Clinical 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
Official title: 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 - A Prospective, Randomized, Controlled, Open, Cross-over, Phase II, Single-center Pilot Study [BiPhox-Trial]
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Critically Ill
Acute Kidney Injury
Renal Replacement Therapy
Continuous Renal Replacement Therapy
Continuous Veno-Venous Hemofiltration
Replacement Fluid
Phoxilium
Biphozyl
Anticoagulation
Regional Citrate Anticoagulation
Lead sponsor: Medical University Innsbruck
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Eligibility 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)

Primary outcomes:
measure: pH
timeFrame: 96 hours (48h of CVVH with Phoxilium® vs. 48h of CVVH with Biphozyl®)
measure: HCO3-
timeFrame: 96 hours (48h of CVVH with Phoxilium® vs. 48h of CVVH with Biphozyl®)
Secondary outcomes:
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Anichstrasse 35, 6020, Innsbruck, Austria
state: Tirol
Study officials:
affiliation: Medical University Innsbruck
name: Michael Joannidis, Univ.-Prof., MD
role: PRINCIPAL_INVESTIGATOR
References: