Response of Cardiovascular Parameters to Physical Therapy Post Liver Transplantation

Liver Transplant; Complications Clinical Trial

Official title:

Response of Cardiovascular Parameters to Physical Therapy Post Liver Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05514743
• Other study ID #: HS000107
• Status: Completed
• Phase: N/A
• Start date: April 17, 2019
• Est. completion date: April 1, 2022

Study information

• Verified date: August 2022
• Source: General Committee of Teaching Hospitals and Institutes, Egypt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 1, 2022
• Est. primary completion date: March 30, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Liver Transplant; Complications

Intervention

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.

Locations

Country	Name	City	State
Egypt	El Sahel Teaching Hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
General Committee of Teaching Hospitals and Institutes, Egypt

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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

External Links

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