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| ID | Type | Description | Link |
|---|---|---|---|
| 4KL2TR001063-04 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| MaineHealth | OTHER |
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This is an unblinded, single center, randomized study of infants with congenital heart disease undergoing cardiopulmonary bypass surgery, randomized to either the delayed rewarming intervention or to the standard of care (strict normothermia).
Control Group:
The congenital heart surgery will be performed according to usual practice with the degree of intra-operative hypothermia determined by the cardiothoracic surgeon based on the anticipated complexity of the case. Following completion of the surgical procedure, the infant will be rapidly rewarmed on CPB at a rate of 0.2 to 0.3°C per minute to a normothermic temperature of 36.5°C. Infants in this group will be given a single weight-based 15 mg/kg dose of intravenous Tylenol in the operating room (OR) by the anesthesiologist as the chest is being closed. The infant will be transported to the Pediatric Intensive Care Unit (PICU) for routine post-operative monitoring. If the infant develops a fever, ice packs will be applied to the axilla and groin per usual routine and removed once the fever has abated.
Experimental group:
Partial rewarming will occur on CPB to 35°C. During the last hour of surgery, the infant's temperature will be maintained at 35°C while the chest is closed by using a BairHugger and lowering the room temperature. Transfusions of packed red blood cells, fresh frozen plasma and cryoprecipitate will not be automatically warmed. Infants will be given a single 15 mg/kg dose of IV Tylenol in the OR. The infant will be transported to the PICU at 35°C and placed on the temperature-regulating blanket. The infant will be incrementally rewarmed with increases in temperature of 0.3°C every 2 hours for 6 hours, then 0.2°C every 2 hours for 6 hours to the goal temperature of 36.5°C. Once the infant is stable, EEG will be performed for 48 hours to screen for seizures. The PI will interpret the EEG every 6-8 hours. The infant will remain on the blanket at 36.5°C for another 12 hours. The blanket and esophageal temperature probe will then be removed a total of 24 hours after surgery was completed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Strict Normothermia | Active Comparator | Patients will be rewarmed to 36.5 degrees centigrade in the operating room and maintained here by conventional means in the PICU. |
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| Delayed Rewarming | Experimental | Patient will be rewarmed to 35.0 degrees centigrade in the operating room, then slowly rewarmed to normal physiologic temperature over 12 hours by using a servo-controlled cooling blanket. Normothermia will be maintained by the cooling blanket for an additional 12 hours. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Strict normothermia | Other |
| ||
| Delayed Rewarming |
| Measure | Description | Time Frame |
|---|---|---|
| Infants With Elevated s100b and NSE | In a population of infants with congenital heart disease undergoing cardiopulmonary bypass surgery, does delayed rewarming administered during the 12 hours after surgery, compared to standard care, decrease brain injury as measured by levels of serum biomarkers of brain injury, s100b and neuron specific enolase during the four days after surgery? | 4 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | In a population of infants with congenital heart disease undergoing cardiopulmonary bypass surgery, is there evidence for increased frequency of severe, moderate or other adverse events in the delayed rewarming group compared to the standard of care group? | 4 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexa K Craig, MD, MSc | Assistant Professor of Pediatrics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maine Medical Center | Portland | Maine | 04102 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Strict Normothermia | Patients will be rewarmed to 36.5 degrees centigrade in the operating room and maintained here by conventional means in the PICU. Strict normothermia |
| FG001 | Delayed Rewarming | Patient will be rewarmed to 35.0 degrees centigrade in the operating room, then slowly rewarmed to normal physiologic temperature (36.5) over 12 hours by using a servo-controlled cooling blanket. Normothermia will be maintained by the cooling blanket for an additional 12 hours. Delayed Rewarming: Use of the servo-controlled cooling blanket for delayed rewarming to target temperature. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Strict Normothermia | Patients will be rewarmed to 36.5 degrees centigrade in the operating room and maintained here by conventional means in the PICU. Strict normothermia |
| BG001 | Delayed Rewarming |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Infants With Elevated s100b and NSE | In a population of infants with congenital heart disease undergoing cardiopulmonary bypass surgery, does delayed rewarming administered during the 12 hours after surgery, compared to standard care, decrease brain injury as measured by levels of serum biomarkers of brain injury, s100b and neuron specific enolase during the four days after surgery? | Laboratory storage and transportation issues resulted in less than expected number of viable specimens that could be analyzed at all 5 time points. | Posted | Count of Participants | Participants | 4 days |
|
Until 48 hours post surgery.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Strict Normothermia | Patients will be rewarmed to 36.5 degrees centigrade in the operating room and maintained here by conventional means in the PICU. Strict normothermia |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ECMO after surgery | Cardiac disorders | Systematic Assessment | Patient unable to wean from bypass following surgery. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alexa Craig, MD | Maine Medical Center | 207-396-6920 | craiga@mmc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 31, 2017 | Feb 24, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Use of the servo-controlled cooling blanket for delayed rewarming to target temperature. |
|
| Physician Decision |
|
Patient will be rewarmed to 35.0 degrees centigrade in the operating room, then slowly rewarmed to normal physiologic temperature (36.5) over 12 hours by using a servo-controlled cooling blanket. Normothermia will be maintained by the cooling blanket for an additional 12 hours.
Delayed Rewarming: Use of the servo-controlled cooling blanket for delayed rewarming to target temperature.
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Trisomy 21 | Count of Participants | Participants |
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| Delayed Rewarming |
Patient will be rewarmed to 35.0 degrees centigrade in the operating room, then slowly rewarmed to normal physiologic temperature (36.5) over 12 hours by using a servo-controlled cooling blanket. Normothermia will be maintained by the cooling blanket for an additional 12 hours. Delayed Rewarming: Use of the servo-controlled cooling blanket for delayed rewarming to target temperature. |
|
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| Secondary | Number of Participants With Adverse Events | In a population of infants with congenital heart disease undergoing cardiopulmonary bypass surgery, is there evidence for increased frequency of severe, moderate or other adverse events in the delayed rewarming group compared to the standard of care group? | Posted | Count of Participants | Participants | 4 days |
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| 0 |
| 12 |
| 3 |
| 12 |
| 0 |
| 12 |
| EG001 | Delayed Rewarming | Patient will be rewarmed to 35.0 degrees centigrade in the operating room, then slowly rewarmed to normal physiologic temperature (36.5) over 12 hours by using a servo-controlled cooling blanket. Normothermia will be maintained by the cooling blanket for an additional 12 hours. Delayed Rewarming: Use of the servo-controlled cooling blanket for delayed rewarming to target temperature. | 1 | 10 | 2 | 10 | 0 | 10 |
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| CPR after surgery | Cardiac disorders | Systematic Assessment |
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| Return to Operating Room | Cardiac disorders | Systematic Assessment |
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| Stroke or Seizure | Nervous system disorders | Systematic Assessment |
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