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.: PACTR201710002591405 Date of Approval: 07/09/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of Hydroxyethyl Starch (Voluven 130/0.4) on Bloof Glucose Levels during Othtopaedic Lower Limb Surgery Under Spinal Anaesthesia
Official scientific title Effect of Hydroxyethyl Starch (Voluven 130/0.4) on Bloof Glucose Levels during Othtopaedic Lower Limb Surgery Under Spinal Anaesthesia
Brief summary describing the background and objectives of the trial Multiple studies have been performed evaluating the effect of Hydroxyethyl Starch (HES) on blood glucose levels. However, none of these studies have examined the effect of a 3rd generation HES in saline on blood glucose levels. Voluven® (6% 130/0.4) has a lower molecular weight and a lower degree of molar substitution compared to 1st and 2nd generation HES products. Due to its physicochemical characteristics, Voluven® has a faster rate of hydrolysis by ¿-amylase and the ability to release glucose residues more rapidly, having the potential to induce or potentiate hyperglycaemia. This research will therefore assess the impact of a particular HES, Voluven®, on perioperative glucose homeostasis in non-diabetic patients. This study will therefore fill the gap in current literature. Objectives: 1. To determine the effect of HES (Voluven® 130/0.4) on blood glucose levels. 2. To compare the basal to serial blood glucose levels between patients receiving Voluven® to those receiving Normal saline. 3. To make a future recommendation to perform a similar study on the effect of HES (Voluven® 130/0.4) on blood glucose levels in diabetic patients (This will be my own follow-up study to complete my PhD).
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Hyperglycaemia,Nutritional, Metabolic, Endocrine,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 25/09/2017
Actual trial start date
Anticipated date of last follow up 03/11/2017
Actual Last follow-up date
Anticipated target sample size (number of participants) 140
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
Protocol number: 027/2017 Walter Sisulu University Human Research Ethics Committee
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 Simple Randomisation using computer-generated sequence in Excel Not concealed from investigator Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Normal Saline 0.9% 7.5ml/kg 30min before induction of Spinal Anaesthesia A calculated dose (7.5ml.kg-1) of Normal saline will be administered over a period of 30 minutes prior to the induction of spinal anaesthesia. Following the initial infusion, all patients will receive Normal saline as subsequent maintenance fluids until the end of the study. Throughout the study, a total of five blood glucose measurements will be made at set intervals 70 Placebo
Experimental Group Voluven 7.5ml/kg 30min before induction of Spinal Anaesthesia A calculated dose (7.5ml.kg-1) of Voluven will be administered over a period of 30 minutes prior to the induction of spinal anaesthesia. Following the initial infusion, all patients will receive Normal saline as subsequent maintenance fluids until the end of the study. Throughout the study, a total of five blood glucose measurements will be made at set intervals 70
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Age: 18-65 years Weight: 40-90 kg ASA: 1 and 2 Scheduled lower limb surgery under spinal anaesthesia Diabetes mellitus or any other condition with abnormal glucose metabolism Drugs: Ascorbic acid, Steroids, Adrenergic drugs Low Haemoglobin < 8mg/dl (equivalent to a low haematocrit of 24%) Known allergy to HES products Patients with a history of Renal or Cardiac (NYHA class 3 and 4) dysfunction Coagulation disorders Patients with significant blood loss requiring a blood transfusion 18 Year(s) 65 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 30/08/2017 Walter Sisulu University Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Ian Woods Drive Mthatha 5117 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Blood Glucose Level Basal (immediately prior to initial infusion) 15 minutes 30 minutes 60 minutes 120 minutes after the start of the infusion
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Frere Hospital Amalinda Main Road, Braelyn East London 5201 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Frere Hospital Amalinda Main Road, Braelyn East London 5201 South Africa
Personal Capacity Amalinda Main Road, Braelyn East London 5201 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Walter Sisulu University Ian Woods Drive Mthatha 5117 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Frere Hospital Amalinda Main Road, Braelyn East London 5201 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Karmelle van Rensburg karmelle.vrensburg@gmail.com 082 0456527 Frere Hospital, Amalinda Main Road, Braelyn
City Postal code Country Position/Affiliation
East London 5201 South Africa Anaesthetic Registrar
Role Name Email Phone Street address
Public Enquiries Karmelle van Rensburg karmelle.vrensburg@gmail.com 082 0456527 Frere Hospital, Amalinda Main Road, Braelyn
City Postal code Country Position/Affiliation
East London 5201 South Africa Anaesthetic Registrar
Role Name Email Phone Street address
Scientific Enquiries David Morrell david.francis.morrell@gmail.com 043 709 2529 Frere Hospital, Amalinda Main Road, Braelyn
City Postal code Country Position/Affiliation
East London 5201 South Africa Head of Department of Anaesthesiolgy
REPORTING
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Result URL Hyperlinks
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