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NCT Number: NCT06766786

Magnesium Supplementation in Simultaneous Pancreas-Kidney Transplantation

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.

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Key information

Conditions

Renal Failure Chronic Requiring Dialysis Diabetes Complications Diabetes Mellitus Diabetes Mellitus, With Complications Digestive System Diseases Endocrine System Diseases Exocrine Pancreatic Insufficiency Glomerulosclerosis Pancreas Transplantation Pancreatic Diseases Pancreatic Insufficiency (Exocrine and Endocrine) Transplantation, Kidney

Age range

20 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Central Manchester University Hospital

Manchester, M13 9WU, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Magnesium Sulfate high dose

Drug

Patients undergoing simultaneous pancreas-kidney (SPK) transplantation who gave their consent were given an intravenous magnesium supplement at a dose of 45-50 mg/kg over the course of an hour during the procedure.

Primary outcomes

  1. Serum magnesium levels.

    Time frame: 48 hours

    Serum magnesium levels after surgery at 12 and 48 hours.

  2. Perioperative cardiovascular incidents.

    Time frame: 48 hours

    Incidence rate of intraoperative and postoperative dysrhythmia events for each patient.

Secondary outcomes

  1. Postoperative neurological incidents.

    Time frame: 48 hours

    Incidence rate of postoperative confusion, muscle spasms, or weakness in each patient.

Sponsors and collaborators

Lead sponsor

Dr Olu Bamgbade, MD, FRCPC

Other

Collaborators

  • Manchester University NHS Foundation Trust

Registry information

Official study title

Perioperative Magnesium Supplementation in Simultaneous Pancreas-Kidney Transplantation Patients

Important dates

Study start
2008
Primary completion
2020
Study completion
2020
First posted
Jan 9, 2025
Registry last updated
Jan 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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