Study Stopped
organisational problems
Sponsor study identifier
interventional
0
1 country
1
Study Start
December 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2024
Actual (reported)Study Completion
April 2024
Actual (reported)The purpose of this study is to find out whether adding insulin after current colorectal cancer surgery promotes making and keeping proteins in the body, and to find out whether or not this effect can be further increased by increasing the amount of protein given.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2024
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2013
Date type not reportedThis date has not been verified as actual or estimated.
January 8, 2014
Actual (reported)January 10, 2014
Actual (reported)April 2024
Actual (reported)April 2024
Actual (reported)Net protein balance
The difference in total body protein after randomization to one of the three treatment arms.
6 hours after surgery
Insulin (hyperinsulinemic-normoglycemic clamp) with Travasol (amino acid supplementation) given from start of surgery to 6 hours after, at an amount of 35% of patient's energy expenditure as measured before surgery, .
Insulin (hyperinsulinemic-normoglycemic clamp) with Travasol (amino acid infusion), given from start of surgery to 6 hours after, at an amount of 20% of patient's energy expenditure as measured before surgery.
an amino acid supplementation infused intravenously containing essential and non-essential amino acids
McGill University Health Centre (MUHC) - Royal Victoria Hospital
Montreal, Quebec, H8A1A1, Canada
Schricker T, Meterissian S, Wykes L, Eberhart L, Lattermann R, Carli F. Postoperative protein sparing with epidural analgesia and hypocaloric dextrose. Ann Surg. 2004 Nov;240(5):916-21. doi: 10.1097/01.sla.0000143249.93856.66.
Schricker T, Wykes L, Carli F. Epidural blockade improves substrate utilization after surgery. Am J Physiol Endocrinol Metab. 2000 Sep;279(3):E646-53. doi: 10.1152/ajpendo.2000.279.3.E646.
Thomas Schricker, MD
McGill University Health Centre/Research Institute of the McGill University Health Centre
0 participants (actual enrollment reported by the registry).
First Submitted
January 8, 2014
First Posted
January 10, 2014
Study Start
December 2013
Date type not reportedThis date has not been verified as actual or estimated.
Insulin (hyperinsulinemic-normoglycemic clamp, an insulin infusion between 2 and 5 microunits/kg with glucose at a variable rated titrated to maintain normoglycemia, blood glucose 4-6 mmol/L) with no protein supplementation from start of surgery to 6 hours after.
After the insertion of an arterial catheter and obtaining a baseline arterial blood glucose value, 2 units of insluin will be administered iv followed by an infusion of 2 microunits/kg\*min. Ten minuts after starting the insulin, and when the the blood glucose is\<6 mmol/L, dextrose 20% supplemented with phosphate (30mmol/L) will be infused. Blood glucose levels measured every 15 minutes and the dextrose infusion rate adjusted to maintain arterial glycemia between 4 and 6 mmol/L until end of study.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Bellon F, Sola I, Gimenez-Perez G, Hernandez M, Metzendorf MI, Rubinat E, Mauricio D. Perioperative glycaemic control for people with diabetes undergoing surgery. Cochrane Database Syst Rev. 2023 Aug 1;8(8):CD007315. doi: 10.1002/14651858.CD007315.pub3.
Primary Completion
April 2024
Actual (reported)Study Completion
April 2024
Actual (reported)Last Updated
October 8, 2026
Record last verified: 2023-03
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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