NCT06766786

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2008

Completed
12.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2020

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

January 5, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 9, 2025

Completed
Last Updated

January 9, 2025

Status Verified

January 1, 2025

Enrollment Period

12.1 years

First QC Date

January 5, 2025

Last Update Submit

January 5, 2025

Conditions

Renal Failure Chronic Requiring DialysisDiabetes Mellitus, with ComplicationsGlomerulosclerosisPancreatic Insufficiency (Exocrine and Endocrine)Transplantation, KidneyPancreas Transplantation

Keywords

SPK transplantSimultaneous pancreas-kidney (SPK) transplantHypomagnesemia transplantationHypomagnesemia kidney transplantHypomagnesemia pancreas-kidney transplantHypomagnesemia simultaneous pancreas-kidney transplant

Outcome Measures

Primary Outcomes (2)

  • Serum magnesium levels.

    Serum magnesium levels after surgery at 12 and 48 hours.

    48 hours

  • Perioperative cardiovascular incidents.

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

    48 hours

Secondary Outcomes (1)

  • Postoperative neurological incidents.

    48 hours

Study Arms (1)

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

Interventions

Magnesium Sulfate high doseDRUG

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.

Chronic pancreas-kidney failure.

Eligibility Criteria

Age20 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Central Manchester University Hospital

Manchester, Manchester, M13 9WU, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 29100019BACKGROUND

MeSH Terms

Conditions

Diabetes ComplicationsExocrine Pancreatic Insufficiency

Interventions

Magnesium Sulfate

Condition Hierarchy (Ancestors)

Diabetes MellitusEndocrine System DiseasesPancreatic DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Magnesium CompoundsInorganic ChemicalsSulfatesSulfuric AcidsSulfur AcidsSulfur Compounds

Study Officials

  • Olumuyiwa Bamgbade, MD, FRCPC

    Salem Anaesthesia Pain Clinic

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 5, 2025

First Posted

January 9, 2025

Study Start

January 2, 2008

Primary Completion

February 20, 2020

Study Completion

February 20, 2020

Last Updated

January 9, 2025

Record last verified: 2025-01

Locations

GB(1)