Trial Outcomes & Findings for Use of Methacetin Breath Test to Predict Liver Failure in Patients With Cirrhosis (NCT NCT01157845)
NCT ID: NCT01157845
Last Updated: 2014-05-16
Results Overview
Patient dies of liver-related causes within 1 year of study entry
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
165 participants
Primary outcome timeframe
1 year
Results posted on
2014-05-16
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
165
|
|
Overall Study
COMPLETED
|
130
|
|
Overall Study
NOT COMPLETED
|
35
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
|
Overall Study
Withdrawal by Subject
|
12
|
|
Overall Study
Physician Decision
|
3
|
|
Overall Study
Protocol Violation
|
13
|
|
Overall Study
Study was ended
|
1
|
|
Overall Study
Device malfunction
|
1
|
Baseline Characteristics
Use of Methacetin Breath Test to Predict Liver Failure in Patients With Cirrhosis
Baseline characteristics by cohort
| Measure |
Laboratory Assay
n=165 Participants
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.
|
|---|---|
|
Age, Continuous
|
55.7 years
STANDARD_DEVIATION 10.43 • n=5 Participants
|
|
Sex: Female, Male
Female
|
59 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
106 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
163 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
99 participants
n=5 Participants
|
|
Region of Enrollment
Israel
|
66 participants
n=5 Participants
|
|
Chronic Liver Disease Etiology
Alcoholic Liver Disease
|
22 participants
n=5 Participants
|
|
Chronic Liver Disease Etiology
Cholestatic
|
16 participants
n=5 Participants
|
|
Chronic Liver Disease Etiology
Cryptogenic cirrhosis
|
17 participants
n=5 Participants
|
|
Chronic Liver Disease Etiology
Hepatitis B
|
5 participants
n=5 Participants
|
|
Chronic Liver Disease Etiology
Hepatitis C
|
75 participants
n=5 Participants
|
|
Chronic Liver Disease Etiology
Fatty LIver
|
19 participants
n=5 Participants
|
|
Chronic Liver Disease Etiology
Other
|
11 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearPatient dies of liver-related causes within 1 year of study entry
Outcome measures
| Measure |
Laboratory Assay
n=165 Participants
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.
|
|---|---|
|
Mortality From Liver Failure
|
11 participants
|
SECONDARY outcome
Timeframe: 1 yearPatient experiences complications of liver failure within 1 year of study entry and undergoes liver transplantation
Outcome measures
| Measure |
Laboratory Assay
n=165 Participants
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.
|
|---|---|
|
Liver Transplantation
|
34 participants
|
Adverse Events
Laboratory Assay
Serious events: 107 serious events
Other events: 92 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Laboratory Assay
n=165 participants at risk
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.
|
|---|---|
|
Hepatobiliary disorders
Transplantation
|
20.6%
34/165 • Number of events 34
No breath test related adverse events reported.
|
|
Hepatobiliary disorders
Death
|
6.7%
11/165 • Number of events 11
No breath test related adverse events reported.
|
|
Hepatobiliary disorders
Abdominal pain
|
4.8%
8/165 • Number of events 11
No breath test related adverse events reported.
|
|
Hepatobiliary disorders
Hepatic Encephelopathy
|
3.6%
6/165 • Number of events 13
No breath test related adverse events reported.
|
|
Hepatobiliary disorders
Ascites
|
3.0%
5/165 • Number of events 6
No breath test related adverse events reported.
|
|
Hepatobiliary disorders
GI Bleeding
|
3.0%
5/165 • Number of events 5
No breath test related adverse events reported.
|
|
Surgical and medical procedures
Liver related procedure-TIPS
|
3.0%
5/165 • Number of events 5
No breath test related adverse events reported.
|
|
Hepatobiliary disorders
SBP (spontaneous bacterial peritonitis)
|
4.8%
8/165 • Number of events 13
No breath test related adverse events reported.
|
|
Renal and urinary disorders
Renal failure
|
3.0%
5/165 • Number of events 6
No breath test related adverse events reported.
|
|
Hepatobiliary disorders
Cellulitis
|
1.2%
2/165 • Number of events 2
No breath test related adverse events reported.
|
|
Hepatobiliary disorders
Fluid in respiratory tract
|
0.61%
1/165 • Number of events 1
No breath test related adverse events reported.
|
|
Renal and urinary disorders
Urinary tract infection
|
0.61%
1/165 • Number of events 1
No breath test related adverse events reported.
|
|
Blood and lymphatic system disorders
Hyponatremia
|
1.8%
3/165 • Number of events 3
No breath test related adverse events reported.
