Hospital HyperglycemiaNCT01432093
Intensive Glycemic Management and Outcomes Following Liver Transplantation
A study testing Intensive glycemic management and Conventional management in people with Hospital Hyperglycemia and Post-transplant Hyperglycemia, run by Mayo Clinic at 1 site in United States.
Trial summary
Most people develop high blood sugars following liver transplant that requires treatment with insulin in the hospital, even if they don't have diabetes, due to stress and use of steroid medications. High blood sugar levels can be treated with a hormone that the body makes called insulin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hospital Hyperglycemia, Post-transplant Hyperglycemia
- What is being tested?
- Intensive glycemic management and Conventional management
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Jul 2013
- 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 of age and older
- Undergoing liver transplant or combined liver-kidney transplant
Who cannot join
- Unable to grant informed consent or comply with study procedure
- Allergic to any of the excipients in insulin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intensive Glycemic Management and Outcomes Following Liver Transplantation: A Randomized Controlled Trial
Most people develop high blood sugars following liver transplant that requires treatment with insulin in the hospital, even if they don't have diabetes, due to stress and use of steroid medications. High blood sugar levels can be treated with a hormone that the body makes called insulin. This study is being done to determine if maintaining normal blood sugar levels after transplant for as long as needed while in the hospital results in a lesser incidence of death, infections, transplanted liver rejection or failure or need for rehospitalization within 90 days after transplant.
- Being tested
- Intensive glycemic management, Conventional management
- Keywords
- liver transplant, high blood sugars, hospital hyperglycemia, post-transplant hyperglycemia, post liver transplant, post liver-kidney transplant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive glycemic managementOther
Intravenous insulin infusion, strict dietary intervention, carbohydrate matched subcutaneous insulin therapy. This is a multifaceted approach to achieve strict glucose goals of 90 to 120 mg/dL in the ICU and hospital wards.
Conventional managementOther
Conventional treatment to control hyperglycemia with a target glucose goal of 120 to 150 mg/dL in the ICU and 140 to 180 mg/dL on the hospital floors.
| Study group | Role | What they receive |
|---|---|---|
| Intensive glycemic management | Active comparator | Multifaceted approach to achieve strict glucose goals of 90 to 120 mg/dL in the ICU and hospital wards. Receives: Other: Intensive glycemic management |
| Conventional management | Active comparator | Conventional treatment to control hyperglycemia with a target glucose goal of 120 to 150 mg/dL in the ICU and 140 to 180 mg/dL on the hospital floors. Receives: Other: Conventional management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conduct a randomized controlled trial to compare outcomes with two management strategies to control hospital hyperglycemia in adult patients following liver transplantation.
The primary outcome is a 90 day composite of mortality by any cause, graft failure, rejection, infections, and rehospitalization following liver transplantation.
Measured: 90 days following liver transplantation.
Secondary outcomes (2)
Compare length of stay in the ICU and hospital in the two study groups.
Measured: 90 days following liver transplantation.
Compare the incidence of hypoglycemia in the ICU and hospital in the two study groups.
Measured: 90 days following liver transplantation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2011 (estimated)
- Study startOct 2011
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hospital HyperglycemiaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gunjan Gandhi, Mayo Clinic
- Investigators
- Gunjan Y. Gandhi, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01432093
- Sponsor's protocol ID
- 11-002918
- Status last verified
- Nov 2013
- First submitted
- 7 Sep 2011
- Last updated
- 13 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Glycemic Management and Outcomes Following Liver Transplantation: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01432093
- Acronym / sponsor ID
- 11-002918
- Keywords
- liver transplant, high blood sugars, hospital hyperglycemia, post-transplant hyperglycemia, post liver transplant, post liver-kidney transplant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 12 Sep 2011 (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.
Most people develop high blood sugars following liver transplant that requires treatment with insulin in the hospital, even if they don't have diabetes, due to stress and use of steroid medications. High blood sugar levels can be treated with a hormone that the body makes called insulin. This study is being done to determine if maintaining normal blood sugar levels after transplant for as long as needed while in the hospital results in a lesser incidence of death, infections, transplanted liver rejection or failure or need for rehospitalization within 90 days after transplant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive glycemic management | Active comparator | Other: Intensive glycemic managementMultifaceted approach to achieve strict glucose goals of 90 to 120 mg/dL in the ICU and hospital wards. |
| Conventional management | Active comparator | Other: Conventional managementConventional treatment to control hyperglycemia with a target glucose goal of 120 to 150 mg/dL in the ICU and 140 to 180 mg/dL on the hospital floors. |
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 of age and older
- Undergoing liver transplant or combined liver-kidney transplant
Key exclusion criteria (2 listed)
- Unable to grant informed consent or comply with study procedure
- Allergic to any of the excipients in insulin
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 |
|---|---|---|
| Intensive glycemic managementIntravenous insulin infusion, strict dietary intervention, carbohydrate matched subcutaneous insulin therapy. This is a multifaceted approach to achieve strict glucose goals of 90 to 120 mg/dL in the ICU and hospital wards. | Other | Intensive glycemic management |
| Conventional managementConventional treatment to control hyperglycemia with a target glucose goal of 120 to 150 mg/dL in the ICU and 140 to 180 mg/dL on the hospital floors. | Other | Conventional management |
Primary outcome
Conduct a randomized controlled trial to compare outcomes with two management strategies to control hospital hyperglycemia in adult patients following liver transplantation.
Time frame: 90 days following liver transplantation.
The primary outcome is a 90 day composite of mortality by any cause, graft failure, rejection, infections, and rehospitalization following liver transplantation.
2 secondary outcomes
Compare length of stay in the ICU and hospital in the two study groups.
Time frame: 90 days following liver transplantation.
Compare the incidence of hypoglycemia in the ICU and hospital in the two study groups.
Time frame: 90 days following liver transplantation.
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 13 Nov 2013.
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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.
Gunjan Y. Gandhi, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive glycemic management and Conventional management in people with Hospital Hyperglycemia and Post-transplant Hyperglycemia, run by Mayo Clinic 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 2 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 13 Nov 2013. 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.
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?
Conduct a randomized controlled trial to compare outcomes with two management strategies to control hospital hyperglycemia in adult patients following liver transplantation. (time frame: 90 days following liver transplantation.). 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 13 Nov 2013.