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
Study Details
Study Description
Brief 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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 2 |
Detailed Description
After being fully eligible by meeting all inclusion and none of the exclusion criteria, participants will be randomly assigned to one of two groups, either the Phoxilium® - Group or Biphozyl® - Group. After randomization, patients receive either Phoxilium® or Biphozyl® for CVVH initiation and maintenance as a replacement fluid during the first 48 hours (h) of treatment. After the first 48h of CVVH with either Phoxilium® or Biphozyl® a cross-over follows, with another 48h of CVVH with the opposite replacement fluid (Phoxilium® switched to Biphozyl® or Biphozyl® switched to Phoxilium®). In comparison, all patients should receive one session of CVVH with 96h. Resulting from 48h of CVVH with Phoxilium® and 48h of CVVH with Biphozyl® as a replacement fluid. The order is determined by randomization.
Anticoagulation is always 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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Active Comparator: Phoxilium®
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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 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.
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Experimental: Biphozyl®
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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 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.
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Outcome Measures
Primary Outcome Measures
- pH [96 hours (48h of CVVH with Phoxilium® vs. 48h of CVVH with Biphozyl®)]
Rate of pH excursions from a set range of 7.35-7.45.
- HCO3- [96 hours (48h of CVVH with Phoxilium® vs. 48h of CVVH with Biphozyl®)]
Rate of HCO3- excursions from a set range of 22-26 mmol/l.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age ≥ 18 years
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Admission to Intensive Care Unit
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Indication for CVVH as determined by the attending physician
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Planned CVVH treatment time ≥ 48 hours
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Written informed consent or deferred consent or legally acceptable representative consent
Exclusion Criteria:
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Lack of commitment to provide CVVH as part of limitation of ongoing life support
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Presence of a drug overdose that may result in acid-base-disorders and/or a shift of electrolytes
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Receipt of CVVH within the previous 72 hours
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Dialysis dependent end-stage renal disease
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Pregnancy, must be ruled out by anamnesis and/or blood or urine pregnancy test
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Combination of severely impaired liver function and shock with muscle hypoperfusion
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Co-enrollment in another trial, which could have a plausible interaction with the acid-base-status and/or any electrolytes
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Subjects, who are legally exempted from participation in clinical trials (e.g. persons held in an institution by legal or official order)
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Anichstrasse 35, 6020, Innsbruck, Austria | Innsbruck | Tirol | Austria | 6020 |
Sponsors and Collaborators
- Medical University Innsbruck
Investigators
- Principal Investigator: Michael Joannidis, Univ.-Prof., MD, Medical University Innsbruck
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- EudraCT No. 2019-001262-15