Home » Trials » SLCTR/2014/005
A randomized placebo controlled trial on the effect of insulin in reducing skeletal muscle reperfusion injury.
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SLCTR Registration Number
SLCTR/2014/005
Date of Registration
The date of last modification
Mar 03, 2019
Scientific Title of Trial
A randomized placebo controlled trial on the effect of insulin in reducing skeletal muscle reperfusion injury.
Public Title of Trial
Study to assess the impact of insulin on reperfusion injury after skeletal muscle ischaemia
Disease or Health Condition(s) Studied
Reperfusion injury
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
EC-11-166 (Ethics Review Committee of the Faculty of Medicine, University of Colombo)
What is the research question being addressed?
What is the effect of insulin in reducing skeletal muscle reperfusion injury?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Single blinded
Control
Placebo
Assignment
Parallel
Purpose
Prevention
Study Phase
Phase 2
Intervention(s) planned
Consenting participants will be randomized into two arms.
The intervention arm will receive at the point of diagnosis a glucose-insulin-potassium (GIK) infusion (40 mmol KCl, in 1 liter of 10% dextrose at 60 ml/hr and human regular insulin [Novo Nordisk Pharmaceuticals] at 2.5 U/hr separately) until 12 hours post-reperfusion. GIK infusions will be titrated to maintain glucose between 80 and 180 mg/dl by hourly capillary blood sugar measurements via a standardized single glucometer. The potassium levels are to be maintained between 4 and 5 mmol/L. The range of glucose and potassium aforementioned are devised according to standard guidelines
Participants of the control arm will receive 1L normal saline at 60 ml/hr until 24 hours post-reperfusion.
Other supportive therapy will continue as indicated for both arms.
Inclusion criteria
Exclusion criteria
Primary outcome(s)
|
1.
Absolute difference from baseline (pre perfusion) concentration of
1. Tumour Necrosis Factor (TNF)-alpha |
[ Pre perfusion (baseline) and post-perfusion at 0, +2, +4, +6, +12 hours post-reperfusion ] |
Secondary outcome(s)
|
1.
|
[ at 48 hours post reperfusion ] |
Target number/sample size
24
Countries of recruitment
Sri Lanka
Anticipated start date
2014-04-01
Anticipated end date
2015-04-01
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
None
Regulatory approvals
Status
Approved
Date of Approval
2012-01-19
Approval number
EC-11-166
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Colombo |
| Institutional Address: | No. 25, Kynsey Road, Colombo 00800 Sri Lanka |
| Telephone: | +94-11-2695300 (Extension: 240) |
| Email: | ethicscommitteemfc@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr. Thushan Gooneratne
Registrar in Surgery
Postgraduate Institute of Medicine
No. 160, Norris Canal Road
Colombo 7
0094772004092
thushey@hotmail.com
Contact Person for Public Queries
Prof. Mandika Wijeyaratne
Professor in Surgery
Professorial Surgical Unit
National Hospital of Sri Lanka
009411-2691111
mandika59@hotmail.com
Primary study sponsor/organization
Professorial Surgical Unit
National Hospital of Sri Lanka
Colombo 10
+9411-2691111
http://www.nationalhospital.lk
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
