Kidney TransplantNCT06855758
Effect of Terlipressin for Intraoperative Blood Pressure Management in Kidney Transplantation
A study testing terlipressin in people with Kidney Transplant and Delayed Graft Function, run by Beijing Friendship Hospital at 1 site in China.
Trial summary
Prospective double blind randomized controlled trial. By randomizing patients undergoing kidney transplantation into a conventional catecholamine drug (dobutamine) blood pressure maintenance group and a terlipressin-complexed dobutamine group, the investigators compared the effect of intraoperative blood pressure… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant, Delayed Graft Function, Intraoperative Hypotension
- What is being tested?
- terlipressin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 6 Mar 2025to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with end-stage renal disease aged 18 years or above
Who cannot join
- simultaneous multiple organ transplantation
- known allergy to study medication
- known pregnancy status
- cancellation of surgery due to grafts or personal reasons
- persistent severe preoperative hypertension that may not require intraoperative supportive therapy with vasoactive medications
- any other reason that the supervising physician or the anesthesiologist on duty think the patient is not suitable for the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Terlipressin for Intraoperative Blood Pressure Management in Kidney Transplantation, A Double-blind Randomized Controlled Trial
Prospective double blind randomized controlled trial. By randomizing patients undergoing kidney transplantation into a conventional catecholamine drug (dobutamine) blood pressure maintenance group and a terlipressin-complexed dobutamine group, the investigators compared the effect of intraoperative blood pressure maintenance and the dosage of the vasoactive drug, postoperative graft function, delayed graft function, and other related complications between the two groups, in order to demonstrate whether the use of terlipressin for blood pressure regulation during kidney transplantation is superior to the existing treatments.
- Being tested
- terlipressin, Placebo (Normal Saline)
- Medical subject headings
- Delayed Graft Function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
terlipressinDrug
Patients randomized to the intervention group received terlipressin during renal artery anastomosis to achieve a target mean arterial pressure (MAP) of at least 100 mmHg before graft reperfusion. Terlipressin was prepared as 1 mg diluted to 10 mL and administered via syringe pump at 60 mL/h (approximately 10 minutes for full administration). Administration was initiated when MAP was below the target level (<100 mmHg) before graft reperfusion and could be discontinued when MAP was considered adequately above the target level according to the investigator's clinical judgment.
Placebo (Normal Saline)Drug
Participants assigned to the control group received an equivalent volume of normal saline administered via syringe pump during renal artery anastomosis using the same procedure and infusion rate as the intervention group to maintain blinding.
| Study group | Role | What they receive |
|---|---|---|
| Placebo (normal saline) + Dopamine | Placebo comparator | Participants assigned to the placebo comparator group received protocol-directed hemodynamic management with a target mean arterial pressure (MAP) of at least 100 mmHg before graft reperfusion. Dopamine infusion was titrated according to intraoperative hemodynamic requirements and could be reduced or discontinued when clinically appropriate. During renal artery anastomosis, placebo (normal saline) was administered using the same preparation, administration procedure, and infusion rate as in the intervention group to maintain blinding. Receives: Drug: Placebo (Normal Saline) |
| Terlipressin + Dopamine | Experimental | Participants assigned to the intervention group received protocol-directed hemodynamic management with a target mean arterial pressure (MAP) of at least 100 mmHg before graft reperfusion. Dopamine infusion was titrated according to intraoperative hemodynamic requirements and could be reduced or discontinued when clinically appropriate. During renal artery anastomosis, terlipressin was administered in addition to standard hemodynamic management. Receives: Drug: terlipressin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delayed graft function (DGF)
Delayed graft function (DGF) was defined as the need for any dialysis treatment within the first 7 days after kidney transplantation.
Measured: Within 7 days after kidney transplantation
Secondary outcomes (5)
Post-reperfusion dopamine requirement
Average dopamine infusion rate required to maintain intraoperative hemodynamic targets after graft reperfusion.
Measured: From graft reperfusion until the end of surgery
Area under the curve for MAP below 100 mmHg after graft reperfusion
Area under the curve (AUC) for mean arterial pressure (MAP) values below 100 mmHg during the intraoperative period after graft reperfusion.
