Trial · NCT01565941
Heart And Lung Failure - Pediatric INsulin Titration Trial
NCT01565941, Phase 3, Completed, Boston Children's Hospital; results first posted 2017-12-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Heart And Lung Failure - Pediatric INsulin Titration Trial. Trials, record NCT01565941. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01565941
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Heart And Lung Failure - Pediatric INsulin Titration Trial
- NCT number
- NCT01565941
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 713 participants, actual
- Lead sponsor
- Boston Children's Hospital
- Conditions
- Heart Failure, Respiratory Failure
- Interventions
- Insulin, Insulin
- First posted
- 2012-03-29
- Last updated
- 2022-07-25
- Results first posted
- 2017-12-11
Source ClinicalTrials.gov
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | ICU-Free Days | Study day 28 | 28-day hospital mortality-adjusted ICU length of stay. |
| Secondary | 90-day Hospital Mortality | 90 days after randomization | In order to enable direct comparisons between data gathered in HALF-PINT and the prior adult NICE-SUGAR trial, we will collect data on 90-day hospital mortality. |
| Secondary | 28-day Hospital Mortality | 28 days after randomization | We will collect data on 28-day hospital mortality. |
| Secondary | Accumulation of Multiple Organ Dysfunction Syndrome (MODS) | 28 days after randomization | Accumulation of MODS during the 28 days following randomization will be measured. MODS is defined as the concurrent dysfunction of two or more organ systems (e.g., acute lung injury and renal failure). The clinical relevance of MODS as a surrogate outcome measure is well recognized in the intensive care community, and there is a clear relationship between the number of dysfunctional organ systems and the risk of death in critically ill children. |
| Secondary | Ventilator-Free Days | 28 days following randomization | Ventilator-free days during the 28 days following randomization encompasses both reduction in the duration of ventilation and improvement in mortality. The end of the subject's duration of ventilation is defined as the date/time of extubation for subjects who are intubated, or the date/time of the discontinuation of mechanical ventilation for subjects with tracheostomy. |
| Secondary | Developmental Neurobehavioral Outcomes: VABS-II Composite | One year after ICU course | Reliable, reproducible measures of adaptive functioning, behavior and quality of life will be used to determine outcomes at baseline (CBCL, PedsQL) and at one year after ICU discharge (Vineland-II, CBCL, PedsQL). The goal of baseline data collection is to assess pre-ICU health and quality of life. The results of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) are reported. Scores range from 20-160, with higher scores being better. |
| Secondary | Participants With Device-Related or Non-Device Related Nosocomial Infection | Up to 48 hours after ICU discharge | We will use Centers for Disease Control's (CDC) most recently published definitions for the following nosocomial infections attributable to the ICU stay: total bloodstream infections including Central Venous Line (CVL)-associated bloodstream infections (BSI), respiratory tract infections including ventilator-associated pneumonias, urinary tract infections, and wound infections that occur in the ICU or within 48 hours of discharge to the non-ICU inpatient unit. |
| Secondary | Incidence of Catheter-Associated Bloodstream Infection | Up to 48 hours after ICU discharge | We will use Centers for Disease Control's (CDC) most recently published definition for the following nosocomial infection attributable to the ICU stay: Central Venous Line (CVL)-associated bloodstream infections (BSI) that occur in the ICU or within 48 hours of discharge to the non-ICU inpatient unit. This device-related infection will be counted per 1,000 device days. |
