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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

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ClinicalTrials.gov Identifier: NCT04071171
Recruitment Status : Recruiting
First Posted : August 28, 2019
Last Update Posted : September 16, 2021
Sponsor:
Information provided by (Responsible Party):
Medical University Innsbruck

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
Critically Ill Acute Kidney Injury Renal Replacement Therapy Continuous Renal Replacement Therapy Continuous Veno-Venous Hemofiltration Replacement Fluid Phoxilium Biphozyl Anticoagulation Regional Citrate Anticoagulation Drug: CVVH with Phoxilium® in the first 48h after randomization Drug: CVVH with Biphozyl® in the first 48h after randomization Drug: CVVH with Phoxilium® in the second 48h after randomization (after previous 48h with Biphozyl®) Drug: CVVH with Biphozyl® in the second 48h after randomization (after previous 48h with Phoxilium®) 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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]
Actual Study Start Date : August 1, 2020
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Phoxilium® 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.

Experimental: Biphozyl® 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.




Primary Outcome Measures :
  1. pH [ Time Frame: 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.

  2. HCO3- [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04071171


Contacts
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Contact: Michael Joannidis, Univ.-Prof., MD +43 512 504 24180 michael.joannidis@i-med.ac.at

Locations
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Austria
Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Anichstrasse 35, 6020, Innsbruck, Austria Recruiting
Innsbruck, Tirol, Austria, 6020
Contact: Michael Joannidis, Univ.-Prof. MD    0043 512 504 24180    michael.joannidis@i-med.ac.at   
Sponsors and Collaborators
Medical University Innsbruck
Investigators
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Principal Investigator: Michael Joannidis, Univ.-Prof., MD Medical University Innsbruck
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Responsible Party: Medical University Innsbruck
ClinicalTrials.gov Identifier: NCT04071171    
Other Study ID Numbers: EudraCT No. 2019-001262-15
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: September 16, 2021
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Acute Kidney Injury
Critical Illness
Disease Attributes
Pathologic Processes
Renal Insufficiency
Kidney Diseases
Urologic Diseases