NCT05514743

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 17, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2022

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 24, 2022

Completed
Last Updated

August 24, 2022

Status Verified

August 1, 2022

Enrollment Period

3 years

First QC Date

August 23, 2022

Last Update Submit

August 23, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

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.

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.

Procedure: 6 minute walk test , Blood pressure monitoring

Interventions

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.

Blood pressureHeart rate

Eligibility Criteria

Age40 Years - 60 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • Patients with neurological and neuromuscular disease.
  • Total liver transplantation.
  • Cardiac disease.
  • Alcoholic hepatitis.
  • Blind individuals.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

El Sahel Teaching Hospital

Cairo, Egypt

Location

Related Publications (4)

  • 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.

    PMID: 20486907BACKGROUND
  • 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.

    PMID: 24797833BACKGROUND
  • 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.

    PMID: 10464050BACKGROUND
  • 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.

    PMID: 28583534BACKGROUND

Related Links

MeSH Terms

Interventions

Blood Pressure Monitors

Intervention Hierarchy (Ancestors)

SphygmomanometersDiagnostic EquipmentEquipment and Supplies

Study Officials

  • Omnia Saeed, PhD

    October University for Modern Sciences and Arts

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.Omnia Saeed Mahmoud Ahmed

Study Record Dates

First Submitted

August 23, 2022

First Posted

August 24, 2022

Study Start

April 17, 2019

Primary Completion

March 30, 2022

Study Completion

April 1, 2022

Last Updated

August 24, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations