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| Name | Class |
|---|---|
| Meridian Bioscience, Inc. | INDUSTRY |
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The methacetin breath test (MBT) is a non-invasive liver function test which measures the ability of the liver to metabolize a tracer dose of a compound to carbon dioxide, which is exhaled. The study hypothesis is that measurement of the MBT will allow earlier detection of a decline in liver function in patients with cirrhosis who are awaiting liver transplantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laboratory assay | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BreathID (Methacetin breath test) | Device | 13C-labeled methacetin (75 mg) is given to the patient by mouth in a small volume of water, and expired 13C-labeled carbon dioxide is measured from a nasal cannula. |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality From Liver Failure | Patient dies of liver-related causes within 1 year of study entry | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Liver Transplantation | Patient experiences complications of liver failure within 1 year of study entry and undergoes liver transplantation | 1 year |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard T Stravitz, MD | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henry Ford Health System | Detroit | Michigan | 48202 | United States | ||
| Medical University of South Carolina |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15679768 | Background | Braden B, Faust D, Sarrazin U, Zeuzem S, Dietrich CF, Caspary WF, Sarrazin C. 13C-methacetin breath test as liver function test in patients with chronic hepatitis C virus infection. Aliment Pharmacol Ther. 2005 Jan 15;21(2):179-85. doi: 10.1111/j.1365-2036.2005.02317.x. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Laboratory Assay | BreathID (Methacetin breath test): 13C-labeled methacetin (75 mg) is given to the patient by mouth in a small volume of water, and expired 13C-labeled carbon dioxide is measured from a nasal cannula. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All chronic liver disease patients with clinically proven cirrhosis and candidates for liver transplant.
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| ID | Title | Description |
|---|---|---|
| BG000 | Laboratory Assay | BreathID (Methacetin breath test): 13C-labeled methacetin (75 mg) is given to the patient by mouth in a small volume of water, and expired 13C-labeled carbon dioxide is measured from a nasal cannula. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Mortality From Liver Failure | Patient dies of liver-related causes within 1 year of study entry | Posted | Number | participants | 1 year |
|
|
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No breath test related adverse events reported.
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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 | Laboratory Assay | BreathID (Methacetin breath test): 13C-labeled methacetin (75 mg) is given to the patient by mouth in a small volume of water, and expired 13C-labeled carbon dioxide is measured from a nasal cannula. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Transplantation | Hepatobiliary disorders | Non-systematic Assessment | Patients in this trial are candidates for liver transplant. When there is a sudden change for the worse in their condition, they may be prioritized for transplantation/ |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| R. Todd Stravitz | Virginia Commonwealth University | 804-828-8514 | rstravit@vcu.edu |
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| ID | Term |
|---|---|
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| Charleston |
| South Carolina |
| 29425 |
| United States |
| Virginia Commonwealth University Medical Center | Richmond | Virginia | 23298 | United States |
| Hadassah Medical Center | Jerusalem | Israel | 91120 | Israel |
| Protocol Violation |
|
| Study was ended |
|
| Device malfunction |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Chronic Liver Disease Etiology | Number | participants |
|
|
| Secondary | Liver Transplantation | Patient experiences complications of liver failure within 1 year of study entry and undergoes liver transplantation | Posted | Number | participants | 1 year |
|
|
|
| 107 |
| 165 |
| 92 |
| 165 |
|
| Death | Hepatobiliary disorders | Non-systematic Assessment | Some patients waiting for a liver transplant will die before they find a matching liver |
|
| Abdominal pain | Hepatobiliary disorders | Non-systematic Assessment | Indirectly related- to- liver ailments may occur in patients with advanced liver disease. |
|
| Hepatic Encephelopathy | Hepatobiliary disorders | Non-systematic Assessment | Lack in full cognitive abilities is common in patients with advanced liver disease. |
|
| Ascites | Hepatobiliary disorders | Non-systematic Assessment | Ascites ( collection of fluid) is common in patients with advanced liver disease |
|
| GI Bleeding | Hepatobiliary disorders | Non-systematic Assessment | GI bleeding (varices) is common in patients with advanced liver disease |
|
| Liver related procedure-TIPS | Surgical and medical procedures | Non-systematic Assessment | The patients with advanced liver disease are occasionally hospitalized for preventative treatments such as TIPS (Transjugular intrahepatic portosystemic shunt) |
|
| SBP (spontaneous bacterial peritonitis) | Hepatobiliary disorders | Non-systematic Assessment | Common in advanced cirrhotics |
|
| Renal failure | Renal and urinary disorders | Non-systematic Assessment | The lack of liver functionality in cirrhotic patients may lead to certain severe events such as renal failure |
|
| Cellulitis | Hepatobiliary disorders | Non-systematic Assessment |
|
| Fluid in respiratory tract | Hepatobiliary disorders | Non-systematic Assessment |
|
| Urinary tract infection | Renal and urinary disorders | Non-systematic Assessment |
|
| Hyponatremia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Bowel Resection | Gastrointestinal disorders | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Chest pain | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Band Ligation Procedure | Surgical and medical procedures | Non-systematic Assessment | The patients with advanced liver disease are occasionally hospitalized for preventative treatments such as band ligation |
|
| RFA | Surgical and medical procedures | Non-systematic Assessment | The patients with advanced liver disease are occasionally hospitalized for preventative treatments such as RFA (radio frequency ablation) |
|
| Sepsis | Infections and infestations | Non-systematic Assessment | The lack of liver functionality in cirrhotic patients may lead to certain severe events such as sepsis |
|
| Hernia | General disorders | Non-systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| Assorted Pains (excluding abdominal) | General disorders | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| Hip Fracture | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Headaches, Migraines, Dizziness | Nervous system disorders | Non-systematic Assessment |
|
| Fatigue | General disorders | Non-systematic Assessment |
|
| Blood related disorders | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Infections | Infections and infestations | Non-systematic Assessment | Various infections not liver related and not specified |
|
| Depression | Psychiatric disorders | Non-systematic Assessment |
|
| Out-patient procedure-Paracentesis | Surgical and medical procedures | Non-systematic Assessment |
|
| Fluid accumulation-edema | General disorders | Non-systematic Assessment |
|
| Malignancies | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Itching | General disorders | Non-systematic Assessment |
|
| Others | General disorders | Non-systematic Assessment |
|
| Seizure | Nervous system disorders | Non-systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Hip replacement | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Difficulty ambulating | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Melena | Gastrointestinal disorders | Non-systematic Assessment |
|
| Other Gastrointestinal Disorders | Gastrointestinal disorders | Non-systematic Assessment | Non-specified disorders |
|
| Lightheadedness | Psychiatric disorders | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | Non-systematic Assessment |
|
| Suicidal thoughts | Psychiatric disorders | Non-systematic Assessment |
|
| Other psychiatric disorders | Psychiatric disorders | Non-systematic Assessment | Unspecified psychiatric disorders |
|
| Pleural Effusion | General disorders | Non-systematic Assessment |
|
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