Cardiac SurgeryPhase 2NCT01398722
Effect of Intensive Insulin Therapy on Clinical Prognosis of Infants Undergoing Cardiac Surgery
A Phase 2 study testing Intensive insulin therapy and Conventional insulin therapy in people with Cardiac Surgery, run by Xijing Hospital at 1 site in China.
Trial summary
The investigators sought to determine whether intensive insulin therapy can improve prognosis of infants undergoing cardiac surgery. Read more about this study
- Who is it for?
- Ages Up to 3 years
- Conditions the study is for
- Cardiac Surgery
- What is being tested?
- Intensive insulin therapy and Conventional insulin therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteChina
- Study dates
- Aug 2011to Jul 2012
- Phase
- Phase 2
- 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 Up to 3 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants underwent cardiac surgery with cardiopulmonary bypass
Who cannot join
- Therapy restricted upon admission
- Preoperative liver or kidney disease or dysfunction
- Preoperative coagulation disorder
- Palliative operation or a second operation
- Type 1 diabetes
- Type 2 diabetes
Trial locations and contacts
1 site in 1 country.
Chunhu Gu, MD contact
China1 site
Xijing Hospital
Xi'an, Shaanxi, 710032
Chunhu Gu, MD, guchunhu@fmmu.edu.cn
Chunhu Gu, MD
About this study
Official title: Study of the Relationship Between Intensive Insulin Therapy and Clinical Prognosis in Infants Undergoing Cardiac Surgery
The investigators sought to determine whether intensive insulin therapy can improve prognosis of infants undergoing cardiac surgery.
Read the detailed description
Previous studies showed that tight blood glucose control with insulin during intensive care reduced morbidity and mortality of surgical and medical intensive care patients. Blood sugar control with intravenous insulin may improve prognosis of patients undergoing cardiac surgery. It is not clear what the best insulin regimen is or what is the best blood sugar target in these patients. So far, most of researches have focused on adult patients but little on infants. The current prospective, randomized, controlled study will assess the impact of intensive insulin therapy on the outcome of infants undergoing cardiac surgery. On admission, patients will be randomly assigned to either strict normalization of blood glucose ( 110-150 mg/dl) with intensive insulin therapy or the conventional approach, in which blood glucose levels are maintained between 150 and 180 mg/dl.
- Conditions
- Cardiac Surgery
- Being tested
- Intensive insulin therapy, Conventional insulin therapy
- Keywords
- cardiac surgery, prognosis, intensive insulin therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive insulin therapyOther
Titration of the IV insulin rate for glucose goal 110-150 mg/dL
Conventional insulin therapyOther
Titration of the IV insulin rate for glucose goal 150-180 mg/dl
| Study group | Role | What they receive |
|---|---|---|
| Intensive insulin therapy | Active comparator | Intensive insulin therapy(Blood glucose target: 110-150 mg/dL) Receives: Other: Intensive insulin therapy |
| Conventional insulin therapy | Active comparator | Conventional insulin therapy(Blood glucose target: 150-180 mg/dl) Receives: Other: Conventional insulin therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause mortality
Measured: one year
Secondary outcomes (8)
Biochemical markers of myocardial injury(troponin and creatine kinase MB)
Measured: average 1 month during the hospitalization
Acute renal failure
Measured: average 1 month during the hospitalization
Respiratory failure
Measured: average 1 month during the hospitalization
ICU and hospital length of stay, and ICU readmissions
Measured: average 1 month during the hospitalization
Stroke and reversible ischemic neurologic deficit
Measured: average 1 month during the hospitalization
Cardiac Index
Measured: average 1 month during the hospitalization
Inotropic Scores
Measured: average 1 month during the hospitalization
Perioperative complications
Perioperative complications including sternal wound infection (deep and superficial), bacteremia, pneumonia, and major cardiovascular events (acute myocardial infarction, congestive heart failure, and cardiac arrhythmias
Measured: average 1 month during the hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2011 (estimated)
- Study startAug 2011
- Primary completionJul 2012 (estimated)
- Study completionJul 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Dinhhua Yi, MD, Study chair, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01398722
- Sponsor's protocol ID
- Guch-012
- Status last verified
- Jul 2011
- First submitted
- 11 Jul 2011
- Last updated
- 20 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Relationship Between Intensive Insulin Therapy and Clinical Prognosis in Infants Undergoing Cardiac Surgery
- ClinicalTrials.gov ID
- NCT01398722
- Acronym / sponsor ID
- Guch-012
- Conditions
- Cardiac Surgery
- Keywords
- cardiac surgery, prognosis, intensive insulin therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Jul 2012 (estimated)
- Study completion
- Jul 2012 (estimated)
- First posted
- 20 Jul 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.
The investigators sought to determine whether intensive insulin therapy can improve prognosis of infants undergoing cardiac surgery.
Detailed description
Previous studies showed that tight blood glucose control with insulin during intensive care reduced morbidity and mortality of surgical and medical intensive care patients. Blood sugar control with intravenous insulin may improve prognosis of patients undergoing cardiac surgery. It is not clear what the best insulin regimen is or what is the best blood sugar target in these patients. So far, most of researches have focused on adult patients but little on infants. The current prospective, randomized, controlled study will assess the impact of intensive insulin therapy on the outcome of infants undergoing cardiac surgery. On admission, patients will be randomly assigned to either strict normalization of blood glucose ( 110-150 mg/dl) with intensive insulin therapy or the conventional approach, in which blood glucose levels are maintained between 150 and 180 mg/dl.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive insulin therapy | Active comparator | Other: Intensive insulin therapyIntensive insulin therapy(Blood glucose target: 110-150 mg/dL) |
| Conventional insulin therapy | Active comparator | Other: Conventional insulin therapyConventional insulin therapy(Blood glucose target: 150-180 mg/dl) |
Who may qualify
- Ages
- Up to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Infants underwent cardiac surgery with cardiopulmonary bypass
Key exclusion criteria (6 listed)
- Therapy restricted upon admission
- Preoperative liver or kidney disease or dysfunction
- Preoperative coagulation disorder
- Palliative operation or a second operation
- Type 1 diabetes
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 insulin therapyTitration of the IV insulin rate for glucose goal 110-150 mg/dL | Other | Intensive insulin therapy |
| Conventional insulin therapyTitration of the IV insulin rate for glucose goal 150-180 mg/dl | Other | Conventional insulin therapy |
Primary outcome
All cause mortality
Time frame: one year
8 secondary outcomes
Biochemical markers of myocardial injury(troponin and creatine kinase MB)
Time frame: average 1 month during the hospitalization
Acute renal failure
Time frame: average 1 month during the hospitalization
Respiratory failure
Time frame: average 1 month during the hospitalization
ICU and hospital length of stay, and ICU readmissions
Time frame: average 1 month during the hospitalization
Stroke and reversible ischemic neurologic deficit
Time frame: average 1 month during the hospitalization
Cardiac Index
Time frame: average 1 month during the hospitalization
Inotropic Scores
Time frame: average 1 month during the hospitalization
Perioperative complications
Time frame: average 1 month during the hospitalization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2011.
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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.
Chunhu Gu, MD contact
Dinhhua Yi, MD study chair
Xijing Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intensive insulin therapy and Conventional insulin therapy in people with Cardiac Surgery, run by Xijing Hospital at 1 site in China.
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 1 inclusion and 6 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 20 Jul 2011. 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 China. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Chunhu Gu, MD (guchunhu@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All cause mortality (time frame: one year). 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 20 Jul 2011.