Trial · NCT00443599
SPECS: Safe Pediatric Euglycemia in Cardiac Surgery
NCT00443599, Not applicable, Completed, Boston Children's Hospital; results first posted 2014-03-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. SPECS: Safe Pediatric Euglycemia in Cardiac Surgery. Trials, record NCT00443599. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00443599
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- SPECS: Safe Pediatric Euglycemia in Cardiac Surgery
- NCT number
- NCT00443599
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 989 participants, actual
- Lead sponsor
- Boston Children's Hospital
- Conditions
- Heart Defects, Congenital, Hyperglycemia
- Interventions
- Insulin, Usual Care
- First posted
- 2007-03-06
- Last updated
- 2022-07-25
- Results first posted
- 2014-03-10
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of Nosocomial Infections in the Cardiac ICU | Measured during participant's ICU stay, a median duration of 3 days. | Nosocomial infections that are attributable to the subject's stay in the Cardiac ICU, according to Center for Disease Control-defined criteria. These definitions are extensive and cannot be accurately condensed to fit within this space. Current CDC/NHSN criteria may be accessed through this URL: https://www.cdc.gov/nhsn/pdfs/pscmanual/17pscnosinfdef\_current.pdf. |
| Secondary | Cardiac Index (CI) | Day 2 (day after cardiopulmonary bypass surgery). | Cardiac index is a measure of cardiac function, relating the cardiac output from the left ventricle in one minute to body surface area. It is calculated using the Fick principle, using oxygen consumption measured with a metabolic cart, hemoglobin levels, and the difference between arterial and superior vena cava oxygen saturation measured by co-oximetry. |
| Secondary | Duration of ICU Stay | The duration of cardiac ICU stay was evaluated from the date of postoperative cardiac ICU admission until the date of cardiac ICU discharge or date of death from any cause, whichever came first, assessed up to 30 days. | Duration of ICU stay spans from post-operative cardiac ICU admission to cardiac ICU discharge. |
| Secondary | Duration of Hospital Stay | The duration of hospital stay was evaluated from the day of postoperative cardiac ICU admission until the day of hospital discharge or day of death from any cause, whichever came first, assessed up to 30 days. | Duration of hospital stay spans from post-operative cardiac ICU admission to hospital discharge. |
| Secondary | Duration of Endotracheal Intubation | The duration of endotracheal intubation (mechanical ventilation) was evaluated from the day of postoperative cardiac ICU admission until the day of extubation or day of death from any cause, whichever came first, assessed up to 30 days. | Duration of endotracheal intubation spans from endotracheal tube intubation/initiation of mechanical ventilation to endotracheal tube extubation. |
| Secondary | Mortality at Hospital Discharge. | Mortality at hospital discharge (In-hospital mortality) was evaluated on the day of hospital discharge or day of death from any cause, whichever came first (no upper limit). | Mortality is assessed at hospital discharge and at 30 days. |
| Secondary | Mortality at 30 Days. | Measured at 30 days. | Mortality is assessed at hospital discharge and at 30 days. If the participant is discharged from the hospital prior to 30 days, status is determined by a follow-up phone call to the family. |
| Secondary | Cardiac Function | The duration of vasoactive support was evaluated from the day of postoperative cardiac ICU admission until the last day of vasoactive support or day of death from any cause, whichever came first, assessed up to 30 days. | Cardiac function is assessed by duration of vasoactive support. |
| Secondary | Immune Function | Post-operative day 7. | Immune function is assessed by C-reactive protein (CRP) on post-operative day 7. |
| Secondary | Endocrine Function | Measured during participant's ICU stay on Day 7. | Endocrine function is assessed by total triiodothyronine (T3) on post-operative day 7. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Incidence of Nosocomial Infections in the Cardiac ICU | Measured during participant's ICU stay, a median duration of 3 days. | infections / 1000 pt days | NUMBER | |
| SECONDARY | Cardiac Index (CI) | Day 2 (day after cardiopulmonary bypass surgery). | This outcome (using indirect calorimetry) was not available at the Michigan site, and not captured in Boston participants A) who had been extubated or were receiving only pressure support ventilation, B) without a properly placed catheter allowing for a true mixed venous sample or C) for whom equipment malfunction precluded an accurate measurement. | liters/min/m^2 | MEDIAN |
