An observational study in Continuous Renal Replacement Therapy (CRRT) and Magnesium, sponsored by Region Skane. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by Region Skane · Observational
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.
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.
Region Skane is the lead sponsor of 386 studies on the registry; 122 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
obtained in accordance with the approved study procedures.
Exclusion Criteria:
None beyond failure to meet the inclusion criteria.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Before CRRT initiation (baseline) and at 2, 6, 12, 18, 24, 48, and 72 hours after initiation.
Calcium kinetics during RCA-CRRT
Changes in systemic total and ionized calcium concentrations, extracorporeal calcium flux and calcium mass balance.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 24, 48, and 72 hours for scheduled metabolic sampling
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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