Trial · NCT00248625
N-acetylcysteine in Non-Acetaminophen Pediatric Acute Liver Failure
NCT00248625, Phase 3, Completed, University of Pittsburgh; results first posted 2016-07-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. N-acetylcysteine in Non-Acetaminophen Pediatric Acute Liver Failure. Trials, record NCT00248625. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00248625
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- N-acetylcysteine in Non-Acetaminophen Pediatric Acute Liver Failure
- NCT number
- NCT00248625
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 184 participants, actual
- Lead sponsor
- University of Pittsburgh
- Conditions
- Acute Liver Failure, Hepatic Encephalopathy
- Interventions
- N-acetylcysteine, Placebo
- First posted
- 2005-11-04
- Last updated
- 2016-07-28
- Results first posted
- 2016-07-28
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Survival | One year following randomization | Spontaneous survival without transplant plus survival following transplantation |
| Secondary | Spontaneous Recovery | One year following randomization | Survival without liver transplantation |
| Secondary | Cumulative Percent Incidence of Transplantation by 1 Year | Within 1 year of randomization | |
| Secondary | Length of Hospital Stay | Randomization to hospital discharge | |
| Secondary | Categorized Length of ICU Stay | Within 7 days of randomization | The length of ICU stay was categorized as number of days in ICU within 7 days of randomization, unless participant either died or received an LTx within this time period. Special categories were created for these cases. |
| Secondary | Number of Organ Systems Failing | Within 7 days of randomization | |
| Secondary | Highest Coma Grade of Hepatic Encephalopathy | Within 7 days of randomization | West Haven Criteria for hepatic encephalopathy (Grade 0 - IV ) is used for participants \> 3 year of age. Coma grade IV indicates a participant who is comatose , with no reflexes, is decerebrate and has abnormal EEG changes with very slow delta activity. For participants less than 3 years the Whittington Scale was used. The Whittington scale does not use EEG changes and has only 3 levels, early (grades I and II), Mid (III) with somnolence, stupor, combativeness and Late (IV) for participants who are comatose with absent reflexes and decerebrate or decorticate posturing. |
| Secondary | Infectious Complication | Within 7 days of randomization |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Survival | One year following randomization | All participants who were enrolled in the study were included in the survival analysis | Participants | NUMBER |
| SECONDARY | Spontaneous Recovery | One year following randomization | All participants enrolled in study | participants | NUMBER |
| SECONDARY | Cumulative Percent Incidence of Transplantation by 1 Year | Within 1 year of randomization | percentage of participants | NUMBER | |
| SECONDARY | Length of Hospital Stay | Randomization to hospital discharge | All participants enrolled in study with hospital stay information, 2 participants (1 in each arm) did not have hospital discharge information. | days | MEDIAN |
| SECONDARY | Categorized Length of ICU Stay | Within 7 days of randomization | participants | NUMBER | |
| SECONDARY | Number of Organ Systems Failing | Within 7 days of randomization | participants | NUMBER | |
| SECONDARY | Highest Coma Grade of Hepatic Encephalopathy | Within 7 days of randomization | All enrolled participants where coma grade could be assessed. Four participants (two in each randomization arm) could not have coma grade assessed during the 7 days after randomization. | participants | NUMBER |
| SECONDARY | Infectious Complication | Within 7 days of randomization | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group50
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Survival | N-acetylcysteine (NAC) | 68 | Participants | ||
| Survival | Placebo | 76 | Participants | ||
| Spontaneous Recovery | N-acetylcysteine (NAC) | 33 | participants | ||
| Spontaneous Recovery | Placebo | 49 | participants | ||
| Cumulative Percent Incidence of Transplantation by 1 Year | N-acetylcysteine (NAC) | 45 | percentage of participants | ||
| Cumulative Percent Incidence of Transplantation by 1 Year | Placebo | 35 | percentage of participants | ||
| Length of Hospital Stay | N-acetylcysteine (NAC) | 103 | Inter-Quartile Range 13 to 103 | days | |
| Length of Hospital Stay | Placebo | 21 | Inter-Quartile Range 9 to 103 | days | |
| Categorized Length of ICU Stay | N-acetylcysteine (NAC) | 0 days | 29 | participants | |
| Categorized Length of ICU Stay | Placebo | 0 days | 34 | participants |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 92 | |
| Overall Study | STARTED | N-acetylcysteine (NAC) | 92 | |
| Overall Study | COMPLETED | Placebo | 92 | |
| Overall Study | COMPLETED | N-acetylcysteine (NAC) | 90 | |
| Overall Study | NOT COMPLETED | Placebo | 0 | |
| Overall Study | NOT COMPLETED | N-acetylcysteine (NAC) | 2 |
Source ClinicalTrials.gov
Adverse events44
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 | Infection | Infections and infestations | N-acetylcysteine (NAC) | 11 | 92 | |
| other | Infection | Infections and infestations | Placebo | 8 | 92 | |
| other | Rash | Skin and subcutaneous tissue disorders | N-acetylcysteine (NAC) | 4 | 92 | |
| other | Rash | Skin and subcutaneous tissue disorders | Placebo | 2 | 92 | |
| other | Bronchospasm | Respiratory, thoracic and mediastinal disorders | N-acetylcysteine (NAC) | 1 | 92 | |
| other | Bronchospasm | Respiratory, thoracic and mediastinal disorders | Placebo | 0 | 92 | |
| other | Arrhythmia | Cardiac disorders | N-acetylcysteine (NAC) | 1 | 92 | |
| other | Arrhythmia | Cardiac disorders | Placebo | 4 | 92 | |
| other | Aspiration | Respiratory, thoracic and mediastinal disorders | N-acetylcysteine (NAC) | 1 | 92 | |
| other | Aspiration | Respiratory, thoracic and mediastinal disorders | Placebo | 0 | 92 |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | N-acetylcysteine (NAC) | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | N-acetylcysteine (NAC) | 19 | 92 |
| Total, other adverse events | Placebo | 16 | 92 |
| Total, serious adverse events | N-acetylcysteine (NAC) | 5 | 92 |
| Total, serious adverse events | Placebo | 4 | 92 |
Source ClinicalTrials.gov
Papers7
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 |
|---|---|---|---|---|---|
| U01DK072146 | A Multi-Center Group to Study Acute Liver Failure in Children | SQUIRES, ROBERT H | UNIVERSITY OF PITTSBURGH AT PITTSBURGH | NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES | 2005 to 2014 |
Source NIH RePORTER
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| N-acetylcysteine (NAC) vs Placebo: Survival | Trial comparisons |
| N-acetylcysteine (NAC) vs Placebo: Infectious Complication | Trial comparisons |
| N-acetylcysteine (NAC) vs Placebo: Spontaneous Recovery | Trial comparisons |
| N-acetylcysteine (NAC) vs Placebo: 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/NCT00248625
GET https://conductscience.org/api/trials/v1/NCT00248625/results?page=2