozyl® in the second 48h after randomization (after previous 48h with Phoxilium®)

48h post randomization, respectively after the cross-over CVVH will be continued with Biphozyl® for another 48h. Anticoagulation is 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.

Trial Locations (1)

6020

Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Anichstrasse 35, 6020, Innsbruck, Austria, Innsbruck

All Listed Sponsors

lead

Medical University Innsbruck

OTHER