Clinical trial NCT06766786: Magnesium Supplementation in Simultaneous Pancreas-Kidney Transplantation
Official title: Perioperative Magnesium Supplementation in Simultaneous Pancreas-Kidney Transplantation Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Failure Chronic Requiring Dialysis
Diabetes Mellitus, with Complications
Glomerulosclerosis
Pancreatic Insufficiency (Exocrine and Endocrine)
Transplantation, Kidney
Pancreas Transplantation
Keywords: SPK transplant
Simultaneous pancreas-kidney (SPK) transplant
Hypomagnesemia transplantation
Hypomagnesemia kidney transplant
Hypomagnesemia pancreas-kidney transplant
Hypomagnesemia simultaneous pancreas-kidney transplant
Lead sponsor: Salem Anaesthesia Pain Clinic
Sponsor class: OTHER
Collaborators: name: Central Manchester University Hospitals NHS Foundation Trust (co-sponsor, UK)
First posted: 2025-01-09
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cohort population of consecutive adult pancreatic-kidney failure patients on regular insulin and hemodialysis therapy and consenting to simultaneous pancreas-kidney (SPK) transplantation.

Brief summary: Magnesium is essential in human physiology. Simultaneous pancreas-kidney (SPK) transplant recipients frequently experience hypomagnesemia. The effects of hypomagnesaemia are harmful. This observational study assessed intraoperative magnesium supplementation's utility in patients undergoing SPK transplantation. Perioperative hemodynamics were monitored. Postoperative serum magnesium was monitored at 12 hours and 48 hours.

Detailed description: A vital component of human physiology is magnesium. It is common for recipients of simultaneous pancreas-kidney (SPK) transplants to have hypomagnesemia. The consequences of hypomagnesaemia are detrimental. This prospective observational study evaluated the effectiveness and safety of intraoperative magnesium supplementation in adult SPK transplant recipients. Arrhythmia and perioperative hemodynamics were observed. Serum magnesium levels were checked 12 and 48 hours after surgery.

Eligibility criteria: Inclusion Criteria:

* Adult diabetic patients who require insulin therapy and hemodialysis due to pancreatic-kidney failure.

Exclusion Criteria:

* Adult diabetic patients who do not require insulin therapy and hemodialysis.

Primary outcomes:
measure: Serum magnesium levels.
timeFrame: 48 hours
measure: Perioperative cardiovascular incidents.
timeFrame: 48 hours
Secondary outcomes:
measure: Postoperative neurological incidents.
timeFrame: 48 hours
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Central Manchester University Hospital
Study officials:
affiliation: Salem Anaesthesia Pain Clinic
name: Olumuyiwa Bamgbade, MD, FRCPC
role: STUDY_DIRECTOR
References:
citation: Bamgbade OA. Intraoperative magnesium supplementation improves gynecology major surgery perioperative outcome. J Clin Anesth. 2018 Feb;44:21. doi: 10.1016/j.jclinane.2017.10.019. No abstract available.