Preoperative Glucose Infusion: a Novel Strategy to Improve Liver Function After Liver Resection
Metabolic Preconditioning Using Intravenous Dextrose: a Novel Strategy to Improve Hepatic Function After Liver Resection
2 other identifiers
interventional
50
1 country
1
Brief Summary
The goal of the study is to determine whether intravenous glucose administration before liver resection preserves hepatic glycogen resulting in improved hepatic metabolic function after the operation. We further investigate whether the benefit of avoiding preoperative fasting is more pronounced in patients undergoing more extensive liver resection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2008
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 15, 2008
CompletedFirst Posted
Study publicly available on registry
February 26, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2019
CompletedApril 3, 2018
April 1, 2018
11.1 years
February 15, 2008
April 2, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of albumin synthesis
One day before and one day after surgery
Secondary Outcomes (1)
Transthyretin synthesis, fibrinogen synthesis, whole body glucose and protein kinetics
One day before and one day after surgery
Study Arms (2)
1
ACTIVE COMPARATORGlucose infusion.
2
PLACEBO COMPARATORNormal saline infusion.
Interventions
Glucose infusion from 15:00 on the day before the operation until beginning of surgery.
Normal saline infusion from 15:00 on the day before surgery until beginning of the operation.
Eligibility Criteria
You may qualify if:
- American Society of Anesthesiologists class ≤3
- liver resection (one or more liver segments) for primary or secondary malignancy
- ability to give informed consent
You may not qualify if:
- signs of severe malnutrition or obesity: body mass index (BMI) \<20 or \>30 kg.m-2, more than 10% involuntary body weight loss over the preceding six months, serum albumin \<35 g.L-1
- chronic viral liver disease
- diabetes mellitus
- significant cardiorespiratory, renal and neurological disease
- musculoskeletal or neuromuscular disease
- severe anemia (hemoglobin \<10 g.dL-1)
- history of severe sciatica or back surgery or other conditions which contraindicate the use of an epidural catheter
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Royal Victoria Hospital, McGill University Health Centre
Montreal, Quebec, H3A 1A1, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ralph Lattermann, MD PhD
Department of Anaesthesia, McGill University Health Centre
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
February 15, 2008
First Posted
February 26, 2008
Study Start
February 1, 2008
Primary Completion
March 1, 2019
Study Completion
March 1, 2019
Last Updated
April 3, 2018
Record last verified: 2018-04