Magnesium Supplementation in Simultaneous Pancreas-Kidney Transplantation

Completed

• Conditions: Renal Failure Chronic Requiring Dialysis; Diabetes Mellitus, with Complications; Glomerulosclerosis; Pancreatic Insufficiency (Exocrine and Endocrine); Transplantation, Kidney; Pancreas Transplantation
• Interventions: Drug: Magnesium Sulfate high dose

• Registration Number: NCT06766786
• Lead Sponsor: Dr Olu Bamgbade, MD, FRCPC

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.

Study Timeline

• Study Start: 2008-01-02
• Primary Completion: 2020-02-20
• Study Completion: 2020-02-20
• Status Verified: 2025-01
• Study First Submitted: 2025-01-05
• Study First Submitted QC: 2025-01-05
• Last Update Submitted: 2025-01-05
• Study First Posted: 2025-01-09
• Last Update Posted: 2025-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Chronic pancreas-kidney failure.	Magnesium Sulfate high dose	Adult patients with diabetes mellitus and chronic pancreas-kidney failure who require insulin and hemodialysis therapy. Intravenous magnesium supplementation was given intraoperatively to consenting patients receiving simultaneous pancreas-kidney (SPK) transplantation.

Primary Outcome Measures

Name	Time	Method
Serum magnesium levels.	48 hours	Serum magnesium levels after surgery at 12 and 48 hours.
Perioperative cardiovascular incidents.	48 hours	Incidence rate of intraoperative and postoperative dysrhythmia events for each patient.

Secondary Outcome Measures

Name	Time	Method
Postoperative neurological incidents.	48 hours	Incidence rate of postoperative confusion, muscle spasms, or weakness in each patient.

Trial Locations

Locations (1)

Central Manchester University Hospital; 🇬🇧 Manchester, United Kingdom