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Magnesium Kinetics During Citrate-Anticoagulated CRRT

2026. november 6. frissítette: Region Skane

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:

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.

A tanulmány áttekintése

Állapot

Még nincs toborzás

Körülmények

Beavatkozás / kezelés

Egyéb: Serial blood and dialysis circuit fluid sampling

Részletes leírás

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.

Tanulmány típusa

Megfigyelő

Beiratkozás (Becsült)

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi kapcsolat

Név: Marcus Ewert Broman
Telefonszám: +46 70 289 84 25
E-mail: marcus.broman@med.lu.se

Tanulmányozza a kapcsolattartók biztonsági mentését

Név: Eyrun Arna Kristinsdottir
Telefonszám: +46 76 560 88 01
E-mail: eyrun.kristinsdottir@skane.se

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

18 év és régebbi (Felnőtt, Idősebb felnőtt)

Egészséges önkénteseket fogad

Nem

Tanulmányozható nemek

Összes

Mintavételi módszer

Nem valószínűségi minta

Tanulmányi populáció

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.

Leírás

Inclusion Criteria:

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.

Exclusion Criteria:

- None beyond failure to meet the inclusion criteria.

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

Megfigyelési modellek: COHORT
Időperspektívák: PROSPECTIVE

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő	Intézkedés leírása	Időkeret
Changes in systemic total magnesium concentration Időkeret: Before CRRT initiation (baseline) and at 2, 6, 12, 18, 24, 48, and 72 hours after initiation.	Changes in systemic total magnesium concentration (mmol/L), measured using conventional clinical laboratory methods, will be assessed from baseline and over time during continuous renal replacement therapy with regional citrate anticoagulation.	Before CRRT initiation (baseline) and at 2, 6, 12, 18, 24, 48, and 72 hours after initiation.
Changes in systemic ionized magnesium concentration Időkeret: Before CRRT initiation (baseline) and at 2, 6, 12, 18, 24, 48, and 72 hours after initiation.	Changes in systemic ionized magnesium concentration (mmol/L), measured using ion-selective electrode technology, will be assessed from baseline and over time during continuous renal replacement therapy with regional citrate anticoagulation.	Before CRRT initiation (baseline) and at 2, 6, 12, 18, 24, 48, and 72 hours after initiation.
Citrate-associated changes in magnesium ionization Időkeret: At 2, 6, 12, 18, 24, 48, and 72 hours after CRRT initiation.	Changes in the ionized magnesium fraction (ionized magnesium/total magnesium) between systemic and pre-filter blood will be assessed following administration of citrate-containing predilution fluid, accounting for dilution. Ionized magnesium will be measured using ion-selective electrode technology and total magnesium using conventional clinical laboratory methods.	At 2, 6, 12, 18, 24, 48, and 72 hours after CRRT initiation.
Magnesium flux across the extracorporeal filter Időkeret: At 2, 6, 12, 18, 24, 48, and 72 hours after CRRT initiation.	Magnesium flux across the extracorporeal filter (mmol/h) will be calculated using total and ionized magnesium concentrations in pre-filter and post-filter blood and effluent fluid, accounting for blood flow rates, treatment fluid flow rates and fluid composition. Ionized magnesium will be measured using ion-selective electrode technology and total magnesium using conventional clinical laboratory methods.	At 2, 6, 12, 18, 24, 48, and 72 hours after CRRT initiation.
Net magnesium loss attributable to CRRT Időkeret: At 2, 6, 12, 18, 24, 48, and 72 hours after CRRT initiation.	Net magnesium loss attributable to CRRT (mmol/h) will be calculated from magnesium removal in the effluent, accounting for magnesium supplied through dialysate and post-filter replacement fluids. Calculations will use the actual treatment fluid composition and flow rates at each sampling time. Ionized magnesium will be measured using ion-selective electrode technology and total magnesium using conventional clinical laboratory methods.	At 2, 6, 12, 18, 24, 48, and 72 hours after CRRT initiation.

