Continuous Renal Replacement Therapy (CRRT)NCT07906340
Magnesium Kinetics During Citrate-Anticoagulated CRRT
An observational study of Continuous Renal Replacement Therapy (CRRT) and Magnesium, run by Region Skane.
Trial summary
The goal of this observational study is to assess how continuous renal replacement therapy (CRRT), a type of dialysis used in critically ill patients, affects magnesium levels in adults treated in intensive care units (ICUs). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Continuous Renal Replacement Therapy (CRRT), Magnesium
- What is being tested?
- Serial blood and dialysis circuit fluid sampling
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of adult patients (≥18 years) admitted to the intensive care units (ICUs) at Skåne University Hospital in Sweden and Landspitali University Hospital in Iceland, for whom a clinical decision has been made to initiate continuous renal replacement therapy (CRRT) with regional citrate anticoagulation (RCA). Eligible patients will be those scheduled to receive continuous veno-venous hemodiafiltration (CVVHDF) using the PrisMax system and an ST150 hemofilter as part of routine clinical care.
Who may be able to join
- Age ≥18 years. Clinical decision to initiate continuous renal replacement therapy (CRRT) with regional citrate anticoagulation (RCA).
- Planned treatment with continuous veno-venous hemodiafiltration (CVVHDF) using the PrisMax system and an ST150 hemofilter.
- Informed consent obtained in accordance with the approved study procedures.
Who cannot join
- None beyond failure to meet the inclusion criteria.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Total and Ionized Magnesium Kinetics During Citrate-Anticoagulated Continuous Renal Replacement Therapy
The goal of this observational study is to assess how continuous renal replacement therapy (CRRT), a type of dialysis used in critically ill patients, affects magnesium levels in adults treated in intensive care units (ICUs). The study focuses on CRRT using citrate, a substance that prevents blood clotting in the dialysis circuit. Participants will receive CRRT with citrate as part of their routine medical care.
The main questions it aims to answer are:
Read more
How does citrate affect the amount of free (ionized) magnesium in the blood How much magnesium is removed by the dialysis circuit during treatment? How do magnesium levels in the blood change over time during treatment? How does treatment affect calcium and phosphate levels and what changes occur in the body's acid-base balance and metabolism?
Researchers will:
Measure magnesium, calcium and phosphate levels in blood and dialysis circuit fluid samples collected before and during treatment, for up to 72 hours.
Measure additional blood markers to assess changes in metabolism and acid-base balance.
Record dialysis treatment settings and fluid flow rates.
The collected measurements will be used to better understand how magnesium and other electrolytes are affected during CRRT with citrate.
Read the detailed description
Regional citrate anticoagulation (RCA) is frequently used during continuous renal replacement therapy (CRRT) to prevent blood clotting within the extracorporeal circuit. Citrate works by binding ionized calcium, thereby inhibiting the coagulation cascade. However, citrate also binds ionized magnesium, which may affect magnesium levels and contribute to magnesium losses during treatment. Previous studies have reported magnesium losses during CRRT with RCA but most have focused on total magnesium concentrations. The effects of citrate on ionized magnesium, the biologically active fraction of magnesium, remain less well understood.
The primary objective of this prospective observational study is to characterize magnesium kinetics during CRRT with RCA by repeated measurements of both total and ionized magnesium concentrations in the patient's blood and at different locations within the extracorporeal circuit. The study will investigate citrate-associated magnesium binding, magnesium transport across the dialysis filter, magnesium mass balance within the circuit and changes in systemic magnesium concentrations over time.
Secondary objectives are to characterize calcium and phosphate kinetics during treatment and to explore associated changes in acid-base balance and metabolic parameters.
