Renal Failure Chronic Requiring DialysisNCT06766786
Magnesium Supplementation in Simultaneous Pancreas-Kidney Transplantation
An observational study of Renal Failure Chronic Requiring Dialysis and Diabetes Mellitus, with Complications, run by Dr Olu Bamgbade, MD, FRCPC at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 99 years
- Conditions the study is for
- Renal Failure Chronic Requiring Dialysis, Diabetes Mellitus, with Complications, Glomerulosclerosis
- What is being tested?
- Magnesium Sulfate high dose
- Type of treatment
- Injection or infusion
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Jan 2008to 20 Feb 2020
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Adult diabetic patients who require insulin therapy and hemodialysis due to pancreatic-kidney failure.
Who cannot join
- Adult diabetic patients who do not require insulin therapy and hemodialysis.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Central Manchester University Hospital
Manchester, Manchester, M13 9WU
About this study
Official title: 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.
Read the 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.
- Conditions
- Renal Failure Chronic Requiring Dialysis, Diabetes Mellitus, with Complications, Glomerulosclerosis, Pancreatic Insufficiency (Exocrine and Endocrine), Transplantation, Kidney, Pancreas Transplantation
- Being tested
- Magnesium Sulfate high dose
- Keywords
- SPK transplant, Simultaneous pancreas-kidney (SPK) transplant, Hypomagnesemia transplantation, Hypomagnesemia kidney transplant, Hypomagnesemia pancreas-kidney transplant, Hypomagnesemia simultaneous pancreas-kidney transplant
- Medical subject headings
- Diabetes Complications, Exocrine Pancreatic Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Magnesium Sulfate high dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum magnesium levels.
Serum magnesium levels after surgery at 12 and 48 hours.
Measured: 48 hours
Perioperative cardiovascular incidents.
Incidence rate of intraoperative and postoperative dysrhythmia events for each patient.
Measured: 48 hours
Secondary outcomes (1)
Postoperative neurological incidents.
Incidence rate of postoperative confusion, muscle spasms, or weakness in each patient.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start2 Jan 2008
- Primary completion20 Feb 2020
- Study completion20 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal Failure Chronic Requiring DialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Dr Olu Bamgbade, MD, FRCPC
- Sponsor type
- University, hospital or other
- Collaborators
- Manchester University NHS Foundation Trust
- Responsible party
- Sponsor-investigator, Dr Olu Bamgbade, MD, FRCPC, Salem Anaesthesia Pain Clinic
- Investigators
- Olumuyiwa Bamgbade, MD, FRCPC, Study director, Salem Anaesthesia Pain Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06766786
- Sponsor's protocol ID
- SalemAne Magnesia SPK Transpl
- Status last verified
- Jan 2025
- First submitted
- 5 Jan 2025
- Last updated
- 9 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data may be shared after the research has been analyzed and published.
Publications
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.
PubMed 29100019
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Magnesium Supplementation in Simultaneous Pancreas-Kidney Transplantation Patients
- ClinicalTrials.gov ID
- NCT06766786
- Acronym / sponsor ID
- SalemAne Magnesia SPK Transpl
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Dr Olu Bamgbade, MD, FRCPCUniversity, hospital or other
- Collaborators
- Manchester University NHS Foundation Trust
- Study start
- 2 Jan 2008 (actual)
- Primary completion
- 20 Feb 2020 (actual)
- Study completion
- 20 Feb 2020 (actual)
- First posted
- 9 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic pancreas-kidney failure. | – | Drug: Magnesium Sulfate high doseAdult 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. |
Who may qualify
- Ages
- 20 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Adult diabetic patients who require insulin therapy and hemodialysis due to pancreatic-kidney failure.
Key exclusion criteria (1 listed)
- Adult diabetic patients who do not require insulin therapy and hemodialysis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnesium Sulfate high dosePatients 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. | Drug | Chronic pancreas-kidney failure. |
Primary outcome
Serum magnesium levels.
Time frame: 48 hours
Serum magnesium levels after surgery at 12 and 48 hours.
Perioperative cardiovascular incidents.
Time frame: 48 hours
Incidence rate of intraoperative and postoperative dysrhythmia events for each patient.
1 secondary outcome
Postoperative neurological incidents.
Time frame: 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2025.
- Background: PubMed 29100019Bamgbade 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.
- Individual participant dataSharing planned: Undecided. Data may be shared after the research has been analyzed and published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olumuyiwa Bamgbade, MD, FRCPC study director
Salem Anaesthesia Pain Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Failure Chronic Requiring Dialysis and Diabetes Mellitus, with Complications, run by Dr Olu Bamgbade, MD, FRCPC at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum magnesium levels. (time frame: 48 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06766786, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2025; AzTrials last refreshed its copy on 26 Oct 2026.