Másodlagos eredményintézkedések

Eredménymérő	Intézkedés leírása	Időkeret
Changes in systemic total calcium concentration Időkeret: Before CRRT initiation (baseline) and at 2, 6, 12, 18, 24, 48, and 72 hours after initiation.	Changes in systemic total calcium concentration (mmol/L), measured using conventional clinical laboratory methods, will be assessed from baseline and over time during continuous renal replacement therapy with regional citrate anticoagulation.	Before CRRT initiation (baseline) and at 2, 6, 12, 18, 24, 48, and 72 hours after initiation.
Changes in systemic ionized calcium concentration Időkeret: Before CRRT initiation (baseline) and at 2, 6, 12, 18, 24, 48, and 72 hours after initiation.	Changes in systemic ionized calcium concentration (mmol/L), measured using ion-selective electrode technology, will be assessed from baseline and over time during continuous renal replacement therapy with regional citrate anticoagulation.	Before CRRT initiation (baseline) and at 2, 6, 12, 18, 24, 48, and 72 hours after initiation.
Calcium flux across the extracorporeal filter Időkeret: At 2, 6, 12, 18, 24, 48, and 72 hours after CRRT initiation.	Calcium flux across the extracorporeal filter (mmol/h) will be calculated using total and ionized calcium concentrations in pre-filter and post-filter blood and effluent fluid, accounting for blood flow rates, treatment fluid flow rates and fluid composition. Ionized calcium will be measured using ion-selective electrode technology and total calcium using conventional clinical laboratory methods.	At 2, 6, 12, 18, 24, 48, and 72 hours after CRRT initiation.
Net calcium loss attributable to CRRT Időkeret: At 2, 6, 12, 18, 24, 48, and 72 hours after CRRT initiation.	Net calcium loss attributable to CRRT (mmol/h) will be calculated from calcium removal in the effluent, accounting for calcium supplied through dialysate and post-filter replacement fluids. Calculations will use the actual treatment fluid composition and flow rates at each sampling time. Ionized calcium will be measured using ion-selective electrode technology and total calcium using conventional clinical laboratory methods.	At 2, 6, 12, 18, 24, 48, and 72 hours after CRRT initiation.
Changes in systemic phosphate concentration Időkeret: Before CRRT initiation (baseline) and at 2, 6, 12, 18, 24, 48, and 72 hours after initiation.	Changes in systemic phosphate concentration (mmol/L), measured using conventional clinical laboratory methods, will be assessed from baseline and over time during continuous renal replacement therapy with regional citrate anticoagulation.	Before CRRT initiation (baseline) and at 2, 6, 12, 18, 24, 48, and 72 hours after initiation.
Phosphate flux across the extracorporeal filter Időkeret: At 2, 6, 12, 18, 24, 48, and 72 hours after CRRT initiation.	Net phosphate flux across the extracorporeal filter (mmol/h) will be calculated using phosphate concentrations measured by conventional clinical laboratory methods in pre-filter and post-filter blood and effluent fluid, accounting for blood and treatment fluid flow rates and fluid composition.	At 2, 6, 12, 18, 24, 48, and 72 hours after CRRT initiation.
Net phosphate loss attributable to CRRT Időkeret: At 2, 6, 12, 18, 24, 48, and 72 hours after CRRT initiation.	Net phosphate loss attributable to CRRT (mmol/h) will be calculated using phosphate concentrations measured in effluent fluid by conventional clinical laboratory methods, accounting for phosphate supplied through dialysate and replacement fluids. Calculations will use the actual treatment fluid composition and flow rates at each sampling time.	At 2, 6, 12, 18, 24, 48, and 72 hours after CRRT initiation.
Changes in systemic blood pH during RCA-CRRT Időkeret: Before CRRT initiation (baseline) and at 2, 6, 12, 18, 24, 48, and 72 hours after initiation.	Changes in systemic arterial blood pH will be assessed from baseline and over time during continuous renal replacement therapy with regional citrate anticoagulation, using arterial blood gas analysis.	Before CRRT initiation (baseline) and at 2, 6, 12, 18, 24, 48, and 72 hours after initiation.
Changes in systemic bicarbonate concentration during RCA-CRRT Időkeret: Before CRRT initiation (baseline) and at 2, 6, 12, 18, 24, 48, and 72 hours after initiation.	Changes in systemic bicarbonate concentration (mmol/L) will be assessed from baseline and over time during continuous renal replacement therapy with regional citrate anticoagulation, using arterial blood gas analysis.	Before CRRT initiation (baseline) and at 2, 6, 12, 18, 24, 48, and 72 hours after initiation.
Changes in systemic base excess during RCA-CRRT Időkeret: Before CRRT initiation (baseline) and at 2, 6, 12, 18, 24, 48, and 72 hours after initiation.	Changes in systemic base excess (mmol/L) will be assessed from baseline and over time during continuous renal replacement therapy with regional citrate anticoagulation, using arterial blood gas analysis.	Before CRRT initiation (baseline) and at 2, 6, 12, 18, 24, 48, and 72 hours after initiation.

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Szponzor

Region Skane

Együttműködők

Nova Biomedical

Vantive Health LLC

Nyomozók

Kutatásvezető: Marcus Ewert Broman, Skåne University Hospital, Lund University

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete (Becsült)

2026. november 1.

Elsődleges befejezés (Becsült)

2027. október 1.

A tanulmány befejezése (Becsült)

2028. január 1.

Tanulmányi regisztráció dátumai

Először benyújtva

2026. október 23.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak