Liver Transplant; ComplicationsNCT05514743
Response of Cardiovascular Parameters to Physical Therapy Post Liver Transplantation
A study testing 6 minute walk test , Blood pressure monitoring in people with Liver Transplant; Complications, run by General Committee of Teaching Hospitals and Institutes, Egypt at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 40 to 60 years, men only
- Conditions the study is for
- Liver Transplant; Complications
- What is being tested?
- 6 minute walk test , Blood pressure monitoring
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 17 Apr 2019to 1 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Age ranged from 40 to 60
- All patients will be medically stable.
- 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).
Who cannot join
- All patients will be subjected to full clinical history and full clinical examination for exclusion of the following:
- Patients with neurological and neuromuscular disease.
- Total liver transplantation.
- Cardiac disease.
- Alcoholic hepatitis.
- Blind individuals.
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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.
- Conditions
- Liver Transplant; Complications
- Being tested
- 6 minute walk test , Blood pressure monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6 minute walk test , Blood pressure monitoringProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Heart rate | Active comparator | 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. Receives: Procedure: 6 minute walk test , Blood pressure monitoring |
| Blood pressure | Active comparator | 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. Receives: Procedure: 6 minute walk test , Blood pressure monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2022
- Study start17 Apr 2019
- Primary completion30 Mar 2022
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Liver Transplant; ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- General Committee of Teaching Hospitals and Institutes, Egypt
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Omnia Saeed Mahmoud Ahmed, General Committee of Teaching Hospitals and Institutes, Egypt
- Investigators
- Omnia Saeed, PhD, Principal investigator, October University for Modern Sciences and Arts
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05514743
- Sponsor's protocol ID
- HS000107
- Status last verified
- Aug 2022
- First submitted
- 23 Aug 2022
- Last updated
- 24 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 20486907Zaky 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.
PubMed 24797833Wong 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.
PubMed 10464050Kwon 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.
PubMed 28583534
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Response of Cardiovascular Parameters to Physical Therapy Post Liver Transplantation
- ClinicalTrials.gov ID
- NCT05514743
- Acronym / sponsor ID
- HS000107
- Conditions
- Liver Transplant; Complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- General Committee of Teaching Hospitals and Institutes, EgyptOther government
- Study start
- 17 Apr 2019 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 24 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heart rate | Active comparator | Procedure: 6 minute walk test , Blood pressure monitoringHeart 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. |
| Blood pressure | Active comparator | Procedure: 6 minute walk test , Blood pressure monitoringIt 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. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age ranged from 40 to 60
- All patients will be medically stable.
- 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).
Key exclusion criteria (6 listed)
- All patients will be subjected to full clinical history and full clinical examination for exclusion of the following:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 6 minute walk test , Blood pressure monitoringHeart 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. | Procedure or surgery | Blood pressure, Heart rate |
Primary outcome
Heart rate
Time frame: 3 weeks
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.
Blood pressure
Time frame: 3 weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2022.
- Background: PubMed 20486907Watt 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.
- Background: PubMed 24797833Zaky 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.
- Background: PubMed 10464050Wong 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.
- Background: PubMed 28583534Kwon 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.
- Cardiovascular dysfunction and liver transplantation. Korean journal of anesthesiology, 71(2), 85-91.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Omnia Saeed, PhD principal investigator
October University for Modern Sciences and Arts
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 6 minute walk test , Blood pressure monitoring in people with Liver Transplant; Complications, run by General Committee of Teaching Hospitals and Institutes, Egypt at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate (time frame: 3 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05514743, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2022.