High-dose IV magnesium in mesothelioma patients receiving surgery with hyperthermic intraoperative cisplatin : Pilot studies and design of a phase II randomized clinical trial

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INTRODUCTION: Hyperthermic intraoperative cisplatin (HIOC) is associated with acute kidney injury (AKI). Administration of high-dose magnesium attenuates cisplatin-induced AKI (CP-AKI) in animal models but has not been rigorously examined in humans.

METHODS: We tested the feasibility and safety of different doses of magnesium in mesothelioma patients receiving HIOC. In Pilot Study 1, we administered a 36-h continuous infusion of magnesium at 0.5 g/h, targeting serum magnesium levels between 3 and 4.8 mg/dL. In Pilot Study 2A, we administered a 6 g bolus followed by an infusion starting at 2 g/h, titrated to achieve levels between 4 and 6 mg/dL. We eliminated the bolus in Pilot Study 2B.

RESULTS: In Pilot Study 1, all five patients enrolled completed the study; however, median postoperative Mg levels were only 2.4 mg/dL. In Pilot Study 2A, two of four patients (50%) were withdrawn due to bradycardia during the bolus. In Pilot Study 2B, two patients completed the study whereas two developed postoperative bradycardia attributed to the magnesium.

CONCLUSIONS: A 0.5 g/h infusion for 36 h did not achieve therapeutic magnesium levels, while an infusion at 2 g/h was associated with bradycardia. These studies informed the design of a randomized clinical trial testing whether intravenously Mg attenuates HIOC-associated AKI.

Medienart:

E-Artikel

Erscheinungsjahr:

2023

Erschienen:

2023

Enthalten in:

Zur Gesamtaufnahme - volume:128

Enthalten in:

Journal of surgical oncology - 128(2023), 7 vom: 19. Dez., Seite 1141-1149

Sprache:

Englisch

Beteiligte Personen:

Gupta, Shruti [VerfasserIn]
Wells, Sophia L [VerfasserIn]
Jose, Arunima M [VerfasserIn]
Seitter, Robert H [VerfasserIn]
Feghali, Lea [VerfasserIn]
Devaraj, Nishant [VerfasserIn]
Hartigan, Philip M [VerfasserIn]
Yacoubian, Stephanie [VerfasserIn]
Kwiatkowski, David J [VerfasserIn]
Burke, Donna M [VerfasserIn]
Barlow, Julianne [VerfasserIn]
Bueno, Raphael [VerfasserIn]
Leaf, David E [VerfasserIn]

Links:

Volltext

Themen:

Acute kidney injury
Cisplatin
Clinical Trial, Phase II
I38ZP9992A
Intraoperative chemotherapy
Journal Article
Magnesium
Mesothelioma
Q20Q21Q62J
Randomized Controlled Trial

Anmerkungen:

Date Completed 26.10.2023

Date Revised 10.02.2024

published: Print-Electronic

Citation Status MEDLINE

doi:

10.1002/jso.27412

funding:

Förderinstitution / Projekttitel:

PPN (Katalog-ID):

NLM361997310