Liver TransplantationNCT01457534
The Predictors for Continuous Renal Replacement Therapy in Liver Transplant Patient
An observational study of Liver Transplantation, run by Yonsei University at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Liver Transplantation
- How many people
- 148 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2011to Feb 2011
- Phase
- Observational
- 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 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Age 19-65 year
- Liver transplant patients from January 2008 to December 2011
Who cannot join
- Patients treated with CRRT before transplantation
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Liver Transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| liver transplantation | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
status before operation
laboratory data(ex : total bilirubin, albumin, coagulation factors, blood gas analysis(arterial CO2 pressure. Blood urea nitrate/Creatinine, Hemoglobin/Hematocrit.)
Measured: 1 day before operation
the amount of ascites
Measured: intraoperative
the duration of anesthesia and operation
Measured: intraoperative
intraoperative hemodynamic instability
Measured: intraoperative
intraoperative bleeding
Measured: intraoperative
Intraoperative urine output
Measured: intraoperative
the types of donation(living or deceased donor)
Measured: intraoperative
survival rate
Measured: on the postoperative 28th days, 365 days
postoperative bleeding amount
Measured: on the postoperative 28th days, 365 days.
postoperative CRRT(continuous renal replacement therapy),
Measured: on the postoperative 28th days, 365days
mortality
Measured: on the postoperative 28th days, 365 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2011 (estimated)
- Study startJan 2011
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01457534
- Sponsor's protocol ID
- 4-2010-0671
- Status last verified
- Feb 2013
- First submitted
- 4 Oct 2011
- Last updated
- 27 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Wong LP, Blackley MP, Andreoni KA, Chin H, Falk RJ, Klemmer PJ. Survival of liver transplant candidates with acute renal failure receiving renal replacement therapy. Kidney Int. 2005 Jul;68(1):362-70. doi: 10.1111/j.1523-1755.2005.00408.x.
PubMed 15954928Wu CC, Yeung LK, Tsai WS, Tseng CF, Chu P, Huang TY, Lin YF, Lu KC. Incidence and factors predictive of acute renal failure in patients with advanced liver cirrhosis. Clin Nephrol. 2006 Jan;65(1):28-33. doi: 10.5414/cnp65028.
PubMed 16429839Gonwa TA, Mai ML, Melton LB, Hays SR, Goldstein RM, Levy MF, Klintmalm GB. Renal replacement therapy and orthotopic liver transplantation: the role of continuous veno-venous hemodialysis. Transplantation. 2001 May 27;71(10):1424-8. doi: 10.1097/00007890-200105270-00012.
PubMed 11391230Holt AW, Bierer P, Bersten AD, Bury LK, Vedig AE. Continuous renal replacement therapy in critically ill patients: monitoring circuit function. Anaesth Intensive Care. 1996 Aug;24(4):423-9. doi: 10.1177/0310057X9602400402.
PubMed 8862637Matsubara S, Okabe K, Ouchi K, Miyazaki Y, Yajima Y, Suzuki H, Otsuki M, Matsuno S. Continuous removal of middle molecules by hemofiltration in patients with acute liver failure. Crit Care Med. 1990 Dec;18(12):1331-8. doi: 10.1097/00003246-199012000-00005.
PubMed 2245605
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Predictors for Continuous Renal Replacement Therapy in Liver Transplant Patient
- ClinicalTrials.gov ID
- NCT01457534
- Acronym / sponsor ID
- 4-2010-0671
- Conditions
- Liver Transplantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 24 Oct 2011 (estimated)
- 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.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| liver transplantation | – | – |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Age 19-65 year
- Liver transplant patients from January 2008 to December 2011
Key exclusion criteria (1 listed)
- Patients treated with CRRT before transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.)
the amount of ascites
Time frame: intraoperative
the duration of anesthesia and operation
Time frame: intraoperative
intraoperative hemodynamic instability
Time frame: intraoperative
intraoperative bleeding
Time frame: intraoperative
Intraoperative urine output
Time frame: intraoperative
the types of donation(living or deceased donor)
Time frame: intraoperative
survival rate
Time frame: on the postoperative 28th days, 365 days
postoperative bleeding amount
Time frame: on the postoperative 28th days, 365 days.
postoperative CRRT(continuous renal replacement therapy),
Time frame: on the postoperative 28th days, 365days
mortality
Time frame: on the postoperative 28th days, 365 days.
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 27 Feb 2013.
- Background: PubMed 15954928Wong LP, Blackley MP, Andreoni KA, Chin H, Falk RJ, Klemmer PJ. Survival of liver transplant candidates with acute renal failure receiving renal replacement therapy. Kidney Int. 2005 Jul;68(1):362-70. doi: 10.1111/j.1523-1755.2005.00408.x.
- Background: PubMed 16429839Wu CC, Yeung LK, Tsai WS, Tseng CF, Chu P, Huang TY, Lin YF, Lu KC. Incidence and factors predictive of acute renal failure in patients with advanced liver cirrhosis. Clin Nephrol. 2006 Jan;65(1):28-33. doi: 10.5414/cnp65028.
- Background: PubMed 11391230Gonwa TA, Mai ML, Melton LB, Hays SR, Goldstein RM, Levy MF, Klintmalm GB. Renal replacement therapy and orthotopic liver transplantation: the role of continuous veno-venous hemodialysis. Transplantation. 2001 May 27;71(10):1424-8. doi: 10.1097/00007890-200105270-00012.
- Background: PubMed 8862637Holt AW, Bierer P, Bersten AD, Bury LK, Vedig AE. Continuous renal replacement therapy in critically ill patients: monitoring circuit function. Anaesth Intensive Care. 1996 Aug;24(4):423-9. doi: 10.1177/0310057X9602400402.
- Background: PubMed 2245605Matsubara S, Okabe K, Ouchi K, Miyazaki Y, Yajima Y, Suzuki H, Otsuki M, Matsuno S. Continuous removal of middle molecules by hemofiltration in patients with acute liver failure. Crit Care Med. 1990 Dec;18(12):1331-8. doi: 10.1097/00003246-199012000-00005.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Transplantation, run by Yonsei University at 1 site in South Korea.
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 2 inclusion and 1 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 27 Feb 2013. 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 South Korea. 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?
status before operation (time frame: 1 day before operation). The study lists 11 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 NCT01457534, which also lists 5 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 27 Feb 2013.