Approximately 35 adult patients receiving CRRT with RCA as part of routine clinical care at three intensive care units (ICUs), one in Sweden and two in Iceland. Eligible patients will be those receiving continuous veno-venous hemodiafiltration (CVVHDF) using the PrisMax system and an ST150 hemofilter. All treatment decisions, including citrate administration, dialysis settings, and fluid management, will follow routine clinical practice and will not be altered by the study. Study-specific sampling will continue for up to 72 hours or until the ongoing CRRT circuit is discontinued, whichever occurs first.
Blood samples will be collected before treatment initiation and at 2, 6, 12, 18, 24, 48, and 72 hours after treatment begins. Systemic blood samples will be obtained from the patient's arterial line, while additional samples will be collected from the pre-filter and post-filter blood sampling ports and from the effluent fluid of the extracorporeal circuit. Total and ionized magnesium and calcium concentrations, as well as phosphate concentrations, will be measured to assess changes over time and calculate electrolyte transport and balance within the circuit. Additional systemic blood measurements will be performed before treatment and at 24, 48, and 72 hours to assess metabolic and acid-base responses. Dialysis treatment parameters, such as blood flow, citrate dose, treatment fluid flow rates and fluid removal, will also be recorded.
By combining repeated measurements of total and ionized magnesium with measurements across the extracorporeal circuit, this study aims to improve understanding of magnesium handling during CRRT with RCA. The findings may help determine whether monitoring total magnesium alone adequately reflects changes in ionized magnesium and provide further insight into electrolyte and metabolic changes during treatment.
- Being tested
- Serial blood and dialysis circuit fluid sampling
- Keywords
- Regional Citrate Anticoagulation, Continuous Renal Replacement Therapy, Magnesium, Ionized Magnesium, Magnesium kinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serial blood and dialysis circuit fluid samplingOther
Additional blood and dialysis circuit fluid samples will be collected at predefined time points for up to 72 hours to measure magnesium, calcium, phosphate and metabolic parameters. CRRT treatment will be provided according to routine clinical practice and will not be modified by the study.
What is being measured
The primary outcome is the main question the study is designed to answer.
Citrate-associated magnesium chelation
Citrate-associated magnesium chelation will be assessed using differences in total and ionized magnesium concentrations between systemic and pre-filter blood, accounting for the flow rate and composition of the pre-filter replacement fluid.
Measured: At 2, 6, 12, 18, 24, 48, and 72 hours after CRRT initiation.
Magnesium flux across the extracorporeal filter
Magnesium flux across the filter will be calculated using magnesium concentrations in pre-filter and post-filter blood and effluent fluid, accounting for blood flow rates, treatment fluid flow rates and fluid composition.
Measured: At 2, 6, 12, 18, 24, 48, and 72 hours after CRRT initiation.
Extracorporeal magnesium mass balance
Magnesium mass balance within the extracorporeal circuit will be calculated from magnesium concentrations in pre-filter and post-filter blood and effluent fluid, accounting for blood and treatment fluid flow rates and treatment fluid composition.
Measured: At 2, 6, 12, 18, 24, 48, and 72 hours after CRRT initiation.
Changes in systemic total and ionized magnesium concentrations
Changes in systemic total and ionized magnesium concentrations will be assessed from baseline and over time during CRRT with regional citrate anticoagulation.
Measured: Before CRRT initiation (baseline) and at 2, 6, 12, 18, 24, 48, and 72 hours after initiation.
Secondary outcomes (3)
Calcium kinetics during RCA-CRRT
Changes in systemic total and ionized calcium concentrations, extracorporeal calcium flux and calcium mass balance.
Measured: Baseline and up to 72 hours, according to the sampling schedule
Phosphate kinetics during RCA-CRRT
Changes in systemic phosphate concentrations, extracorporeal phosphate flux and phosphate mass balance.
Measured: Baseline and up to 72 hours, according to the sampling schedule
Metabolic and acid-base responses during RCA-CRRT
Changes in metabolic and acid-base parameters and their associations during treatment.
Measured: Baseline, 24, 48, and 72 hours for scheduled metabolic sampling
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Continuous Renal Replacement Therapy (CRRT)Studies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Collaborators
- Nova Biomedical, Vantive Health LLC
- Responsible party
- Sponsor
- Investigators
- Marcus Ewert Broman, Principal investigator, Skåne University Hospital, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07906340
- Sponsor's protocol ID
- Dnr 2025-08131-01
- Status last verified
- Sep 2026
- First submitted
- 23 Oct 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total and Ionized Magnesium Kinetics During Citrate-Anticoagulated Continuous Renal Replacement Therapy
- ClinicalTrials.gov ID
- NCT07906340
- Acronym / sponsor ID
- Dnr 2025-08131-01
- Keywords
- Regional Citrate Anticoagulation, Continuous Renal Replacement Therapy, Magnesium, Ionized Magnesium, Magnesium kinetics
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Collaborators
- Nova Biomedical, Vantive Health LLC
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 30 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to assess how continuous renal replacement therapy (CRRT), a type of dialysis used in critically ill patients, affects magnesium levels in adults treated in intensive care units (ICUs). The study focuses on CRRT using citrate, a substance that prevents blood clotting in the dialysis circuit. Participants will receive CRRT with citrate as part of their routine medical care.
The main questions it aims to answer are:
How does citrate affect the amount of free (ionized) magnesium in the blood How much magnesium is removed by the dialysis circuit during treatment? How do magnesium levels in the blood change over time during treatment? How does treatment affect calcium and phosphate levels and what changes occur in the body's acid-base balance and metabolism?
Researchers will:
Measure magnesium, calcium and phosphate levels in blood and dialysis circuit fluid samples collected before and during treatment, for up to 72 hours.
Measure additional blood markers to assess changes in metabolism and acid-base balance.
Record dialysis treatment settings and fluid flow rates.
The collected measurements will be used to better understand how magnesium and other electrolytes are affected during CRRT with citrate.
Detailed description
Regional citrate anticoagulation (RCA) is frequently used during continuous renal replacement therapy (CRRT) to prevent blood clotting within the extracorporeal circuit. Citrate works by binding ionized calcium, thereby inhibiting the coagulation cascade. However, citrate also binds ionized magnesium, which may affect magnesium levels and contribute to magnesium losses during treatment. Previous studies have reported magnesium losses during CRRT with RCA but most have focused on total magnesium concentrations. The effects of citrate on ionized magnesium, the biologically active fraction of magnesium, remain less well understood.
The primary objective of this prospective observational study is to characterize magnesium kinetics during CRRT with RCA by repeated measurements of both total and ionized magnesium concentrations in the patient's blood and at different locations within the extracorporeal circuit. The study will investigate citrate-associated magnesium binding, magnesium transport across the dialysis filter, magnesium mass balance within the circuit and changes in systemic magnesium concentrations over time.
Secondary objectives are to characterize calcium and phosphate kinetics during treatment and to explore associated changes in acid-base balance and metabolic parameters.
Approximately 35 adult patients receiving CRRT with RCA as part of routine clinical care at three intensive care units (ICUs), one in Sweden and two in Iceland. Eligible patients will be those receiving continuous veno-venous hemodiafiltration (CVVHDF) using the PrisMax system and an ST150 hemofilter. All treatment decisions, including citrate administration, dialysis settings, and fluid management, will follow routine clinical practice and will not be altered by the study. Study-specific sampling will continue for up to 72 hours or until the ongoing CRRT circuit is discontinued, whichever occurs first.
Blood samples will be collected before treatment initiation and at 2, 6, 12, 18, 24, 48, and 72 hours after treatment begins. Systemic blood samples will be obtained from the patient's arterial line, while additional samples will be collected from the pre-filter and post-filter blood sampling ports and from the effluent fluid of the extracorporeal circuit. Total and ionized magnesium and calcium concentrations, as well as phosphate concentrations, will be measured to assess changes over time and calculate electrolyte transport and balance within the circuit. Additional systemic blood measurements will be performed before treatment and at 24, 48, and 72 hours to assess metabolic and acid-base responses. Dialysis treatment parameters, such as blood flow, citrate dose, treatment fluid flow rates and fluid removal, will also be recorded.
