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Completed

NCT Number: 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

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.

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Key information

Conditions

Critically Ill Acute Kidney Injury Anticoagulation Biphozyl Continuous Renal Replacement Therapy Continuous Veno-Venous Hemofiltration Critical Illness Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Phoxilium Regional Citrate Anticoagulation Renal Insufficiency Renal Replacement Therapy Replacement Fluid Urogenital Diseases Urologic Diseases

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Anichstrasse 35, 6020, Innsbruck, Austria

Innsbruck, Tyrol, 6020, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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)

Treatment and study plan

CVVH with Phoxilium® in the first 48h after randomization

Drug

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.

CVVH with Biphozyl® in the first 48h after randomization

Drug

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.

CVVH with Phoxilium® in the second 48h after randomization (after previous 48h with Biphozyl®)

Drug

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.

CVVH with Biphozyl® in the second 48h after randomization (after previous 48h with Phoxilium®)

Drug

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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Medical University Innsbruck

Other

Registry information

Official study 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]

Important dates

Study start
2020
Primary completion
2023
Study completion
2024
First posted
Aug 28, 2019
Registry last updated
Mar 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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