| Secondary | Incidence of Catheter-Associated Urinary Tract Infection | Up to 48 hours after ICU discharge | We will use Centers for Disease Control's (CDC) most recently published definition for the following nosocomial infection attributable to the ICU stay: urinary tract infections that occur in the ICU or within 48 hours of discharge to the non-ICU inpatient unit. This device-related infection will be counted per 1,000 device days. |
| Secondary | Incidence of Ventilator-Associated Pneumonia | Up to 48 hours after ICU discharge | We will use Centers for Disease Control's (CDC) most recently published definition for the following nosocomial infection attributable to the ICU stay: respiratory tract infections including ventilator-associated pneumonias that occur in the ICU or within 48 hours of discharge to the non-ICU inpatient unit. This device-related infection will be counted per 1,000 device days. |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 registered outcomesOutcomes21
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | ICU-Free Days | Study day 28 | Days | MEDIAN | |
| SECONDARY | 90-day Hospital Mortality | 90 days after randomization | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | 28-day Hospital Mortality | 28 days after randomization | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Accumulation of Multiple Organ Dysfunction Syndrome (MODS) | 28 days after randomization | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Ventilator-Free Days | 28 days following randomization | Days | MEDIAN | |
| SECONDARY | Developmental Neurobehavioral Outcomes: VABS-II Composite | One year after ICU course | Score on a scale | MEAN | |
| SECONDARY | Participants With Device-Related or Non-Device Related Nosocomial Infection | Up to 48 hours after ICU discharge | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Incidence of Catheter-Associated Bloodstream Infection | Up to 48 hours after ICU discharge | Infections/1000 CVC days | NUMBER | |
| SECONDARY | Incidence of Catheter-Associated Urinary Tract Infection | Up to 48 hours after ICU discharge | Infections/1000 bladder catheter days | NUMBER | |
| SECONDARY | Incidence of Ventilator-Associated Pneumonia | Up to 48 hours after ICU discharge | Infections/1000 ventilator days | NUMBER |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 outcomesResults by group42
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| ICU-Free Days | Tight Glycemic Control 1 (TGC-1) | 20 | Inter-Quartile Range 1.0 to 24.2 | Days | |
| ICU-Free Days | Tight Glycemic Control 2 (TGC-2) | 19.4 | Inter-Quartile Range 7.1 to 23.9 | Days | |
| 90-day Hospital Mortality | Tight Glycemic Control 1 (TGC-1) | 52 | Participants | ||
| 90-day Hospital Mortality | Tight Glycemic Control 2 (TGC-2) | 40 | Participants | ||
| 28-day Hospital Mortality | Tight Glycemic Control 1 (TGC-1) | 47 | Participants | ||
| 28-day Hospital Mortality | Tight Glycemic Control 2 (TGC-2) | 32 | Participants | ||
| Accumulation of Multiple Organ Dysfunction Syndrome (MODS) | Tight Glycemic Control 1 (TGC-1) | 326 | Participants | ||
| Accumulation of Multiple Organ Dysfunction Syndrome (MODS) | Tight Glycemic Control 2 (TGC-2) | 324 | Participants | ||
| Ventilator-Free Days | Tight Glycemic Control 1 (TGC-1) | 21.8 | Inter-Quartile Range 8.4 to 25.0 | Days | |
| Ventilator-Free Days | Tight Glycemic Control 2 (TGC-2) | 20.9 | Inter-Quartile Range 11.9 to 24.4 | Days |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 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 1 (TGC-1) | 360 | |
| Overall Study | STARTED | Tight Glycemic Control 2 (TGC-2) | 353 | |
| Overall Study | COMPLETED | Tight Glycemic Control 1 (TGC-1) | 349 | |
| Overall Study | COMPLETED | Tight Glycemic Control 2 (TGC-2) | 349 | |
| Overall Study | NOT COMPLETED | Tight Glycemic Control 1 (TGC-1) | 11 | |
