Acute Kidney Injury Clinical Trial
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]
Verified date | March 2024 |
Source | Medical University Innsbruck |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 88 |
Est. completion date | March 11, 2024 |
Est. primary completion date | November 15, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 120 Years |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
Austria | Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Anichstrasse 35, 6020, Innsbruck, Austria | Innsbruck | Tirol |
Lead Sponsor | Collaborator |
---|---|
Medical University Innsbruck |
Austria,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | pH | Rate of pH excursions from a set range of 7.35-7.45. | 96 hours (48h of CVVH with Phoxilium® vs. 48h of CVVH with Biphozyl®) | |
Primary | HCO3- | Rate of HCO3- excursions from a set range of 22-26 mmol/l. | 96 hours (48h of CVVH with Phoxilium® vs. 48h of CVVH with Biphozyl®) |
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