By combining repeated measurements of total and ionized magnesium with measurements across the extracorporeal circuit, this study aims to improve understanding of magnesium handling during CRRT with RCA. The findings may help determine whether monitoring total magnesium alone adequately reflects changes in ionized magnesium and provide further insight into electrolyte and metabolic changes during treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of adult patients (≥18 years) admitted to the intensive care units (ICUs) at Skåne University Hospital in Sweden and Landspitali University Hospital in Iceland, for whom a clinical decision has been made to initiate continuous renal replacement therapy (CRRT) with regional citrate anticoagulation (RCA). Eligible patients will be those scheduled to receive continuous veno-venous hemodiafiltration (CVVHDF) using the PrisMax system and an ST150 hemofilter as part of routine clinical care.
Key inclusion criteria (3 listed)
- Age ≥18 years. Clinical decision to initiate continuous renal replacement therapy (CRRT) with regional citrate anticoagulation (RCA).
- Planned treatment with continuous veno-venous hemodiafiltration (CVVHDF) using the PrisMax system and an ST150 hemofilter.
- Informed consent obtained in accordance with the approved study procedures.
Key exclusion criteria (1 listed)
- None beyond failure to meet the inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serial blood and dialysis circuit fluid samplingAdditional blood and dialysis circuit fluid samples will be collected at predefined time points for up to 72 hours to measure magnesium, calcium, phosphate and metabolic parameters. CRRT treatment will be provided according to routine clinical practice and will not be modified by the study. | Other | – |
Primary outcome
Citrate-associated magnesium chelation
Time frame: At 2, 6, 12, 18, 24, 48, and 72 hours after CRRT initiation.
Citrate-associated magnesium chelation will be assessed using differences in total and ionized magnesium concentrations between systemic and pre-filter blood, accounting for the flow rate and composition of the pre-filter replacement fluid.
Magnesium flux across the extracorporeal filter
Time frame: At 2, 6, 12, 18, 24, 48, and 72 hours after CRRT initiation.
Magnesium flux across the filter will be calculated using magnesium concentrations in pre-filter and post-filter blood and effluent fluid, accounting for blood flow rates, treatment fluid flow rates and fluid composition.
Extracorporeal magnesium mass balance
Time frame: At 2, 6, 12, 18, 24, 48, and 72 hours after CRRT initiation.
Magnesium mass balance within the extracorporeal circuit will be calculated from magnesium concentrations in pre-filter and post-filter blood and effluent fluid, accounting for blood and treatment fluid flow rates and treatment fluid composition.
Changes in systemic total and ionized magnesium concentrations
Time frame: Before CRRT initiation (baseline) and at 2, 6, 12, 18, 24, 48, and 72 hours after initiation.
Changes in systemic total and ionized magnesium concentrations will be assessed from baseline and over time during CRRT with regional citrate anticoagulation.
3 secondary outcomes
Calcium kinetics during RCA-CRRT
Time frame: Baseline and up to 72 hours, according to the sampling schedule
Phosphate kinetics during RCA-CRRT
Time frame: Baseline and up to 72 hours, according to the sampling schedule
Metabolic and acid-base responses during RCA-CRRT
Time frame: Baseline, 24, 48, and 72 hours for scheduled metabolic sampling
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marcus Ewert Broman principal investigator
Skåne University Hospital, Lund University
Questions about this trial
What is this clinical trial studying?
An observational study of Continuous Renal Replacement Therapy (CRRT) and Magnesium, run by Region Skane.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marcus Ewert Broman (+46 70 289 84 25, marcus.broman@med.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Citrate-associated magnesium chelation (time frame: At 2, 6, 12, 18, 24, 48, and 72 hours after CRRT initiation.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.