Cardiac SurgeryPhase 2NCT01398709
Effect of Rewarming Rate During Cardiopulmonary Bypass on Clinical Prognosis of Infants Undergoing Cardiac Surgery
A Phase 2 study testing Slow rewarming strategy and Fast rewarming strategy in people with Cardiac Surgery and Cardiopulmonary Bypass, run by Xijing Hospital at 1 site in China.
Trial summary
The purpose of this study is to investigate the relationship between rewarming rate during cardiopulmonary bypass and clinical prognosis in 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, Cardiopulmonary Bypass, Rewarming Rate
- What is being tested?
- Slow rewarming strategy and Fast rewarming strategy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Aug 2011to Sep 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 who had underwent cardiac surgery with cardiopulmonary bypass
Who cannot join
- Preoperative liver or kidney disease or dysfunction
- Preoperative coagulation disorder
- Palliative operation or a second operation
- Above 3 years
Trial locations and contacts
1 site in 1 country.
Chunhu Gu, MD contact
China1 site
Xijing Hospital
Xi'an, Shannxi, 710032
Chunhu Gu, MD, guchunhu@fmmu.edu.cn
Chunhu Gu, MD
About this study
Official title: Study of the Relationship Between Rewarming Rate During Cardiopulmonary Bypass and Clinical Prognosis in Infants Undergoing Cardiac Surgery
The purpose of this study is to investigate the relationship between rewarming rate during cardiopulmonary bypass and clinical prognosis in infants undergoing cardiac surgery.
Read the detailed description
There have been many studies indicating that rewarming management plays an important role in cardiac surgery. The purpose of this study is to investigate the relationship between rewarming rate during cardiopulmonary bypass and clinical prognosis in patients undergoing cardiac surgery. Infants undergoing cardiac surgery with cardiopulmonary bypass are randomly assigned to either a slow rewarming strategy (0.24 degrees C/min) or a fast rewarming strategy (0.5 degrees C/min).
- Conditions
- Cardiac Surgery, Cardiopulmonary Bypass, Rewarming Rate
- Being tested
- Slow rewarming strategy, Fast rewarming strategy
- Keywords
- Cardiopulmonary Bypass, Prognosis, Cardiac Surgery, Rewarming Rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Slow rewarming strategyOther
Rewarming rate:0.24 degrees C/min.
Fast rewarming strategyOther
Rewarming rate:0.5 degrees C/min.
| Study group | Role | What they receive |
|---|---|---|
| Slow rewarming strategy | Active comparator | Slow rewarming strategy (0.24 degrees C/min) Receives: Other: Slow rewarming strategy |
| Fast rewarming strategy | Active comparator | Fast rewarming strategy (0.5 degrees C/min) Receives: Other: Fast rewarming strategy |
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 (7)
Acute renal failure
Measured: one month
Respiratory failure
Measured: one month
ICU and hospital length of stay, and ICU readmissions
Measured: one month
Stroke and reversible ischemic neurologic deficit
Measured: one month
Measures of inflammation
Measures of inflammation (C-reactive protein, TNF-alpha; IL-6) and oxidative stress markers
Measured: one month
Biochemical markers of myocardial necrosis
Biochemical markers of myocardial necrosis（troponin and creatine kinase MB）
Measured: one month
Perioperative complications
Perioperative complications include sternal wound infection (deep and superficial), bacteremia, pneumonia, and major cardiovascular events (acute myocardial infarction, congestive heart failure, and cardiac arrhythmias.
Measured: one month
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 completionSep 2012 (estimated)
- Study completionSep 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Dinghua Yi, MD, Study chair, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01398709
- Sponsor's protocol ID
- Guch-011
- 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 Rewarming Rate During Cardiopulmonary Bypass and Clinical Prognosis in Infants Undergoing Cardiac Surgery
- ClinicalTrials.gov ID
- NCT01398709
- Acronym / sponsor ID
- Guch-011
- Conditions
- Cardiac Surgery, Cardiopulmonary Bypass, Rewarming Rate
- Keywords
- Cardiopulmonary Bypass, Prognosis, Cardiac Surgery, Rewarming Rate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Sep 2012 (estimated)
- Study completion
- Sep 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 purpose of this study is to investigate the relationship between rewarming rate during cardiopulmonary bypass and clinical prognosis in infants undergoing cardiac surgery.
Detailed description
There have been many studies indicating that rewarming management plays an important role in cardiac surgery. The purpose of this study is to investigate the relationship between rewarming rate during cardiopulmonary bypass and clinical prognosis in patients undergoing cardiac surgery. Infants undergoing cardiac surgery with cardiopulmonary bypass are randomly assigned to either a slow rewarming strategy (0.24 degrees C/min) or a fast rewarming strategy (0.5 degrees C/min).
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Slow rewarming strategy | Active comparator | Other: Slow rewarming strategySlow rewarming strategy (0.24 degrees C/min) |
| Fast rewarming strategy | Active comparator | Other: Fast rewarming strategyFast rewarming strategy (0.5 degrees C/min) |
Who may qualify
- Ages
- Up to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Infants who had underwent cardiac surgery with cardiopulmonary bypass
Key exclusion criteria (4 listed)
- Preoperative liver or kidney disease or dysfunction
- Preoperative coagulation disorder
- Palliative operation or a second operation
- Above 3 years
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 |
|---|---|---|
| Slow rewarming strategyRewarming rate:0.24 degrees C/min. | Other | Slow rewarming strategy |
| Fast rewarming strategyRewarming rate:0.5 degrees C/min. | Other | Fast rewarming strategy |
Primary outcome
all cause mortality
Time frame: one year
7 secondary outcomes
Acute renal failure
Time frame: one month
Respiratory failure
Time frame: one month
ICU and hospital length of stay, and ICU readmissions
Time frame: one month
Stroke and reversible ischemic neurologic deficit
Time frame: one month
Measures of inflammation
Time frame: one month
Biochemical markers of myocardial necrosis
Time frame: one month
Perioperative complications
Time frame: one month
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
Dinghua 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 Slow rewarming strategy and Fast rewarming strategy in people with Cardiac Surgery and Cardiopulmonary Bypass, 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 4 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.