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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-01

Study Completion Date

2024-03-11

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy and Safety of a Citrate-based Anticoagulation With Calcium-free Phosphate-containing Fluid in Renal Replacement Therapy

NCT04215965

Critical Care

UNKNOWN PHASE4

Fluid Balance Guided by Modified Venous Excess Ultrasonography Versus Standard Care in Patients With Acute Kidney Injury Receiving Continuous Renal Replacement Therapy

NCT07346118

AKI - Acute Kidney Injury Fluid Balance Acute Circulatory Failure +4 more

NOT_YET_RECRUITING NA

Fluid-removal Guided by VeXUS Score With Usual Care in Patients With Acute Kidney Injury After Cardiac Surgery

NCT06251713

Acute Kidney Injury Cardiac Surgery Venous Congestion +1 more

RECRUITING NA

Sodium Bicarbonate for the Treatment of Severe Metabolic Acidosis With Moderate or Severe Acute Kidney Injury in ICU

NCT04010630

Metabolic Acidosis Acute Kidney Injury

COMPLETED NA

VExUS-guided Fluid Management in the ICU

NCT07291778

Acute Kidney Injury VExUS

NOT_YET_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Critically Ill Acute Kidney Injury Renal Replacement Therapy Continuous Renal Replacement Therapy Continuous Veno-Venous Hemofiltration Replacement Fluid Phoxilium Biphozyl Anticoagulation Regional Citrate Anticoagulation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Phoxilium®

Group Type ACTIVE_COMPARATOR

CVVH with Phoxilium® in the first 48h after randomization

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

Intervention Type 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.

Biphozyl®

Group Type EXPERIMENTAL

CVVH with Biphozyl® in the first 48h after randomization

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

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No