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.: PACTR201710000932829 Date of Approval: 07/11/2014
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title A RCT comparing eMPC to paper-based model with regards to glucose control in trauma ICU patients
Official scientific title Insulin therapy and glucose control in ICU: a prospective, randomised, controlled trial comparing enhanced model predictive control to paper-based method in critically ill trauma patients
Brief summary describing the background and objectives of the trial Glucose control (GC) has been shown to improve outcomes in critically ill patients by reducing the incidence of critical-ilness induced dysglycaemia. There is a shortage of trials in a sub-group of trauma patients within this population. GC by means of paper-based insulin infusion protocols is difficult to achieve - they are often complicated, are prone to human error, not well adhered to, and increase nursing workload. Computer decision support systems (of which enhanced model predictive control is one type) have been developed with the goal of improving the efficiency and safety of GC whilst reducing the nursing workload and increasing compliance. This trial aims to compare our current paper-based standard of care for GC in critically ill trauma patients to an eMPC algorithm. Primary end point will be 1)SG variability. Secondary end points will be 1)average time spent within target range 2)overall mean SG levels 3)time spent above target range 4)SG sampling interval. The trial will be underpowered to use hypoglycaemia as a primary end-point, but the incidence thereof will still be commented on. We hypothesise that the eMPC will out-perform our current paper-based standard of care with regards to efficacy and reduction of nursing workload.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Glucose control in critically ill trauma patients,Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 05/01/2015
Actual trial start date 01/07/2016
Anticipated date of last follow up 31/12/2017
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
3919 (DOH number pending) NHREC
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
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomisation; 10 blocks of 6 Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group enhanced model predictive control insulin infusion as per computerised protocol 72 hours maximum insulin infusion as per computerised algorithm 30
Control Group paper-based insulin infusion protocol insulin infusion as per paper-based protocol 72 hours maximum insulin infusion as per paper-based protocol 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1)critically ill trauma patients requiring ICU admission 2) no threshold serum glucose necessary for inclusion; insulin infusion to be commenced on admission 3) non-diabetics only 4) anticipated length of stay of at least 24 hours 5) intravenous insulin administration via peripheral or central line 6) arterial line for blood sampling 1) patient or family refusal 2) pregnancy 3) burns 4) traumatic brain injury with GCS <8 5) moribund with likely demise within 24 hours 6) Diabetics, DKA or hyperosmolar state 7) renal dysfunction 18 Year(s) 60 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 12/11/2014 UCT FHS ethics committe
Ethics Committee Address
Street address City Postal code Country
E52, Room 24, Old Main Building, Groote Schuur Hospitla, Observatory Cape Town 7925 South Africa
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 12/04/2016 UCT FHS ethics committe
Ethics Committee Address
Street address City Postal code Country
E52, Room 24, Old Main Building, Groote Schuur Hospitla, Observatory Cape Town 7925 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Secondary Outcome average time spent within target serum glucose range 72hrs
Secondary Outcome overall mean serum glucose levels 72 hrs
Primary Outcome average serum glucose variability 72 hrs
Secondary Outcome time spent above target range 72 hrs
Secondary Outcome serum glucose sampling interval 72 hrs
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ward D12 ICU, New Groote Schuur Hospital Main Rd, Observatory Cape Town 7925 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
UCT Dept Anaesthesia D23 New Groote Schuur Hospital, Main Rd, Observatory Cape Town 7925 South Africa
Lowellen Clarke (MMed student) PO Box 15600, Vlaeberg Cape Town 8018 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor UCT Dept Anaesthesia D23 New Groote Schuur Hospital, Main Rd, Observatory Cape Town 7925 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Dr Ivan Joubert D23 New Groote Schuur Hospital, Main Rd, Observatory Cape Town 7925 South Africa
Dr Jenna Piercy D23, New Groote Schuur Hospital, Main Rd, Observatory Cape Town 7925 South Africa
Dr Lowellen Clarke D23, New Groote Schuur Hospital, Main Rd, Observatory Cape Town 7925 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ivan Joubert ivan.joubert@uct.ac.za 021 404 3279 D23, New Groote Schuur Hospital, Main Rd, Observatory
City Postal code Country Position/Affiliation
Cape Town 7925 South Africa Clinical Lead ICU
Role Name Email Phone Street address
Public Enquiries Lowellen Clarke lowellenclarke@gmail.com 021 404 5000 D23, New Groote Schuur Hospital, Main Rd, Observatory
City Postal code Country Position/Affiliation
Cape Town 7925 South Africa Registrar, Anaesthesia
Role Name Email Phone Street address
Scientific Enquiries Lowellen Clarke lowellenclarke@gmail.com 021 404 5000 D23 New Groote Schuur Hospital, Main Rd, Observatory
City Postal code Country Position/Affiliation
Cape Town 7925 South Africa Registrar, Anaesthesia
REPORTING
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