| Overall Study | NOT COMPLETED | Tight Glycemic Control 2 (TGC-2) | 4 |
Source ClinicalTrials.gov
Adverse events12
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 (< 2.5 mmol/L) | Endocrine disorders | Tight Glycemic Control 1 (TGC-1) | 76 | 349 | |
| other | Hypokalemia (< 2.5 mmol/L) | Endocrine disorders | Tight Glycemic Control 2 (TGC-2) | 64 | 349 | |
| other | New seizure | Nervous system disorders | Tight Glycemic Control 1 (TGC-1) | 5 | 349 | |
| other | New seizure | Nervous system disorders | Tight Glycemic Control 2 (TGC-2) | 10 | 349 | |
| other | Health-care associated infection | Infections and infestations | Tight Glycemic Control 1 (TGC-1) | 12 | 349 | |
| other | Health-care associated infection | Infections and infestations | Tight Glycemic Control 2 (TGC-2) | 4 | 349 | |
| other | Infection with positive culture | Infections and infestations | Tight Glycemic Control 1 (TGC-1) | 29 | 349 | |
| other | Infection with positive culture | Infections and infestations | Tight Glycemic Control 2 (TGC-2) | 34 | 349 | |
| serious | Severe hypoglycemia (BG < 40 mg/dL) Unrelated to insulin administration | Endocrine disorders | Tight Glycemic Control 1 (TGC-1) | 5 | 349 | |
| serious | Severe hypoglycemia (BG < 40 mg/dL) Unrelated to insulin administration | Endocrine disorders | Tight Glycemic Control 2 (TGC-2) | 6 | 349 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tight Glycemic Control 1 (TGC-1) | ||
| Total, all-cause mortality | Tight Glycemic Control 2 (TGC-2) | ||
| Total, other adverse events | Tight Glycemic Control 1 (TGC-1) | 122 | 349 |
| Total, other adverse events | Tight Glycemic Control 2 (TGC-2) | 112 | 349 |
| Total, serious adverse events | Tight Glycemic Control 1 (TGC-1) | 18 | 349 |
| Total, serious adverse events | Tight Glycemic Control 2 (TGC-2) | 7 | 349 |
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 |
|---|---|---|---|---|---|
| U01HL107681 | HALF-PINT: Heart and Lung Failure - Pediatric INsulin Titration trial - CCC | AGUS, MICHAEL SD; NADKARNI, VINAY M | BOSTON CHILDREN'S HOSPITAL | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE | 2011 to 2016 |
Source NIH RePORTER
Trial comparisons10
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Tight Glycemic Control 1 (TGC-1) vs Tight Glycemic Control 2 (TGC-2): Participants With Severe Hypoglycemia (<40 mg/dL), Related to Insulin Infusion (Insulin Algorithm Safety) | Trial comparisons |
| Tight Glycemic Control 1 (TGC-1) vs Tight Glycemic Control 2 (TGC-2): Participants With Any Hypoglycemia (<60 mg/dL), Unrelated to Insulin Infusion (Insulin Algorithm Safety) | Trial comparisons |
| Tight Glycemic Control 1 (TGC-1) vs Tight Glycemic Control 2 (TGC-2): 90-day Hospital Mortality | Trial comparisons |
| Tight Glycemic Control 1 (TGC-1) vs Tight Glycemic Control 2 (TGC-2): 28-day Hospital Mortality | Trial comparisons |
| Tight Glycemic Control 1 (TGC-1) vs Tight Glycemic Control 2 (TGC-2): Participants With Device-Related or Non-Device Related Nosocomial Infection | Trial comparisons |
| Tight Glycemic Control 1 (TGC-1) vs Tight Glycemic Control 2 (TGC-2): Accumulation of Multiple Organ Dysfunction Syndrome (MODS) | Trial comparisons |
| Tight Glycemic Control 1 (TGC-1) vs Tight Glycemic Control 2 (TGC-2): Participants With Hypokalemia (<2.5 mmol/L) | Trial comparisons |
| Tight Glycemic Control 1 (TGC-1) vs Tight Glycemic Control 2 (TGC-2): Participants With Severe Hypoglycemia (<40 mg/dL), Unrelated to Insulin Infusion (Insulin Algorithm Safety) | Trial comparisons |
| Tight Glycemic Control 1 (TGC-1) vs Tight Glycemic Control 2 (TGC-2): Participants With Any Hypoglycemia (<60 mg/dL), Related to Insulin Infusion (Insulin Algorithm Safety) | Trial comparisons |
| Tight Glycemic Control 1 (TGC-1) vs Tight Glycemic Control 2 (TGC-2): 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/NCT01565941
GET https://conductscience.org/api/trials/v1/NCT01565941/registered?page=2