The Predictors for Continuous Renal Replacement Therapy in Liver Transplant Patient

February 26, 2013 updated by: Yonsei University

Background. Acute renal failure after liver transplantation (LT) requiring continuous renal replacement therapy (CRRT) adversely affects patient survival. However, there are few reports to assess the predictors for postoperative CRRT in liver transplant patients. The investigators undertook this study to identify perioperative factors that would predict patients at risk of CRRT.

Patients and Methods. The investigators retrospectively reviewed the data of 148 liver transplant patients from January 2007 to November 2010 at Severance Hospital, Yonsei University HealthSystem, in Seoul, Korea. The number of patients treated with CRRT was 44 (18 patients from living and 26 from deceased donors) and those without CRRT was 104. Univariate and stepwise logistic multivariate analyses were performed.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
148

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

the data of 148 liver transplant patients from January 2008 to December 2011 at Severance Hospital, Yonsei University HealthSystem, in Seoul, Korea. The number of patients treated with CRRT was 44 (18 patients from living and 26 from deceased donors) and those without CRRT was 104.

Description

Inclusion Criteria:

  • Age 19-65 year
  • Liver transplant patients from January 2008 to December 2011

Exclusion Criteria:

  • Patients treated with CRRT before transplantation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
liver transplantation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
status before operation
Time Frame: 1 day before operation
laboratory data(ex : total bilirubin, albumin, coagulation factors, blood gas analysis(arterial CO2 pressure. Blood urea nitrate/Creatinine, Hemoglobin/Hematocrit.)
1 day before operation
the amount of ascites
Time Frame: intraoperative
intraoperative
the duration of anesthesia and operation
Time Frame: intraoperative
intraoperative
intraoperative hemodynamic instability
Time Frame: intraoperative
intraoperative
intraoperative bleeding
Time Frame: intraoperative
intraoperative
Intraoperative urine output
Time Frame: intraoperative
intraoperative
the types of donation(living or deceased donor)
Time Frame: intraoperative
intraoperative
survival rate
Time Frame: on the postoperative 28th days, 365 days
on the postoperative 28th days, 365 days
postoperative bleeding amount
Time Frame: on the postoperative 28th days, 365 days.
on the postoperative 28th days, 365 days.
postoperative CRRT(continuous renal replacement therapy),
Time Frame: on the postoperative 28th days, 365days
on the postoperative 28th days, 365days
mortality
Time Frame: on the postoperative 28th days, 365 days.
on the postoperative 28th days, 365 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yonsei University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

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Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2011

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2011

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 4, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 21, 2011

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 24, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 27, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 4-2010-0671

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