Response of Cardiovascular Parameters to Physical Therapy Post Liver Transplantation

Liver transplantation (LT) is the only life-saving treatment option in patients with advanced liver disease. Deceased-donor LT is not frequent but is increasing in Asian countries. Because current liver allocation policies follow the severity principle wherein patients at highest risk for mortality receive top priority, anesthesiologists may face severely ill patients more frequently with deceased-donor LT than with living-donor LT. In this regard, with the outstanding surgical success of recent LT, cardiovascular complications have emerged as the leading cause of death after LT, particularly among those with advanced liver cirrhosis

Study Overview

• Status: Completed
• Conditions: Liver Transplant; Complications
• Intervention / Treatment: Procedure: 6 minute walk test , Blood pressure monitoring

Detailed Description

Cardiovascular complications have emerged as the leading cause of death after liver transplantation, particularly among those with advanced liver cirrhosis. Therefore, a thorough and accurate cardiovascular evaluation with clear comprehension of cirrhotic cardiomyopathy is recommended for optimal anesthetic management. However, cirrhotic patients manifest cardiac dysfunction concomitant with pronounced systemic hemodynamic changes, characterized by hyperdynamic circulation such as increased cardiac output, high heart rate, and decreased systemic vascular resistance. These unique features mask significant manifestations of cardiac dysfunction at rest, which makes it difficult to accurately evaluate cardiovascular status As cardiovascular complications are leading causes of nongraft related mortality after LT [2], the importance of identifying masked intrinsic cardiac dysfunction or decreased capacity of cardiac contractility due to external stress has been emphasized. However, detecting ventricular dysfunction in a resting state is difficult, as marked vasodilation and increased arterial compliance lead to latent or mild cardiac manifestations [4]. Different stress tests, using drugs or exercise, have been applied to unmask cardiac dysfunction; however, achieving a target HR and blood pressure is difficult given the poor functional conditions of patients with LC [5].

Dobutamine stress echocardiography (DSE) is recommended to discriminate high-risk patients with ischemic heart disease; however, the accuracy of DSE varies widely among studies as a result of various selection criteria [3] and the inability to achieve the predicted target HR to provoke wall motion abnormalities. This inadequacy is based on the failure of beta receptors to respond to sympathetic stimulation in patients with LC or the use of beta blockers to prevent variceal bleeding. Therefore, the accuracy of DSE is questionable, and its sensitivity is reported as low as 13-14% [6-7]. Nicolau-Raducu et al. [8] demonstrated that DSE has 9% sensitivity, 33% positive predictive value, and 89% negative predictive value for predicting early cardiac events after LT.

The autonomic nervous system is an important regulator of cardiovascular homeostasis, and an HR analysis is considered a surrogate of vagal and sympathetic disturbances. Therefore, HR measurements have been recognized as a prognostic factor in many clinical investigations [9-12]. Studies showing reduced HR variability, which correlates with disease severity, central hypovolemia, and the degree of portal hypertension have also been reported [13-14]. Kim et al. [15] found that sympathetic withdrawal is associated with hypotension after graft reperfusion during LT.

Patients with LC have an increased resting HR due to hyperdynamic circulation, increased circulating catecholamines, and cirrhotic cardiomyopathy [16-17]. Kwon et al. [18] demonstrated that resting HR is associated with all-cause mortality in LT recipients and showed that patients with HR >80 beats/min are significantly associated with a higher risk for all-cause mortality (hazard ratio 1.83) compared to patients with HR ≤65 beats/min.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • El Sahel Teaching hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

1. Age ranged from 40 to 60
2. All patients will be medically stable.
3. All patients will have the same medical care (fluid and electrolyte management in the ICU, immunosuppressive, prophylactic) the patient might also require (antihypertensive medications, insulin or oral hypoglycemic agents, mild analgesics).

