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: pactr.samrc.ac.za
Trial no.: PACTR2009100001631792 Date of Approval: 12/10/2009
Trial Status: Registered in accordance with WHO and ICMJE standards
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 Hyperkalaemia,Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 09/10/2009
Actual trial start date
Anticipated date of last follow up 18/10/2010
Actual Last follow-up date 18/10/2010
Anticipated target sample size (number of participants) 0
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL http://www.karger.com/Article/Abstract/358836
Secondary Ids Issuing authority/Trial register
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
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 Care giver/Provider,Outcome Assessors,Participants
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-Treatment of Control Group
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 Age Category Minimum age Maximum 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 Year(s) 70 Year(s) 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 30/09/2009 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 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
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
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
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 Street address
Principal Investigator Mogamat Razeen Davids mrd@sun.ac.za +27-21-9389246 Stellenbosch University Division of Nephrology, Francie van Zijl Avenue
City Postal code Country Position/Affiliation
Cape Town 7505 South Africa Head: Division of Nephrology
Role Name Email Phone Street address
Public Enquiries Jennifer Stopford jennifer@sun.ac.za +27-21-9389074 Stellenbosch University Department of Medicine, Francie van Zijl Avenue
City Postal code Country Position/Affiliation
Cape Town 7505 South Africa Personal assistant
Role Name Email Phone Street address
Scientific Enquiries Mogamat Razeen Davids mrd@sun.ac.za +27-21-9389246 Stellenbosch University Division of Nephrology, Francie van Zijl Avenue
City Postal code Country Position/Affiliation
Cape Town 7505 South Africa Head: Division of Nephrology
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information