Cardiopulmonary Exercise Testing in Cirrhotic Patients: a Pilot Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kymberly D. Watt, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01658982
First received: August 3, 2012
Last updated: November 27, 2013
Last verified: November 2013
  Purpose

Optimizing patient survival and organ utility is a constant struggle for the liver transplant community. Despite rigorous cardiovascular evaluation before liver transplantation cardiovascular events are one of the leading causes of post-transplant morbidity and mortality in both early and late post transplant periods. Poor performance on measures of cardiopulmonary fitness has been associated with worse outcomes in liver transplant candidates. The investigators seek to determine the feasibility of obtaining measures of cardiopulmonary performance in liver transplant candidates from standard cardiopulmonary exercise testing (CPET) and from a modified 3 minute step test and to determine whether the 3 minute step test is suitable for the assessment of cardiopulmonary fitness in a future outcome study.


Condition Intervention
End Stage Liver Disease
Other: cardiopulmonary exercise testing

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cardiopulmonary Exercise Testing in Cirrhotic Patients: a Pilot Study

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • respiratory exchange ratio [ Time Frame: during test ] [ Designated as safety issue: No ]

Enrollment: 6
Study Start Date: August 2012
Study Completion Date: July 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
cirrhotic patients
cardiopulmonary exercise testing
Other: cardiopulmonary exercise testing
3 minute step test compared to 6 minute bicycle test

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

pre liver transpalnt patietns with cirrhosis and end stage liver disease

Criteria

Inclusion Criteria:

  • listed for liver transplantation with end stage liver disease

Exclusion Criteria:

  • patients listed for liver transplant without end stage liver disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01658982

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Kymberly Watt, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Kymberly D. Watt, Assocaite Professor of Medicine, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01658982     History of Changes
Other Study ID Numbers: 12-004215
Study First Received: August 3, 2012
Last Updated: November 27, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Liver Diseases
End Stage Liver Disease
Digestive System Diseases
Liver Failure
Hepatic Insufficiency

ClinicalTrials.gov processed this record on September 22, 2014