- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01658982
Cardiopulmonary Exercise Testing in Cirrhotic Patients: a Pilot Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Subjects: 10 patients ≥40 years of age with cirrhotic end-stage liver disease undergoing liver transplantation evaluation at Mayo Clinic, Rochester, MN. Patients who require multi-organ transplant, or who have non-cirrhotic liver disease (neuroendocrine, amyloidosis, etc.) will be excluded. Each subject will undergo both standard CPET and modified 3 minute step test.
Exercise testing. Subjects will perform both tests during one visit to the cardiopulmonary research lab. A 30-60 minute period between tests will given. 5 patients will perform submaximal stress testing first and 5 will perform the full CPET first.
CPET: Patients will perform a 6 minute cardiopulmonary exercise test using the recumbent stationary bicycle facilitated by the co-investigators at the St Mary's cardiopulmonary exercise laboratory. Standard 12-lead electrocardiograms will be obtained at rest, each minute during exercise, and for at least five minutes during the recovery phase; blood pressure will be measured using a standard cuff sphygmomanometer. Minute ventilation (VE), breathing frequency (fR), tidal volume (VT), oxygen consumption (VO2), CO2 production (VCO2), RER, and end-tidal CO2 (PETCO2) will be obtained breath-by-breath and averaged over a 30-second period at rest and the last 30 seconds of each minute during exercise. In addition, heart rate (HR) and oxygen saturation (SaO2) will be obtained continuously using pulse oximetry. From these data, derived variables such as the VE/VCO2 ratio, oxygen pulse (VO2/HR) and an index of pulmonary capacitance (O2 pulse /[1/PETCO2]) are calculated at rest and during exercise. Ventilatory efficiency slopes (VE/VCO2 slope) [VE liter/min _ m (VCO2, liter/min) _ b], where m _ VE/VCO2 slope, and oxygen uptake efficiency slopes (OUES) [VO2, liter/min _ m (log10VE) _ b], where m _ OUES, are calculated using all exercise data points via least squares linear regression.
Modified 3 minute step test: Each participant will perform a sub-maximal exercise test that consists of 2 minutes of resting baseline, 3 minutes of step exercise, and 1 minute of recovery. Breathing pattern, gas exchange (as described above), and heart rate will be monitored using a simplified gas analysis system (SHAPE Medical Systems, Inc, St. Paul, MN). Submaximal testing will be defined by respiratory exchange ratio (RER), and perceived exertion (RPE). An exercise RER of 0.9 and RPE of 12 to 13 on the Borg scale (range, 6 to 20) is considered to be a sub-maximal level. At the end of the first & second minute of step exercise, RER and RPE will be recorded and the step rate adjusted (a patient with a low RER (< 0.8) and RPE (< 8) would increase the step rate for the second minute, whereas a patient with a higher RER (> 0.85) and RPE (> 11) would maintain the same step rate). On completion of the 3-minute step exercise, recovery data will be collected for 1 minute.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- listed for liver transplantation with end stage liver disease
Exclusion Criteria:
- patients listed for liver transplant without end stage liver disease
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
cirrhotic patients
cardiopulmonary exercise testing
|
3 minute step test compared to 6 minute bicycle test
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
respiratory exchange ratio
Time Frame: during test
|
during test
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12-004215
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on End Stage Liver Disease
-
University of ZurichUniversity Ghent; University Hospital of Sao Paulo, BrazilCompleted
-
Vanderbilt University Medical CenterEnrolling by invitationEnd Stage Liver DIseaseUnited States
-
Virginia Commonwealth UniversityCompletedEnd Stage Liver DIseaseUnited States
-
Guy's and St Thomas' NHS Foundation TrustKing's College LondonCompletedEnd-stage Liver DiseaseUnited Kingdom
-
Proteonomix, Inc.University of Medicine and Dentistry of New Jersey; NumodaUnknownEnd Stage Liver DIseaseUnited States
-
RenJi HospitalNot yet recruitingEnd Stage Liver DIsease
-
Mayo ClinicRecruiting
-
University of Sao PauloFundação de Amparo à Pesquisa do Estado de São PauloCompleted
-
Huashan HospitalRecruiting
-
Beijing Chao Yang HospitalUnknownLiver Transplantation | End Stage Liver DIseaseChina
Clinical Trials on cardiopulmonary exercise testing
-
Eduardo Tibirica, MD, PhDCompletedCoronary Artery Disease | Surgery--ComplicationsBrazil
-
McGill UniversityUnknown
-
Imperial College LondonCompletedColorectal CancerUnited Kingdom
-
Heart and Diabetes Center North-Rhine WestfaliaActive, not recruiting
-
University Hospital, LilleCompleted
-
University Hospital Southampton NHS Foundation...Sheffield Teaching Hospitals NHS Foundation Trust; University Hospitals, Leicester and other collaboratorsCompletedUpper Gastrointestinal DisordersUnited Kingdom
-
University of East AngliaCompletedOesophageal CancerUnited Kingdom
-
Fundación para la Investigación del Hospital Clínico...Recruiting
-
Central Hospital, Nancy, FranceINSERM, UMR-1116; INSERM, CIC 1433Completed
-
Rambam Health Care CampusRecruitingPompe Disease Infantile-OnsetIsrael