|
|
Gastrointestinal disorders
Bowel Resection
|
0.61%
1/165 • Number of events 2
No breath test related adverse events reported.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.61%
1/165 • Number of events 1
No breath test related adverse events reported.
|
|
Respiratory, thoracic and mediastinal disorders
Chest pain
|
1.2%
2/165 • Number of events 2
No breath test related adverse events reported.
|
|
Surgical and medical procedures
Band Ligation Procedure
|
1.2%
2/165 • Number of events 2
No breath test related adverse events reported.
|
|
Surgical and medical procedures
RFA
|
0.61%
1/165 • Number of events 1
No breath test related adverse events reported.
|
|
Infections and infestations
Sepsis
|
4.2%
7/165 • Number of events 9
No breath test related adverse events reported.
|
Other adverse events
| Measure |
Laboratory Assay
n=165 participants at risk
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.
|
|---|---|
|
Gastrointestinal disorders
Diarrhea
|
4.8%
8/165 • Number of events 9
No breath test related adverse events reported.
|
|
General disorders
Hernia
|
1.2%
2/165 • Number of events 3
No breath test related adverse events reported.
|
|
Gastrointestinal disorders
Abdominal Pain
|
3.0%
5/165 • Number of events 16
No breath test related adverse events reported.
|
|
General disorders
Assorted Pains (excluding abdominal)
|
7.9%
13/165 • Number of events 19
No breath test related adverse events reported.
|
|
Gastrointestinal disorders
Vomiting
|
0.61%
1/165 • Number of events 1
No breath test related adverse events reported.
|
|
Musculoskeletal and connective tissue disorders
Hip Fracture
|
0.61%
1/165 • Number of events 1
No breath test related adverse events reported.
|
|
Nervous system disorders
Headaches, Migraines, Dizziness
|
3.6%
6/165 • Number of events 12
No breath test related adverse events reported.
|
|
General disorders
Fatigue
|
1.8%
3/165 • Number of events 3
No breath test related adverse events reported.
|
|
Blood and lymphatic system disorders
Blood related disorders
|
3.0%
5/165 • Number of events 5
No breath test related adverse events reported.
|
|
Infections and infestations
Infections
|
3.0%
5/165 • Number of events 5
No breath test related adverse events reported.
|
|
Psychiatric disorders
Depression
|
1.8%
3/165 • Number of events 3
No breath test related adverse events reported.
|
|
Surgical and medical procedures
Out-patient procedure-Paracentesis
|
6.7%
11/165 • Number of events 64
No breath test related adverse events reported.
|
|
General disorders
Fluid accumulation-edema
|
1.2%
2/165 • Number of events 2
No breath test related adverse events reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignancies
|
1.8%
3/165 • Number of events 3
No breath test related adverse events reported.
|
|
General disorders
Itching
|
3.0%
5/165 • Number of events 5
No breath test related adverse events reported.
|
|
General disorders
Others
|
3.6%
6/165 • Number of events 6
No breath test related adverse events reported.
|
|
Nervous system disorders
Seizure
|
1.2%
2/165 • Number of events 2
No breath test related adverse events reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.61%
1/165 • Number of events 1
No breath test related adverse events reported.
|
|
Musculoskeletal and connective tissue disorders
Hip replacement
|
0.61%
1/165 • Number of events 1
No breath test related adverse events reported.
|
|
Musculoskeletal and connective tissue disorders
Difficulty ambulating
|
1.2%
2/165 • Number of events 2
No breath test related adverse events reported.
|
|
Gastrointestinal disorders
Melena
|
0.61%
1/165 • Number of events 1
No breath test related adverse events reported.
|
|
Gastrointestinal disorders
Other Gastrointestinal Disorders
|
0.61%
1/165 • Number of events 1
No breath test related adverse events reported.
|
|
Psychiatric disorders
Lightheadedness
|
0.61%
1/165 • Number of events 1
No breath test related adverse events reported.
|
|
Psychiatric disorders
Anxiety
|
0.61%
1/165 • Number of events 1
No breath test related adverse events reported.
|
|
Psychiatric disorders
Suicidal thoughts
|
0.61%
1/165 • Number of events 1
No breath test related adverse events reported.
|
|
Psychiatric disorders
Other psychiatric disorders
|
0.61%
1/165 • Number of events 1
No breath test related adverse events reported.
|
|
General disorders
Pleural Effusion
|
0.61%
1/165 • Number of events 1
No breath test related adverse events reported.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60