Acute Kidney InjuryPhase 4NCT06108362
Effect of Terlipressin on the Incidence of Early Postoperative Acute Kidney Injury in Liver Transplantation Patients
A Phase 4 study testing Terlipressin and normal saline in people with Acute Kidney Injury and Liver Transplant; Complications, run by Beijing Tsinghua Chang Gung Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to evaluate the effect of intraoperative terlipressin on the incidence of early postoperative acute kidney injury in deceased doner liver transplantation. Patients were randomly divided into experimental group and control group by numerical randomization table. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute Kidney Injury, Liver Transplant; Complications
- What is being tested?
- Terlipressin and normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteChina
- Study dates
- 25 Oct 2023to 1 May 2026
- Phase
- Phase 4
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 to 70 years who are scheduled to undergo liver transplantation at our hospital
- Written informed consent provided by the patient or the patient's legally authorized representative
Who cannot join
- Patients undergoing autologous liver transplantation or combined organ transplantation
- Patients with lower-extremity arterial stenosis
- Patients with severe cardiac, pulmonary, or renal disease
- Patients who received renal replacement therapy before surgery
- Patients in whom the depth of either kidney from the body surface is greater than 4 cm
- Patients who received terlipressin within 2 weeks before surgery
- Patients with a known allergy or hypersensitivity to terlipressin
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Tsinghua Chang Gung Hospital
Beijing, Beijing Municipality, 1000000
About this study
Official title: Effect of Intraoperative Terlipressin on the Incidence of Early Postoperative Acute Kidney Injury in Liver Transplantation Patients: a Randomized, Double-blind, Placebo-controlled Study
The goal of this clinical trial is to evaluate the effect of intraoperative terlipressin on the incidence of early postoperative acute kidney injury in deceased doner liver transplantation. Patients were randomly divided into experimental group and control group by numerical randomization table. The experimental group was injected with terlipressin perioperative and the control group was injected with placebo
Read the detailed description
acute kidney injury is a relatively common complication in patients with liver transplantation. Most centers have established prediction models for acute kidney injury after liver transplantation, but the incidence cannot be reduced through perioperative anesthesia management. As an vasopressin receptor agonist, terlipressin can increase blood pressure and improve kidney perfusion at the same time, and perioperative application may reduce the incidence of postoperative acute kidney injury
- Being tested
- Terlipressin, normal saline
- Keywords
- terlipressin, Liver Transplant
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TerlipressinDrug
Also called Glypressin
The medication is dispensed by the nursing staff before surgery and given to the anesthesiologist before the procedure begins
normal salineDrug
Also called normal sodium
The medication is dispensed by the nursing staff before surgery and given to the anesthesiologist before the procedure begins
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Continuous terlipressin infusion，Use a syringe to dilute to 50ml Infusion speed is 2ug/kg*h, From the beginning to the end of the surgery. Receives: Drug: Terlipressin |
| control group | Placebo comparator | Continuous normal saline infusion，Use a syringe to draw 50ml Infusion speed is 4ml/h, From the beginning to the end of the surgery. Receives: Drug: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of acute kidney injury after liver transplantation
acute kidney injury diagnostic criteria (2012 edition)
Measured: in 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start25 Oct 2023
- Primary completion8 Nov 2024
- Study completion1 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Beijing Tsinghua Chang Gung 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tsinghua Chang Gung Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huan Zhang, Doctor, Study chair, department of anesthesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06108362
- Sponsor's protocol ID
- 23344-4-02
- Status last verified
- Oct 2026
- First submitted
- 25 Oct 2023
- Last updated
- 13 Oct 2026
- Results posted
- 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 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intraoperative Terlipressin on the Incidence of Early Postoperative Acute Kidney Injury in Liver Transplantation Patients: a Randomized, Double-blind, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT06108362
- Acronym / sponsor ID
- 23344-4-02
- Keywords
- terlipressin, Liver Transplant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Beijing Tsinghua Chang Gung HospitalUniversity, hospital or other
- Study start
- 25 Oct 2023 (actual)
- Primary completion
- 8 Nov 2024 (actual)
- Study completion
- 1 May 2026 (actual)
- First posted
- 31 Oct 2023 (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 goal of this clinical trial is to evaluate the effect of intraoperative terlipressin on the incidence of early postoperative acute kidney injury in deceased doner liver transplantation. Patients were randomly divided into experimental group and control group by numerical randomization table. The experimental group was injected with terlipressin perioperative and the control group was injected with placebo
Detailed description
acute kidney injury is a relatively common complication in patients with liver transplantation. Most centers have established prediction models for acute kidney injury after liver transplantation, but the incidence cannot be reduced through perioperative anesthesia management. As an vasopressin receptor agonist, terlipressin can increase blood pressure and improve kidney perfusion at the same time, and perioperative application may reduce the incidence of postoperative acute kidney injury
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Drug: TerlipressinContinuous terlipressin infusion，Use a syringe to dilute to 50ml Infusion speed is 2ug/kg*h, From the beginning to the end of the surgery. |
| control group | Placebo comparator | Drug: normal salineContinuous normal saline infusion，Use a syringe to draw 50ml Infusion speed is 4ml/h, From the beginning to the end of the surgery. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged 18 to 70 years who are scheduled to undergo liver transplantation at our hospital
- Written informed consent provided by the patient or the patient's legally authorized representative
Key exclusion criteria (7 listed)
- Patients undergoing autologous liver transplantation or combined organ transplantation
- Patients with lower-extremity arterial stenosis
- Patients with severe cardiac, pulmonary, or renal disease
- Patients who received renal replacement therapy before surgery
- Patients in whom the depth of either kidney from the body surface is greater than 4 cm
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 |
|---|---|---|
| TerlipressinAlso: GlypressinThe medication is dispensed by the nursing staff before surgery and given to the anesthesiologist before the procedure begins | Drug | experimental group |
| normal salineAlso: normal sodiumThe medication is dispensed by the nursing staff before surgery and given to the anesthesiologist before the procedure begins | Drug | control group |
Primary outcome
Incidence of acute kidney injury after liver transplantation
Time frame: in 7 days
acute kidney injury diagnostic criteria (2012 edition)
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 13 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Huan Zhang, Doctor study chair
department of anesthesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Terlipressin and normal saline in people with Acute Kidney Injury and Liver Transplant; Complications, run by Beijing Tsinghua Chang Gung Hospital at 1 site in China.
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 7 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 13 Oct 2026. 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 China. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Incidence of acute kidney injury after liver transplantation (time frame: in 7 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 13 Oct 2026.