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Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834     Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za     Website: www.pactr.org

Trial no.: PACTR2009100001631792 Date registered: 2009/10/06
TRIAL DESCRIPTION
Public title Efficacy of a glucose bolus versus glucose plus insulin in the treatment of hyperkalaemia
Official scientific title Efficacy of a glucose bolus versus glucose plus insulin in the treatment of hyperkalaemia
Brief summary describing the background
and objectives of the trial
Hyperkalaemia is a medical emergency which can lead to life-threatening cardiac arrhythmias. The principles of treatment include shifting potassium into cells using insulin plus glucose, ß2-agonists or sodium bicarbonate. Hypoglycaemia is a common side effect of insulin therapy for hyperkalaemia and this study investigates whether an intravenous glucose bolus alone will cause sufficient endogenous insulin secretion to shift potassium into cells to a clinically useful degree.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied
Purpose of the trial Treatment
Anticipated trial start date
Actual trial start date
Anticipated date of last follow up
Actual date of last follow up 2010-10-18
Anticipated target sample size (number of participants)   
Actual target sample size (number of participants) 10   
Recruitment status Open to recruitment: actively recruiting participants
Secondary Ids Issuing authority/Trial register Links to Secondary ID
Ethics reference no. M07/10/060 Committee for Clinical Trials - Stellenbosch University Faculty of Health Sciences
Ethics reference no. M07/10/060 Committee for Clinical Trials - Stellenbosch University Faculty of Health Sciences

STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person
allocating the participants to the intervention arms
Masking If masking / blinding was used
Crossover: all participants receive all interventions in different sequence during study Randomised Simple randomisation using a random number table Sequentially numbered sealed opaque envelopes Masking/blinding used

INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control group Insulin + glucose 10 units short acting insulin + 100 ml 50% dextrose water Rapid infusion over 5-7 minutes Standard therapy with insulin + glucose 10 Active
Experimental group Glucose bolus 100 ml 50% dextrose water Rapid infusion over 5-7 minutes Glucose bolus only 10

ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Min age Max age Gender
Stable chronic haemodialysis patients Adults aged 18 and over Willing to provide informed consent Diabetes mellitus Unstable cardiovascular disease Use of beta-blockers 18 Years 70 Years Both

ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval
Name of the ethics committee
Yes 2009/09/30 Committee for Clinical Trials, Stellenbosch University Faculty of Health Sciences
Ethics Committee Address
Street address City Postal code Country
Francie van Zijl Avenue, Tygerberg Cape Town 7505 South Africa

OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Plasma potassium concentrations Baseline 10 min 20 min 40 min 60 min
Secondary Outcome Blood glucose concentrations Baseline 10 min 20 min 40 min 60 min
Secondary Outcome Plasma insulin concentrations Baseline 10 min 20 min 40 min 60 min
Secondary Outcome Hypoglycaemic episodes Baseline 10 min 20 min 40 min 60 min

RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tygerberg Hospital Francie van Zijl Avenue Cape Town 7505 South Africa

FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty of Health and Wellness Sciences, Cape Peninsula University of Technology Symphony Way, Bellville Cape Town 7535 South Africa
Faculty of Health and Wellness Sciences, Cape Peninsula University of Technology Symphony Way, Bellville Cape Town 7535 South Africa

SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Prof MR Davids Department of Medicine, Stellenbosch University, Francie van Zijl Avenue Cape Town 7505 South Africa University
Primary Sponsor Prof MR Davids Department of Medicine, Stellenbosch University, Francie van Zijl Avenue Cape Town 7505 South Africa University

COLLABORATORS
Name Street address City Postal code Country
Dr M Rensburg Stellenbosch University & NHLS Division of Chemical Pathology, Francie van Zijl Avenue Cape Town 7505 South Africa
Dr MY Chothia Stellenbosch University Division of Nephrology, Francie van Zijl Avenue Cape Town 7505 South Africa
Prof Mitchell Halperin St Michaels Hospital, Shuter Street Toronto M5B 1A6 Canada
Mr MS Hassan Faculty of Health and Wellness Sciences; Cape Peninsula University of Technology, Symphony Way Cape Town 7535 South Africa
Dr M Rensburg Stellenbosch University & NHLS Division of Chemical Pathology, Francie van Zijl Avenue Cape Town 7505 South Africa
Dr MY Chothia Stellenbosch University Division of Nephrology, Francie van Zijl Avenue Cape Town 7505 South Africa
Prof Mitchell Halperin St Michaels Hospital, Shuter Street Toronto M5B 1A6 Canada
Mr MS Hassan Faculty of Health and Wellness Sciences; Cape Peninsula University of Technology, Symphony Way Cape Town 7535 South Africa

CONTACT PEOPLE
Role Name Email Phone Fax
Public Enquiries Mrs Jennifer Stopford jennifer@sun.ac.za +27-21-9389074 +27-21-9337442
Street address City Postal code Country Position / Affiliation
Stellenbosch University Department of Medicine, Francie van Zijl Avenue Cape Town 7505 South Africa Personal assistant
Role Name Email Phone Fax
Scientific Enquiries Prof Mogamat Razeen Davids mrd@sun.ac.za +27-21-9389246 +27-21-9337442
Street address City Postal code Country Position / Affiliation
Stellenbosch University Division of Nephrology, Francie van Zijl Avenue Cape Town 7505 South Africa Head: Division of Nephrology
Role Name Email Phone Fax
Principal Investigator Prof Mogamat Razeen Davids mrd@sun.ac.za +27-21-9389246 +27-21-9337442
Street address City Postal code Country Position / Affiliation
Stellenbosch University Division of Nephrology, Francie van Zijl Avenue Cape Town 7505 South Africa Head: Division of Nephrology