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Potassium levels after liver reperfusion in patients undergoing living donor liver transplantation

Status Approved

First Submitted Date

2020/12/20
Registered Date

2021/01/08
Last Updated Date

2021/09/03

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0005754
Unique Protocol ID	2020-12-087
Public/Brief Title	Potassium levels after liver reperfusion in patients undergoing living donor liver transplantation
Scientific Title	Potassium levels after liver reperfusion in patients undergoing living donor liver transplantation
Acronym
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status	Not applicable

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	SMC2020-12-087
Approval Date	2020-12-22
Institutional Review Board Name	Samsung Medical Center Institutional Review Board
Institutional Review Board Address	81, Irwon-ro, Gangnam-gu, Seoul
Institutional Review Board Telephone	02-3410-2973
Data Monitoring Committee	Yes Samsung medical center, office of research subject protection

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Gaabsoo Kim
Title	Professor
Telephone	+82-2-9933-0360
Affiliation	Samsung Medical Center
Address	81, Irwon-ro, Gangnam-gu, Seoul, Republic of Korea
Contact Person for Public Queries
Name	Jeayoun Kim
Title	Fellow
Telephone	+82-2-3410-0369
Affiliation	Samsung Medical Center
Address	81, Irwon-ro, Gangnam-gu, Seoul, Republic of Korea
Contact Person for Updating Information
Name	Jeayoun Kim
Title	Fellow
Telephone	+82-2-3410-0369
Affiliation	Samsung Medical Center
Address	81, Irwon-ro, Gangnam-gu, Seoul, Republic of Korea

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Completed
Date of First Enrollment	2021-01-04 Actual
Target Number of Participant	33
Primary Completion Date	2021-03-30 , Actual
Study Completion Date	2021-05-01 , Actual
Name of Study	Samsung Medical Center
Recruitment Status	Completed
Date of First Enrollment	2021-01-04 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	Samsung Medical Center
Organization Type	Medical Institute
Project ID

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Samsung Medical Center
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	Abrupt derangements of plasma potassium in recipients occasionally occurs after reperfusion during a orthotropic liver transplantation. Elevated potassium levels and subsequent severe hyperkalemia have been known as a risk factor associated with post-reperfusion syndrome and cardiac arrest after reperfusion. Therefore, vigilant monitoring and proactive management of potassium levels is important in orthotopic liver transplantation. Victor et al. measured plasma potassium levels 15 min after reperfusion during orthotopic liver transplantation and identified the risk factors of hyperkalemia. Also, Laurence et al. assessed changes in potassium levels over 13 predefined time points during 5 minutes after reperfusion in cadeaveric liver transplantation. They reported that the plasma potassium reached its highest level at 80 seconds after reperfusion and the cut-off value of baseline plasma potassium level under 4.45 mmol/L would correctly identify the majority of patiens who do not develop reperfusion hyperkalemia (high specificity of 94%). However, the majority of the study object in previous studies underwent cadeaveric liver transplant. Cadeaveric liver transplanation is known to have higher risk of hyperkalemia compared to the living donor liver transplantation and plasma potassium in living donor is expected to show different trend. Currently, there is no study that continuously measure plasma potassium immediately after reperfusion in living donor liver transplantation. We aimed to describe the pattern of change of potassium levels during the reperfusion perioid of living donor liver transplantation.

Study Summary Information

Lay Summary

Abrupt derangements of plasma potassium in recipients occasionally occurs after reperfusion during a orthotropic liver transplantation. Elevated potassium levels and subsequent severe hyperkalemia have been known as a risk factor associated with post-reperfusion syndrome and cardiac arrest after reperfusion. Therefore, vigilant monitoring and proactive management of potassium levels is important in orthotopic liver transplantation. Victor et al. measured plasma potassium levels 15 min after reperfusion during orthotopic liver transplantation and identified the risk factors of hyperkalemia. Also, Laurence et al. assessed changes in potassium levels over 13 predefined time points during 5 minutes after reperfusion in cadeaveric liver transplantation. They reported that the plasma potassium reached its highest level at 80 seconds after reperfusion and the cut-off value of baseline plasma potassium level under 4.45 mmol/L would correctly identify the majority of patiens who do not develop reperfusion hyperkalemia (high specificity of 94&#37;). However, the majority of the study object in previous studies underwent cadeaveric liver transplant. Cadeaveric liver transplanation is known to have higher risk of hyperkalemia compared to the living donor liver transplantation and plasma potassium in living donor is expected to show different trend. Currently, there is no study that continuously measure plasma potassium immediately after reperfusion in living donor liver transplantation. We aimed to describe the pattern of change of potassium levels during the reperfusion perioid of living donor liver transplantation.

8. Study Design

Study Design Information - Study Type, Observational Study Model, Time Perspective, Target Number of Participant, Cohort/Group Number, Cohort/Group, Cohort/Group Label, Cohort/Group Description, Biospecimen Collection & Archiving, Biospecimen Description
Study Type	Observational Study
Observational Study Model	Cohort
Time Perspective	Prospective
Target Number of Participant	33
Cohort/Group Number	1
Cohort/ Group 1	Cohort/Group Label single group (adult recipient who undergo living donor liver transplantation)
Cohort/ Group 1	Cohort/Group Description plasma potassium concentration before and after the reperfusion. vital sign and other blood laboratory test result
Biospecimen Collection & Archiving	Not collect nor Archive
Biospecimen Description

9. Subject Eligibility

Subject Eligibility Information
Study Population Description	adult recipient who undergo living donor liver transplantation
Sampling Method	simple random sampling
Condition(s)/Problem(s)	* (K00-K93)Diseases of the digestive system (K76.9)Liver disease, unspecified liver transplantation
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 19Year~74Year
	Description adult recipient who undergo living donor liver transplantation at Samsung Medical Center
Exclusion Criteria	(1) pediatric patient under 19 (2) geriatric patient age 75 years old or older (3) a recipient who undergo multiorgan transplantation (4) patient who doesn't agree the consent form of the study
Healthy Volunteers	No

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	Not applicable
Outcome	the pattern of change of potassium levels after liver reperfusion during living donor liver transplantation
Timepoint	plasma potassium level measurement immediately prior to repferusion and every 1minute after reperfusion for a duration of 5 minutes
Secondary Outcome(s) 1
Outcome	the time points when plasma potassium peaks after repferusion
Timepoint	after reperfusion for a duration of 5 minutes
Secondary Outcome(s) 2
Outcome	the proportion of patients who developed hyperkalemia after reperfusion
Timepoint	after reperfusion for a duration of 5 minutes
Secondary Outcome(s) 3
Outcome	correlation between changes in potassium levels during reperfusion and perioperative variables
Timepoint	plasma potassium level measurement immediately prior to repferusion and every 1minute after reperfusion for a duration of 5 minutes

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	No

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