Status:
COMPLETED
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
Lead Sponsor:
Medical University Innsbruck
Conditions:
Critically Ill
Acute Kidney Injury
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
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 p...
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....
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Admission to Intensive Care Unit
- Indication for CVVH as determined by the attending physician
- Planned CVVH treatment time ≥ 48 hours
- Written informed consent or deferred consent or legally acceptable representative consent
Exclusion
- Lack of commitment to provide CVVH as part of limitation of ongoing life support
- Presence of a drug overdose that may result in acid-base-disorders and/or a shift of electrolytes
- Receipt of CVVH within the previous 72 hours
- Dialysis dependent end-stage renal disease
- Pregnancy, must be ruled out by anamnesis and/or blood or urine pregnancy test
- Combination of severely impaired liver function and shock with muscle hypoperfusion
- Co-enrollment in another trial, which could have a plausible interaction with the acid-base-status and/or any electrolytes
- Subjects, who are legally exempted from participation in clinical trials (e.g. persons held in an institution by legal or official order)
Key Trial Info
Start Date :
August 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 11 2024
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT04071171
Start Date
August 1 2020
End Date
March 11 2024
Last Update
March 13 2024
Active Locations (1)
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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, Tyrol, Austria, 6020