| SECONDARY | Duration of ICU Stay | The duration of cardiac ICU stay was evaluated from the date of postoperative cardiac ICU admission until the date of cardiac ICU discharge or date of death from any cause, whichever came first, assessed up to 30 days. | Days | MEDIAN | |
| SECONDARY | Duration of Hospital Stay | The duration of hospital stay was evaluated from the day of postoperative cardiac ICU admission until the day of hospital discharge or day of death from any cause, whichever came first, assessed up to 30 days. | Days | MEDIAN | |
| SECONDARY | Duration of Endotracheal Intubation | The duration of endotracheal intubation (mechanical ventilation) was evaluated from the day of postoperative cardiac ICU admission until the day of extubation or day of death from any cause, whichever came first, assessed up to 30 days. | Days | MEDIAN | |
| SECONDARY | Mortality at Hospital Discharge. | Mortality at hospital discharge (In-hospital mortality) was evaluated on the day of hospital discharge or day of death from any cause, whichever came first (no upper limit). | Participants | NUMBER | |
| SECONDARY | Mortality at 30 Days. | Measured at 30 days. | This outcome was not measured for participants lost to follow-up at 30 days post cardiac surgery. | Participants | NUMBER |
| SECONDARY | Cardiac Function | The duration of vasoactive support was evaluated from the day of postoperative cardiac ICU admission until the last day of vasoactive support or day of death from any cause, whichever came first, assessed up to 30 days. | Days | MEDIAN | |
| SECONDARY | Immune Function | Post-operative day 7. | Participants analyzed include those with adequate access for blood sampling, C-reactive protein (CRP) drawn on post-operative day 7 and successful processing and preparation of samples, | mg/dL | MEDIAN |
| SECONDARY | Endocrine Function | Measured during participant's ICU stay on Day 7. | Thyroid hormones were assayed only if the participant remained in the cardiac ICU and there was central venous or arterial access for blood sampling. | ng/dL | MEDIAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Incidence of Nosocomial Infections in the Cardiac ICU | Tight Glycemic Control | 8.6 | infections / 1000 pt days | ||
| Incidence of Nosocomial Infections in the Cardiac ICU | Standard Care | 9.9 | infections / 1000 pt days | ||
| Cardiac Index (CI) | Tight Glycemic Control | 2.0 | Inter-Quartile Range 1.1 to 2.8 | liters/min/m^2 | |
| Cardiac Index (CI) | Standard Care | 1.8 | Inter-Quartile Range 1.2 to 2.6 | liters/min/m^2 | |
| Duration of ICU Stay | Tight Glycemic Control | 3 | Inter-Quartile Range 2 to 6 | Days | |
| Duration of ICU Stay | Standard Care | 3 | Inter-Quartile Range 2 to 6 | Days | |
| Duration of Hospital Stay | Tight Glycemic Control | 8 | Inter-Quartile Range 5 to 15 | Days | |
| Duration of Hospital Stay | Standard Care | 7 | Inter-Quartile Range 5 to 13 | Days | |
| Duration of Endotracheal Intubation | Tight Glycemic Control | 3 | Inter-Quartile Range 2 to 5 | Days | |
| Duration of Endotracheal Intubation | Standard Care | 2 | Inter-Quartile Range 1 to 5 | Days |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tight Glycemic Control | 496 | |
| Overall Study | STARTED | Standard Care | 493 | |
| Overall Study | COMPLETED | Tight Glycemic Control | 490 | |
| Overall Study | COMPLETED | Standard Care | 490 | |
| Overall Study | NOT COMPLETED | Tight Glycemic Control | 6 | |
| Overall Study | NOT COMPLETED | Standard Care | 3 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Hypokalemia (K < 2.0 mmol/L) | Endocrine disorders | Insulin | 15 | 490 | |
| other | Hypokalemia (K < 2.0 mmol/L) | Endocrine disorders | Usual Care | 19 | 490 | |
| serious | Severe hypoglycemia (BG < 40 mg/dL) | Endocrine disorders | Insulin | 16 | 490 | |
| serious | Severe hypoglycemia (BG < 40 mg/dL) | Endocrine disorders | Usual Care | 5 | 490 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Insulin | ||
| Total, all-cause mortality | Usual Care | ||
| Total, other adverse events | Insulin | 15 | 490 |
| Total, other adverse events | Usual Care | 19 | 490 |
| Total, serious adverse events | Insulin | 16 | 490 |
| Total, serious adverse events | Usual Care | 5 | 490 |
Source ClinicalTrials.gov
Papers11
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01HL088448 | SPECS: Safe Pediatric Euglycemia in Cardiac Surgery | AGUS, MICHAEL SD | BOSTON CHILDREN'S HOSPITAL | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE | 2007 to 2011 |
Source NIH RePORTER
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Tight Glycemic Control vs Standard Care: Mortality at Hospital Discharge. | Trial comparisons |
| Tight Glycemic Control vs Standard Care: Mortality at 30 Days. | Trial comparisons |
| Insulin vs Usual Care: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00443599
GET https://conductscience.org/api/trials/v1/NCT00443599/results?page=2