Liver FunctionNCT00774098
Improving Glycogen Liver Content Will Improve Post-operative Liver Function in Patients Undergoing Major Liver Resections
A study testing dextrose 10% (D10W ®) infusion, hyperinsulinemic normoglycemic clamp and high calorie diet 35 kcal/kg in people with Liver Function, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial summary
We would like to study the effect of preserving liver glycogen storage by using intravenous dextrose infusion on postoperative liver function and complications after major liver resections. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Function
- What is being tested?
- dextrose 10% (D10W ®) infusion, hyperinsulinemic normoglycemic clamp and high calorie diet 35 kcal/kg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2007to Sep 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- planned to undergo a major liver resection at McGill University Health Center (MUHC)
Who cannot join
- patients known with chronic viral liver disease
- uncontrolled or type one diabetes mellitus (DM)
- patients on oral beta-blocker agents
- patients with unresectable disease determined intra-operatively
- patients unable to give consent for the study.
Trial locations and contacts
1 site in 1 country.
About this study
We would like to study the effect of preserving liver glycogen storage by using intravenous dextrose infusion on postoperative liver function and complications after major liver resections.
- Conditions
- Liver Function
- Being tested
- dextrose 10% (D10W ®) infusion, hyperinsulinemic normoglycemic clamp, high calorie diet 35 kcal/kg, Intravenous normal saline (NS 0.9)
- Keywords
- all adult patients (>18 years) planned to undergo a major liver resection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dextrose 10% (D10W ®) infusionDrug
Started at 8pm the day before surgery until the procedure begins
hyperinsulinemic normoglycemic clampDrug
Started as the procedure begins, decreased at the end of the procedure and continued until 16 hours postoperatively
high calorie diet 35 kcal/kgDietary supplement
High Calorie meals start the day before the surgery and are given 5 hours apart. The last meal is given at 7 pm the day before surgery
Intravenous normal saline (NS 0.9)Drug
Intravenous normal saline (NS 0.9) started just before induction, and titrated to hemodynamic parameters and urine output
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Placebo comparator | Intravenous normal saline (NS 0.9) started just before induction, and titrated to hemodynamic parameters and urine output Receives: Drug: Intravenous normal saline (NS 0.9) |
| GICP | Experimental | Not described Receives: Drug: dextrose 10% (D10W ®) infusion; Drug: hyperinsulinemic normoglycemic clamp; Dietary Supplement: high calorie diet 35 kcal/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative liver function test
Measured: Postoperative
Secondary outcomes (2)
Liver and muscle glycogen, TG, and protein content at beginning and end of the procedure.
Measured: Begining + end of the procedure
Incidence of complications
Measured: Postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2008 (estimated)
- Study startJan 2007
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Liver FunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00774098
- Sponsor's protocol ID
- SDR-06-012
- Status last verified
- Mar 2010
- First submitted
- 15 Oct 2008
- Last updated
- 1 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Hassanain M, Metrakos P, Fisette A, Doi SA, Schricker T, Lattermann R, Carvalho G, Wykes L, Molla H, Cianflone K. Randomized clinical trial of the impact of insulin therapy on liver function in patients undergoing major liver resection. Br J Surg. 2013 Apr;100(5):610-8. doi: 10.1002/bjs.9034. Epub 2013 Jan 21.
PubMed 23339047Fisette A, Hassanain M, Metrakos P, Doi SA, Salman A, Schricker T, Lattermann R, Wykes L, Nitschmann E, Smith J, Cianflone K. High-dose insulin therapy reduces postoperative liver dysfunction and complications in liver resection patients through reduced apoptosis and altered inflammation. J Clin Endocrinol Metab. 2012 Jan;97(1):217-26. doi: 10.1210/jc.2011-1598. Epub 2011 Oct 26.
