## Protocol Section
### Identification Module
**NCT ID:** NCT00725179

**Brief Title:** Treatment of Acetaminophen Toxicity With N-acetylcysteine

**Official Title:** Treatment of Acetaminophen Toxicity With Intravenous vs Oral N-acetylcysteine: A Retrospective Review

#### Organization Study ID Info
**ID:** APAP & NAC
#### Organization
**Class:** OTHER
**Full Name:** Akron Children's Hospital
### Status Module
#### Completion Date
**Date:** 2008-10

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2011-09-09

**Type:** ESTIMATED

**Last Update Submit Date:** 2011-09-08

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2008-09

**Type:** ACTUAL

#### Start Date
**Date:** 2008-08

**Status Verified Date:** 2011-09

#### Study First Post Date
**Date:** 2008-07-30
**Type:** ESTIMATED
**Study First Submit Date:** 2008-07-25
**Study First Submit QC Date:** 2008-07-29
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Akron Children's Hospital

#### Responsible Party

**Investigator Affiliation:** Akron Children's Hospital

**Investigator Full Name:** Martha Blackford

**Investigator Title:** PharmD

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Retrospective chart review of patients who received N-acetylcysteine for APAP toxicity to assess length of oral vs IV treatment and overall healthcare costs.

### Conditions Module

**Conditions:**

- Acetaminophen Toxicity

**Keywords:**

- acetaminophen toxicity

- n-acetylcysteine

- liver toxicity

### Design Module

#### Design Info

**Observational Model:** CASE_ONLY

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 130

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients receiving oral NAC treatment

**Label:** 1

#### Arm Group 2

**Description:** Patients receiving IV NAC treatment

**Label:** 2

### Outcomes Module

#### Primary Outcomes

**Measure:** Duration of oral vs IV NAC treatment in hours

**Time Frame:** From admission to discharge

#### Secondary Outcomes

**Measure:** Overall healthcare costs associated with IV vs Oral NAC treatment

**Time Frame:** From admission to discharge

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Admitted to CHMCA between June 1, 2004 to May 31, 2008 with a qualifying ICD-9 diagnosis code for the following APAP overdose situations; poisoning, accidental, suicide attempt, therapeutic use, assault, and undetermined (965.4, E850.4, E950.0, E935.4, E962.0, E980.0)
* Serum APAP concentrations ≥ 150 g/mL at 4 hours or a serum concentration above the possible hepatotoxic line on the Rumack-Matthew's nomogram if obtained \> 4 hours post ingestion
* Between the ages of 0-21 years

Exclusion Criteria:

* Serum APAP concentrations are not actually documented
* Patient did not receive oral or IV NAC treatment
* Patient has a preexisting liver disease such as cirrhosis or hepatitis C
* Patient \> 21 years of age

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

**Study Population:** Pediatric and adolescent patients with acetaminophen toxicity

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Akron

**Country:** United States

**Facility:** Children's Hospital Medical Center of Akron

**State:** Ohio

**Zip:** 44703

#### Overall Officials

**Official 1:**

**Affiliation:** CHMCA

**Name:** Martha Blackford, PharmD

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** Heard KJ. Acetylcysteine for acetaminophen poisoning. N Engl J Med. 2008 Jul 17;359(3):285-92. doi: 10.1056/NEJMct0708278.

**PMID:** 18635433

**Citation:** Culley CM, Krenzelok EP. A clinical and pharmacoeconomic justification for intravenous acetylcysteine: a US perspective. Toxicol Rev. 2005;24(2):131-43. doi: 10.2165/00139709-200524020-00007.

**PMID:** 16180933

**Citation:** Kanter MZ. Comparison of oral and i.v. acetylcysteine in the treatment of acetaminophen poisoning. Am J Health Syst Pharm. 2006 Oct 1;63(19):1821-7. doi: 10.2146/ajhp060050.

**PMID:** 16990628

**Citation:** Blackford MG, Felter T, Gothard MD, Reed MD. Assessment of the clinical use of intravenous and oral N-acetylcysteine in the treatment of acute acetaminophen poisoning in children: a retrospective review. Clin Ther. 2011 Sep;33(9):1322-30. doi: 10.1016/j.clinthera.2011.08.005. Epub 2011 Sep 3.

**PMID:** 21890206

## Derived Section

### Intervention Browse Module - Browse Branches

- Abbrev: Antipy

- Name: Antipyretics

- Abbrev: Analg

- Name: Analgesics

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Hemat

- Name: Hematinics

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: Resp

- Name: Respiratory System Agents

### Intervention Browse Module - Browse Leaves

- ID: M2340

- Name: Acetaminophen

- Relevance: LOW

- As Found: Unknown

- ID: M11110

- Name: Liver Extracts

- Relevance: LOW

- As Found: Unknown

- ID: M3475

- Name: Acetylcysteine

- Relevance: LOW

- As Found: Unknown

- ID: M244107

- Name: N-monoacetylcystine

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
