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Hepatic InsufficiencyNCT00623662

Preoperative Glucose Infusion: a Novel Strategy to Improve Liver Function After Liver Resection

A study testing Preoperative glucose infusion and Preoperative normal saline infusion in people with Hepatic Insufficiency and Liver Failure, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatic Insufficiency, Liver Failure
What is being tested?
Preoperative glucose infusion and Preoperative normal saline infusion
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
50 participants
Where
1 siteCanada
Study dates
Feb 2008to Mar 2019
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

  • American Society of Anesthesiologists class ≤3
  • liver resection (one or more liver segments) for primary or secondary malignancy
  • ability to give informed consent

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site, 1 recruiting
  • Royal Victoria Hospital, McGill University Health Centre

    Montreal, Quebec, H3A 1A1

    Ralph Lattermann, MD PhD, 514-934-1934 ext. 35802, ralph.lattermann@muhc.mcgill.ca

    Thomas Schricker, MD PhD, 514-934-1934 ext. 36057, thomas.schricker@mcgill.ca

    Recruiting

Other trials in Canada

About this study

Official title: Metabolic Preconditioning Using Intravenous Dextrose: a Novel Strategy to Improve Hepatic Function After Liver Resection

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.

Read the detailed description

Background. With a reported incidence of up to 70%, liver failure is the most frequent complication necessitating intensive care and prolonging hospital stay. Animal studies suggest that the glycogen content of the liver is a key regulator of liver function and that glycogen depletion, a mandatory consequence of preoperative fasting, is associated with poor clinical outcome.

The results of a pilot study demonstrate that metabolic preconditioning, i.e. the avoidance of preoperative fasting by intravenous administration of dextrose preserves hepatic glycogen and prevents hepatic dysfunction after liver resection. Liver function in this protocol was assessed by a score originally proposed by Schindl including serum concentrations of total bilirubin and lactate, prothrombin time and degree of encephalopathy. Due to alterations induced by anesthesia and surgery, e.g. blood loss necessitating transfusion, hypothermia, inflammatory responses and use of drugs with impact on hepatobiliary metabolism, liver function scores do not necessarily reflect functional integrity and metabolic capacity of the liver. In contrast, measuring the production of proteins that are exclusively synthetized by hepatocytes such as albumin allows a more specific and quantitative assessment of hepatic performance under perioperative conditions.

Hypothesis. We propose a randomized double-blinded study to test the hypothesis that, in patients scheduled for resection of liver cancer, metabolic preconditioning with intravenous dextrose preserves hepatic glycogen resulting in improved hepatic metabolic function postoperatively. We further hypothesize that the benefit of avoiding preoperative fasting is more pronounced in patients undergoing more extensive liver resection. Hepatic synthetic capacity will be assessed by measuring albumin synthesis using a stable isotope tracer technique.

Research plan. In order to test the validity of our assumptions, we will perform studies in patients scheduled for minor (study I; one or two liver segments, n=30) or major (study II; three or more liver segments, n=20) liver resection. In a double blinded fashion patients will be randomly assigned to receive either intravenous dextrose at 2 mg/kg/min or saline from 15:00 on the day before the operation until surgical skin incision. Metabolic processes at the organ level (liver, muscle), i.e. fractional synthesis rates of albumin, hepatic acute phase proteins (transthyretin (=prealbumin), fibrinogen, total plasma proteins) and muscle protein will be determined one day before and one day after the operation using primed-continuous infusions of L-[2H5]phenylalanine. Stable isotopes (L-[1-13C]leucine, [6,6-2H2]glucose) will be applied to assess dynamic changes in whole body protein and glucose metabolism before and after surgery, i.e. protein breakdown, amino acid oxidation, protein synthesis, glucose production and glucose uptake.

Significance. The demonstration that the preconditioning with dextrose preserves metabolic performance of the liver would have important implications for the clinical management of surgical patients with liver cancer. If preoperative dextrose administration attenuates hepatic dysfunction after liver resection, it will provide these patients with a readily available, safe and inexpensive therapy.

Being tested
Preoperative glucose infusion, Preoperative normal saline infusion
Keywords
Glucose infusion, Liver function, Liver resection, Albumin synthesis, Stable isotopes
Medical subject headings
Hepatic Insufficiency, Liver Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Preoperative glucose infusionOther

    Glucose infusion from 15:00 on the day before the operation until beginning of surgery.

  • Preoperative normal saline infusionOther

    Normal saline infusion from 15:00 on the day before surgery until beginning of the operation.

Study groups in NCT00623662
Study groupRoleWhat they receive
1Active comparatorGlucose infusion.
Receives: Other: Preoperative glucose infusion
2Placebo comparatorNormal saline infusion.
Receives: Other: Preoperative normal saline infusion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of albumin synthesis

    Measured: One day before and one day after surgery

Secondary outcomes (1)
  1. Transthyretin synthesis, fibrinogen synthesis, whole body glucose and protein kinetics

    Measured: One day before and one day after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Feb 2008 (estimated)
  2. Study startFeb 2008
  3. Primary completionMar 2019 (estimated)
  4. Study completionMar 2019 (estimated)

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00623662
Sponsor's protocol ID
GEN-07-075
Other IDs
CIHR 183635
Status last verified
Apr 2018
First submitted
15 Feb 2008
Last updated
3 Apr 2018
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Preoperative glucose infusion and Preoperative normal saline infusion in people with Hepatic Insufficiency and Liver Failure, 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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 3 Apr 2018. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ralph Lattermann, MD PhD (514-934-1934 ext. 35802, ralph.lattermann@muhc.mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of albumin synthesis (time frame: One day before and one day after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 3 Apr 2018; AzTrials last refreshed its copy on 1 Nov 2026.

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