PubMed 22031518Sato H, Lattermann R, Carvalho G, Sato T, Metrakos P, Hassanain M, Matsukawa T, Schricker T. Perioperative glucose and insulin administration while maintaining normoglycemia (GIN therapy) in patients undergoing major liver resection. Anesth Analg. 2010 Jun 1;110(6):1711-8. doi: 10.1213/ANE.0b013e3181d90087. Epub 2010 Apr 7.
PubMed 20375299
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Glycogen Liver Content Will Improve Post-operative Liver Function in Patients Undergoing Major Liver Resections
- ClinicalTrials.gov ID
- NCT00774098
- Acronym / sponsor ID
- SDR-06-012
- Conditions
- Liver Function
- Keywords
- all adult patients (>18 years) planned to undergo a major liver resection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 17 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We would like to study the effect of preserving liver glycogen storage by using intravenous dextrose infusion on postoperative liver function and complications after major liver resections.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Placebo comparator | Drug: Intravenous normal saline (NS 0.9)Intravenous normal saline (NS 0.9) started just before induction, and titrated to hemodynamic parameters and urine output |
| GICP | Experimental | Drug: dextrose 10% (D10W ®) infusion, Drug: hyperinsulinemic normoglycemic clamp, Dietary Supplement: high calorie diet 35 kcal/kg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years or older
- planned to undergo a major liver resection at McGill University Health Center (MUHC)
Key exclusion criteria (5 listed)
- patients known with chronic viral liver disease
- uncontrolled or type one diabetes mellitus (DM)
- patients on oral beta-blocker agents
- patients with unresectable disease determined intra-operatively
- patients unable to give consent for the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dextrose 10% (D10W ®) infusionStarted at 8pm the day before surgery until the procedure begins | Drug | GICP |
| hyperinsulinemic normoglycemic clampStarted as the procedure begins, decreased at the end of the procedure and continued until 16 hours postoperatively | Drug | GICP |
| high calorie diet 35 kcal/kgHigh Calorie meals start the day before the surgery and are given 5 hours apart. The last meal is given at 7 pm the day before surgery | Dietary supplement | GICP |
| Intravenous normal saline (NS 0.9)Intravenous normal saline (NS 0.9) started just before induction, and titrated to hemodynamic parameters and urine output | Drug | Control Group |
Primary outcome
Postoperative liver function test
Time frame: Postoperative
2 secondary outcomes
Liver and muscle glycogen, TG, and protein content at beginning and end of the procedure.
Time frame: Begining + end of the procedure
Incidence of complications
Time frame: Postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2010.
- Derived from this study: PubMed 23339047Hassanain M, Metrakos P, Fisette A, Doi SA, Schricker T, Lattermann R, Carvalho G, Wykes L, Molla H, Cianflone K. Randomized clinical trial of the impact of insulin therapy on liver function in patients undergoing major liver resection. Br J Surg. 2013 Apr;100(5):610-8. doi: 10.1002/bjs.9034. Epub 2013 Jan 21.
- Derived from this study: PubMed 22031518Fisette A, Hassanain M, Metrakos P, Doi SA, Salman A, Schricker T, Lattermann R, Wykes L, Nitschmann E, Smith J, Cianflone K. High-dose insulin therapy reduces postoperative liver dysfunction and complications in liver resection patients through reduced apoptosis and altered inflammation. J Clin Endocrinol Metab. 2012 Jan;97(1):217-26. doi: 10.1210/jc.2011-1598. Epub 2011 Oct 26.
- Derived from this study: PubMed 20375299Sato H, Lattermann R, Carvalho G, Sato T, Metrakos P, Hassanain M, Matsukawa T, Schricker T. Perioperative glucose and insulin administration while maintaining normoglycemia (GIN therapy) in patients undergoing major liver resection. Anesth Analg. 2010 Jun 1;110(6):1711-8. doi: 10.1213/ANE.0b013e3181d90087. Epub 2010 Apr 7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dextrose 10% (D10W ®) infusion, hyperinsulinemic normoglycemic clamp and high calorie diet 35 kcal/kg in people with Liver Function, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative liver function test (time frame: Postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00774098, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2010.