Liver TransplantPhase 4NCT00780026
Intraoperative Glucose Control in Liver Transplant
A Phase 4 study testing insulin in people with Liver Transplant, run by University of Michigan at 1 site in United States.
Trial summary
The goal of the proposed study is to evaluate the effectiveness of intraoperative, strict glycemic control to improve survival and infection rates following liver transplantation in a randomized, prospective trial.Primary objective: To determine if strict intraoperative blood glucose control, when compared to standard… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Liver Transplant
- What is being tested?
- insulin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Sep 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients ≥ 18 years old undergoing liver transplantation
- Patients willing and capable of giving written informed consent for study participation
Who cannot join
- Multi-organ transplant recipients
- Patients receiving a liver incompatible with A, B or O blood types
- HIV infected patients
- Recipients of an organ from an HIV+ donor
- Patients with severe coexisting disease or presenting with any unstable medical condition which could affect the study objectives
- Patients with a co-existing alcoholic disease who have not been abstinent for at least 6 month immediately prior to transplantation and are not expected to be able to remain abstinent after transplantation
Show all 11Show fewer
- Patients who are unlikely to comply with the study requirements or unable to give informed consent
- Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer or if such therapy is to be instituted posttransplantation
- Patients transplanted for hepatocellular carcinoma exceeding 3 nodules or with nodule diameter larger than 5 cm
- History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadatropin (hCG) laboratory test (> 5 milli-International units (mIU/ml)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect Of Intraoperative Strict Glycemic Control During Liver Transplantation On Postoperative Morbidity And Mortality
The goal of the proposed study is to evaluate the effectiveness of intraoperative, strict glycemic control to improve survival and infection rates following liver transplantation in a randomized, prospective trial.Primary objective: To determine if strict intraoperative blood glucose control, when compared to standard intraoperative glycemic control, improves 1-year recipient survival and decreases surgical complications, including infections, following liver transplantation.
Read the detailed description
Approximately 2.1 million patients in the United States acquire infections during medical care every year. For example, 9%-30% patients who undergo surgery acquire nosocomial infections, which increase mortality and morbidity over that expected normally expected and increase the cost of care by several billion dollars. Studies have shown that controlling high blood glucose levels dramatically improves the recovery of critically ill patients after surgery, most notably decreasing the risk of infection. The advantage of strict glycemic control in the critically ill patient is now well accepted, and the Institute for Healthcare Improvement and Surviving Sepsis Campaign set glycemic control as part of the post-operative sepsis management bundle.
Few studies have investigated the role of strict glycemic control during surgery itself. Liver transplantation is a good model for studying glucose control as hyperglycemia almost always occurs and the incidence of infection is higher than with other surgical procedures. We performed a retrospective review of 184 consecutive adult liver recipients in which intra-operative blood glucose levels were measured and treated with insulin. Recipients with strict glycemic control were compared to those with poor control for differences in donor and recipient demographics, intra-operative blood glucose concentrations, intra-operative insulin administered, immunosuppression, post-operative complications, and mortality. Poor glycemic control was associated with a significantly increased rate of infection during the first 30 days post-operatively (48% vs. 33%, P=0.05) and 1-year mortality was significantly increased for those recipients with poor intra-operative glucose control (21.9% vs. 8.8%; P = 0.05). These data along with the post-operative studies, suggest that the post-transplant mortality rate may potentially be decreased by nearly 50% at 1 year and underscore the need for this to be confirmed in a prospective trial.
The goal of this study is to prospectively evaluate the outcomes of liver transplant recipients to either strict glucose control (goal of 80-110 mg/dl) or the current standard of care (goal of between 180 and 200 mg/dl). The specific aim of this study is to determine if strict intra-operative blood glucose control, improves 1-year recipient survival and decreases surgical complications, including infections, following liver transplantation. The rates of infection at 30 days after surgery and health at one year post- surgery will be compared. The frequency of other common post-operation complications will also be studied. The proposed study has the potential to have an impact on the intra-operative management of all liver transplant recipients.
- Conditions
- Liver Transplant
- Being tested
- insulin
- Keywords
- liver, transplant, blood sugar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
insulinDrug
bolus or infusion 80 to 110 mg/dl
| Study group | Role | What they receive |
|---|---|---|
| Strict Glycemic Control | Experimental | strict glycemic control (80 to 110 mg/dl) Receives: Drug: insulin |
| Standard of Care Control | No intervention | standard of care insulin dosing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infection Rates
Number of participants who sustained an infection after surgery
Measured: 30 days
Number of Participants With One Year Survival Post Transplant
Measured: 12 months
Secondary outcomes (5)
Hospital Length of Stay
Measured: 12 months
Participants Who Required Postoperative Blood Transfusion Within 3 Days in the ICU
Requirements for blood transfusion counted as a binary variable yes/no per participant
Measured: 12 months
Number of Participants With a Need for Hemodialysis
Number of people who had renal failure in the year following liver transplant and needing hemodialysis to support it;
Measured: 12 months post surgery
Number of Participants With Biliary Complications
Number of participants who experienced bile leak or biliary Stricture
Measured: 12 months
Number of Participants With Venous Thrombotic Complications
Number of participants who were diagnosed with portal vein thrombosis post surgery
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2008 (estimated)
- Study startJul 2008
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver TransplantStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shawn J. Pelletier, MD, University of Michigan
- Investigators
- Shawn Pelletier, MD, Principal investigator, Universitry of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00780026
- Sponsor's protocol ID
- HUM00016106
- Status last verified
- Dec 2018
- First submitted
- 22 Oct 2008
- Last updated
- 15 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
Publications
Kumar SS, Pelletier SJ, Shanks A, Thompson A, Sonnenday CJ, Picton P. Intraoperative glycemic control in patients undergoing Orthotopic liver transplant: a single center prospective randomized study. BMC Anesthesiol. 2020 Jan 4;20(1):3. doi: 10.1186/s12871-019-0918-0.
