Magnesium Supplementation in Simultaneous Pancreas-Kidney Transplantation

January 5, 2025 updated by: Dr Olu Bamgbade, MD, FRCPC

Perioperative Magnesium Supplementation in Simultaneous Pancreas-Kidney Transplantation Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Manchester, United Kingdom, M13 9WU
        • Central Manchester University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Chronic pancreas-kidney failure.
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.
Drug: Magnesium Sulfate high dose
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum magnesium levels.
Time Frame: 48 hours
Serum magnesium levels after surgery at 12 and 48 hours.
48 hours
Perioperative cardiovascular incidents.
Time Frame: 48 hours
Incidence rate of intraoperative and postoperative dysrhythmia events for each patient.
48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative neurological incidents.
Time Frame: 48 hours
Incidence rate of postoperative confusion, muscle spasms, or weakness in each patient.
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr Olu Bamgbade, MD, FRCPC

Collaborators

Central Manchester University Hospitals NHS Foundation Trust (co-sponsor, UK)

Investigators

  • Study Director: Olumuyiwa Bamgbade, MD, FRCPC, Salem Anaesthesia Pain Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2008

Primary Completion (Actual)

February 20, 2020

Study Completion (Actual)

February 20, 2020

Study Registration Dates

First Submitted

January 5, 2025

First Submitted That Met QC Criteria

January 5, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 5, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SalemAne Magnesia SPK Transpl

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Data may be shared after the research has been analyzed and published.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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