Exclusion Criteria:

• All patients will be subjected to full clinical history and full clinical examination for exclusion of the following:

  1. Patients with neurological and neuromuscular disease.
  2. Total liver transplantation.
  3. Cardiac disease.
  4. Alcoholic hepatitis.
  5. Blind individuals.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Heart rate; Heart rate monitors can assess a person's heart rate and reveal whether it is high or low. Heart rate Trusted Source is a "clinical indicator of overall cardiac health," and it can also help a person determine their performance during a workout.	Procedure: 6 minute walk test , Blood pressure monitoring; Heart rate monitors can assess a person's heart rate and reveal whether it is high or low. Heart rate Trusted Source is a "clinical indicator of overall cardiac health," and it can also help a person determine their performance during a workout. Six minute walk test: It will be carried out before and after interventions to determine the patients functional capacity (in the 7th.day &in the 21st.day.) It will be used as a training tool as well as an assessment tool. They will receive conventional physical therapy program which includes deep breathing exercise in form of (diaphragmatic, apical and costal breathing), Training about right way of cough and early ambulation from bed for 3 sessions / week, twice daily for 21 days.
ACTIVE_COMPARATOR: Blood pressure; It will be carried out before and after interventions to determine the patients functional capacity (in the 7th.day &in the 21st.day.) It will be used as a training tool as well as an assessment tool.	Procedure: 6 minute walk test , Blood pressure monitoring; Heart rate monitors can assess a person's heart rate and reveal whether it is high or low. Heart rate Trusted Source is a "clinical indicator of overall cardiac health," and it can also help a person determine their performance during a workout. Six minute walk test: It will be carried out before and after interventions to determine the patients functional capacity (in the 7th.day &in the 21st.day.) It will be used as a training tool as well as an assessment tool. They will receive conventional physical therapy program which includes deep breathing exercise in form of (diaphragmatic, apical and costal breathing), Training about right way of cough and early ambulation from bed for 3 sessions / week, twice daily for 21 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate	Heart rate monitors can assess a person's heart rate and reveal whether it is high or low. Heart rate Trusted Source is a "clinical indicator of overall cardiac health," and it can also help a person determine their performance during a workout. Six minute walk test: It will be carried out before and after interventions to determine the patients functional capacity (in the 7th.day &in the 21st.day.) It will be used as a training tool as well as an assessment tool.	3 weeks
Blood pressure	It will be carried out before and after interventions to determine the patients functional capacity (in the 7th.day &in the 21st.day.) It will be used as a training tool as well as an assessment tool.	3 weeks

Collaborators and Investigators

• Sponsor: General Committee of Teaching Hospitals and Institutes, Egypt
• Investigators: Principal Investigator: Omnia Saeed, PhD, October University for Modern Sciences and Arts

Publications and helpful links

General Publications

• Watt KD, Pedersen RA, Kremers WK, Heimbach JK, Charlton MR. Evolution of causes and risk factors for mortality post-liver transplant: results of the NIDDK long-term follow-up study. Am J Transplant. 2010 Jun;10(6):1420-7. doi: 10.1111/j.1600-6143.2010.03126.x. Epub 2010 May 10.
• Zaky A, Bendjelid K. Appraising cardiac dysfunction in liver transplantation: an ongoing challenge. Liver Int. 2015 Jan;35(1):12-29. doi: 10.1111/liv.12582. Epub 2014 Jun 5.
• Wong F, Liu P, Lilly L, Bomzon A, Blendis L. Role of cardiac structural and functional abnormalities in the pathogenesis of hyperdynamic circulation and renal sodium retention in cirrhosis. Clin Sci (Lond). 1999 Sep;97(3):259-67.
• Kwon HM, Jun IG, Jung KW, Moon YJ, Shin WJ, Song JG, Hwang GS. Pretransplant Resting Heart Rate and Its Association With All-Cause Mortality in Liver Transplant Recipients. Transplant Proc. 2017 Jun;49(5):1092-1096. doi: 10.1016/j.transproceed.2017.03.043.

Helpful Links

• Cardiovascular dysfunction and liver transplantation. Korean journal of anesthesiology, 71(2), 85-91.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 17, 2019
• Primary Completion (ACTUAL): March 30, 2022
• Study Completion (ACTUAL): April 1, 2022

Study Registration Dates

• First Submitted: August 23, 2022
• First Submitted That Met QC Criteria: August 23, 2022
• First Posted (ACTUAL): August 24, 2022

Study Record Updates

• Last Update Posted (ACTUAL): August 24, 2022
• Last Update Submitted That Met QC Criteria: August 23, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: HS000107

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No