PubMed 31901245
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Intraoperative Strict Glycemic Control During Liver Transplantation On Postoperative Morbidity And Mortality
- ClinicalTrials.gov ID
- NCT00780026
- Acronym / sponsor ID
- HUM00016106
- Conditions
- Liver Transplant
- Keywords
- liver, transplant, blood sugar
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 24 Oct 2008 (estimated)
- Results
- Posted 6 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of the proposed study is to evaluate the effectiveness of intraoperative, strict glycemic control to improve survival and infection rates following liver transplantation in a randomized, prospective trial.Primary objective: To determine if strict intraoperative blood glucose control, when compared to standard intraoperative glycemic control, improves 1-year recipient survival and decreases surgical complications, including infections, following liver transplantation.
Detailed description
Approximately 2.1 million patients in the United States acquire infections during medical care every year. For example, 9%-30% patients who undergo surgery acquire nosocomial infections, which increase mortality and morbidity over that expected normally expected and increase the cost of care by several billion dollars. Studies have shown that controlling high blood glucose levels dramatically improves the recovery of critically ill patients after surgery, most notably decreasing the risk of infection. The advantage of strict glycemic control in the critically ill patient is now well accepted, and the Institute for Healthcare Improvement and Surviving Sepsis Campaign set glycemic control as part of the post-operative sepsis management bundle.
Few studies have investigated the role of strict glycemic control during surgery itself. Liver transplantation is a good model for studying glucose control as hyperglycemia almost always occurs and the incidence of infection is higher than with other surgical procedures. We performed a retrospective review of 184 consecutive adult liver recipients in which intra-operative blood glucose levels were measured and treated with insulin. Recipients with strict glycemic control were compared to those with poor control for differences in donor and recipient demographics, intra-operative blood glucose concentrations, intra-operative insulin administered, immunosuppression, post-operative complications, and mortality. Poor glycemic control was associated with a significantly increased rate of infection during the first 30 days post-operatively (48% vs. 33%, P=0.05) and 1-year mortality was significantly increased for those recipients with poor intra-operative glucose control (21.9% vs. 8.8%; P = 0.05). These data along with the post-operative studies, suggest that the post-transplant mortality rate may potentially be decreased by nearly 50% at 1 year and underscore the need for this to be confirmed in a prospective trial.
The goal of this study is to prospectively evaluate the outcomes of liver transplant recipients to either strict glucose control (goal of 80-110 mg/dl) or the current standard of care (goal of between 180 and 200 mg/dl). The specific aim of this study is to determine if strict intra-operative blood glucose control, improves 1-year recipient survival and decreases surgical complications, including infections, following liver transplantation. The rates of infection at 30 days after surgery and health at one year post- surgery will be compared. The frequency of other common post-operation complications will also be studied. The proposed study has the potential to have an impact on the intra-operative management of all liver transplant recipients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Strict Glycemic Control | Experimental | Drug: insulinstrict glycemic control (80 to 110 mg/dl) |
| Standard of Care Control | No intervention | –standard of care insulin dosing |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female patients ≥ 18 years old undergoing liver transplantation
- Patients willing and capable of giving written informed consent for study participation
Key exclusion criteria (11 listed)
- Multi-organ transplant recipients
- Patients receiving a liver incompatible with A, B or O blood types
- HIV infected patients
- Recipients of an organ from an HIV+ donor
- Patients with severe coexisting disease or presenting with any unstable medical condition which could affect the study objectives
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 |
|---|---|---|
| insulinbolus or infusion 80 to 110 mg/dl | Drug | Strict Glycemic Control |
Primary outcome
Infection Rates
Time frame: 30 days
Number of participants who sustained an infection after surgery
Number of Participants With One Year Survival Post Transplant
Time frame: 12 months
5 secondary outcomes
Hospital Length of Stay
Time frame: 12 months
Participants Who Required Postoperative Blood Transfusion Within 3 Days in the ICU
Time frame: 12 months
Number of Participants With a Need for Hemodialysis
Time frame: 12 months post surgery
Number of Participants With Biliary Complications
Time frame: 12 months
Number of Participants With Venous Thrombotic Complications
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31901245Kumar SS, Pelletier SJ, Shanks A, Thompson A, Sonnenday CJ, Picton P. Intraoperative glycemic control in patients undergoing Orthotopic liver transplant: a single center prospective randomized study. BMC Anesthesiol. 2020 Jan 4;20(1):3. doi: 10.1186/s12871-019-0918-0.
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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.
Shawn Pelletier, MD principal investigator
Universitry of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing insulin in people with Liver Transplant, run by University of Michigan at 1 site in United States.
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 11 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 15 Jan 2019. 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Infection Rates (time frame: 30 days). The study lists 2 primary outcomes in all. 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 NCT00780026, which also lists 1 linked publication.
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 15 Jan 2019.