End Stage Liver DIseaseNCT05386953
Intraoperative Normal Saline Administration and Acute Kidney Injury in Patients Undergoing Liver Transplantation
An observational study of End Stage Liver DIsease and Liver Transplant; Complications, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The investigators attempted to investigate the association of the type of crystalloid administered during liver transplantation with postoperative clinical outcomes. The investigators hypothesized that the greater amount of normal saline or half-saline administered during liver transplantation might be associated with… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- End Stage Liver DIsease, Liver Transplant; Complications, Liver Cirrhosis
- What is being tested?
- Normal saline and Balanced crystalloid solution
- How many people
- 1,440 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Apr 2022to 31 Dec 2022
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients received liver transplantation surgery in a single tertiary care university hospital
Who may be able to join
- Consecutive patients who underwent living or deceased donor liver transplantation at our tertiary care university hospital between 2004 and 2018
Who cannot join
- patients with baseline renal dysfunction of hepatorenal syndrome or chronic kidney disease
- missing preoperative serum creatinine value
- missing other baseline or outcome variables
- patients who received retransplantation
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 03080
Won Ho Kim, MD,PhD, 82-2-2072-3484 ext. 3484, wonhokim.ane@gmail.com
Ji-Yoon Jung, MD, 82-2-2072-2462 ext. 2462, jiyooning1030@gmail.com
About this study
Official title: Intraoperative Normal Saline Administration and Acute Kidney Injury in Patients Undergoing Liver Transplantation: a Retrospective Cohort Study
The investigators attempted to investigate the association of the type of crystalloid administered during liver transplantation with postoperative clinical outcomes. The investigators hypothesized that the greater amount of normal saline or half-saline administered during liver transplantation might be associated with the increased risk of acute kidney injury compared to the balanced crystalloids.
Read the detailed description
Liver transplantation requires a long operation time and is often associated with a significant amount of surgical bleeding. It is common for the anesthesiologist to infuse large amounts of fluid or blood products due to bleeding, hemodynamic instability, or ascites drainage. Therefore, in the anesthesia for liver transplantation, optimal management of fluid administration is necessary and the choice of the type of crystalloid may affect the prognosis or the incidence of postoperative complications of patients.
The investigators attempted to investigate the association of the type of crystalloid administered during liver transplantation with postoperative clinical outcomes. The investigators hypothesized that the greater amount of normal saline or half-saline administered during liver transplantation might be associated with the increased risk of acute kidney injury compared to the balanced crystalloids.
- Being tested
- Normal saline, Balanced crystalloid solution
- Medical subject headings
- End Stage Liver Disease, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal salineDrug
Patients received normal saline as a maintenance crystalloid during liver transplantation surgery.
Balanced crystalloid solutionDrug
Also called Lactated Ringer's solution, Plasma solution
Patients received balanced crystalloids such as lactated Ringer's solution or Plasma solution as a maintenance crystalloid during liver transplantation surgery.
| Study group | Role | What they receive |
|---|---|---|
| Balanced group | Patients who received balanced crystalloids of lactated Ringer's solution or plasma solution during liver transplantation surgery Receives: Drug: Balanced crystalloid solution | |
| Saline group | Patients who received only normal saline during liver transplantation surgery Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute kidney injury
The investigators defined acute kidney injury by the KDIGO (Kidney Disease Improving Global Outcomes) criteria, which was determined according to the greatest change in serum creatinine level during the postoperative seven days (Stage 1: more than 1.5-fold; stage 2: more than 2-fold; stage 3: more than 3-fold increase of baseline or increase in SCr to ≥ 4.0 mg/dL or the initiation of renal replacement therapy). The most recent SCr level measured before surgery was collected as a baseline value.
Measured: the first 7 postoperative days
Secondary outcomes (6)
Incidence of postoperative hemodialysis
the incidence of new-onset postoperative hemodialysis during hospitalization
Measured: the first month after admission
Early allograft dysfunction
One or more of the following are present within the first 7 postoperative days: total bilirubin ≥ 10 mg/dL, PT (prothrombin time):INR (international normalized ratio)≥ 1.6, or AST (aspartate aminotransferase)/ALT (alanine aminotransferase) > 2000 IU/L
Measured: the first 7 postoperative days
In-hospital mortality
all-cause mortality during hospitalization
Measured: the first month after admission
One-year mortality
all-cause mortality during one year after transplantation
Measured: one year after transplantation
Length of intensive care unit stay
Length of intensive care unit stay after transplantation
Measured: the first month after admission
Length of hospital stay
Length of hospital stay after transplantation
Measured: the first month after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study start1 Apr 2022
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Liver DIseaseStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Won Ho Kim, MD, Seoul National University Hospital
- Investigators
- Won Ho Kim, MD, PhD, Study chair, Department of Anaesthesiology and Pain Medicine, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05386953
- Sponsor's protocol ID
- H-2108-173-1248
- Status last verified
- May 2022
- First submitted
- 15 May 2022
- Last updated
- 27 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Normal Saline Administration and Acute Kidney Injury in Patients Undergoing Liver Transplantation: a Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT05386953
- Acronym / sponsor ID
- H-2108-173-1248
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,440 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 24 May 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.
The investigators attempted to investigate the association of the type of crystalloid administered during liver transplantation with postoperative clinical outcomes. The investigators hypothesized that the greater amount of normal saline or half-saline administered during liver transplantation might be associated with the increased risk of acute kidney injury compared to the balanced crystalloids.
Detailed description
Liver transplantation requires a long operation time and is often associated with a significant amount of surgical bleeding. It is common for the anesthesiologist to infuse large amounts of fluid or blood products due to bleeding, hemodynamic instability, or ascites drainage. Therefore, in the anesthesia for liver transplantation, optimal management of fluid administration is necessary and the choice of the type of crystalloid may affect the prognosis or the incidence of postoperative complications of patients.
The investigators attempted to investigate the association of the type of crystalloid administered during liver transplantation with postoperative clinical outcomes. The investigators hypothesized that the greater amount of normal saline or half-saline administered during liver transplantation might be associated with the increased risk of acute kidney injury compared to the balanced crystalloids.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Balanced group | – | Drug: Balanced crystalloid solutionPatients who received balanced crystalloids of lactated Ringer's solution or plasma solution during liver transplantation surgery |
| Saline group | – | Drug: Normal salinePatients who received only normal saline during liver transplantation surgery |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients received liver transplantation surgery in a single tertiary care university hospital
Key inclusion criteria (1 listed)
- Consecutive patients who underwent living or deceased donor liver transplantation at our tertiary care university hospital between 2004 and 2018
Key exclusion criteria (4 listed)
- patients with baseline renal dysfunction of hepatorenal syndrome or chronic kidney disease
- missing preoperative serum creatinine value
- missing other baseline or outcome variables
- patients who received retransplantation
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 |
|---|---|---|
| Normal salinePatients received normal saline as a maintenance crystalloid during liver transplantation surgery. | Drug | Saline group |
| Balanced crystalloid solutionAlso: Lactated Ringer's solution, Plasma solutionPatients received balanced crystalloids such as lactated Ringer's solution or Plasma solution as a maintenance crystalloid during liver transplantation surgery. | Drug | Balanced group |
Primary outcome
Acute kidney injury
Time frame: the first 7 postoperative days
The investigators defined acute kidney injury by the KDIGO (Kidney Disease Improving Global Outcomes) criteria, which was determined according to the greatest change in serum creatinine level during the postoperative seven days (Stage 1: more than 1.5-fold; stage 2: more than 2-fold; stage 3: more than 3-fold increase of baseline or increase in SCr to ≥ 4.0 mg/dL or the initiation of renal replacement therapy). The most recent SCr level measured before surgery was collected as a baseline value.
6 secondary outcomes
Incidence of postoperative hemodialysis
Time frame: the first month after admission
Early allograft dysfunction
Time frame: the first 7 postoperative days
In-hospital mortality
Time frame: the first month after admission
One-year mortality
Time frame: one year after transplantation
Length of intensive care unit stay
Time frame: the first month after admission
Length of hospital stay
Time frame: the first month after admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2022.
- Individual participant dataSharing planned: No
Related trials for End Stage Liver DIsease
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
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Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruiting
LiverPAL: A Trial of Inpatient Palliative Care for Patients With Advanced Liver Disease
Liver Disease Chronic, End Stage Liver DIsease
RecruitingObservational study
Establishing a Reference Framework for Outcomes After Machine-Preserved Liver Transplantation in Europe
End-stage Liver Disease (ESLD), Acute Liver Failure
RecruitingObservational study
CytOSorb TreatMent Of Critically Ill PatientS Registry
Septic Shock, Acute Respiratory Distress Syndrome
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.
Won Ho Kim, MD, PhD study chair
Department of Anaesthesiology and Pain Medicine, Seoul National University Hospital
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 End Stage Liver DIsease and Liver Transplant; Complications, run by Seoul National University Hospital 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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 27 May 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ji-yoon Jung, MD (82-2-2072-2469, jiyooning1030@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute kidney injury (time frame: the first 7 postoperative days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 May 2022.