Measured: From graft reperfusion until the end of surgery
Early postoperative renal function (POD7)
Renal function assessed by serum creatinine concentration and estimated glomerular filtration rate (eGFR) on postoperative day 7 after kidney transplantation.
Measured: Postoperative day 7
Serum creatinine after kidney transplantation at 3 months and 1 year
Serum creatinine concentration measured at 3 months and 1 year after kidney transplantation.
Measured: 3 months and 1 year after kidney transplantation
Estimated glomerular filtration rate (eGFR) after kidney transplantation at 3 months and 1 year
Estimated glomerular filtration rate (eGFR) calculated at 3 months and 1 year after kidney transplantation.
Measured: 3 months and 1 year after kidney transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start6 Mar 2025
- Primary completion15 Jun 2026
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantStudies of the same condition, open and under way.
- More trials run by Beijing Friendship 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fushan Xue, Principal investigator, Department of Anesthesiology, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06855758
- Sponsor's protocol ID
- 2025-P2-023-01
- Status last verified
- Feb 2026
- First submitted
- 27 Feb 2025
- Last updated
- 13 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Selected statistics related to outcomes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Terlipressin for Intraoperative Blood Pressure Management in Kidney Transplantation, A Double-blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06855758
- Acronym / sponsor ID
- 2025-P2-023-01
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Study start
- 6 Mar 2025 (actual)
- Primary completion
- 15 Jun 2026 (actual)
- Study completion
- Jun 2027 (estimated)
- First posted
- 4 Mar 2025 (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.
Prospective double blind randomized controlled trial. By randomizing patients undergoing kidney transplantation into a conventional catecholamine drug (dobutamine) blood pressure maintenance group and a terlipressin-complexed dobutamine group, the investigators compared the effect of intraoperative blood pressure maintenance and the dosage of the vasoactive drug, postoperative graft function, delayed graft function, and other related complications between the two groups, in order to demonstrate whether the use of terlipressin for blood pressure regulation during kidney transplantation is superior to the existing treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo (normal saline) + Dopamine | Placebo comparator | Drug: Placebo (Normal Saline)Participants assigned to the placebo comparator group received protocol-directed hemodynamic management with a target mean arterial pressure (MAP) of at least 100 mmHg before graft reperfusion. Dopamine infusion was titrated according to intraoperative hemodynamic requirements and could be reduced or discontinued when clinically appropriate. During renal artery anastomosis, placebo (normal saline) was administered using the same preparation, administration procedure, and infusion rate as in the intervention group to maintain blinding. |
| Terlipressin + Dopamine | Experimental | Drug: terlipressinParticipants assigned to the intervention group received protocol-directed hemodynamic management with a target mean arterial pressure (MAP) of at least 100 mmHg before graft reperfusion. Dopamine infusion was titrated according to intraoperative hemodynamic requirements and could be reduced or discontinued when clinically appropriate. During renal artery anastomosis, terlipressin was administered in addition to standard hemodynamic management. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with end-stage renal disease aged 18 years or above
Key exclusion criteria (6 listed)
- simultaneous multiple organ transplantation
- known allergy to study medication
- known pregnancy status
- cancellation of surgery due to grafts or personal reasons
- persistent severe preoperative hypertension that may not require intraoperative supportive therapy with vasoactive medications
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 |
|---|---|---|
| terlipressinPatients randomized to the intervention group received terlipressin during renal artery anastomosis to achieve a target mean arterial pressure (MAP) of at least 100 mmHg before graft reperfusion. Terlipressin was prepared as 1 mg diluted to 10 mL and administered via syringe pump at 60 mL/h (approximately 10 minutes for full administration). Administration was initiated when MAP was below the target level (<100 mmHg) before graft reperfusion and could be discontinued when MAP was considered adequately above the target level according to the investigator's clinical judgment. | Drug | Terlipressin + Dopamine |
| Placebo (Normal Saline)Participants assigned to the control group received an equivalent volume of normal saline administered via syringe pump during renal artery anastomosis using the same procedure and infusion rate as the intervention group to maintain blinding. | Drug | Placebo (normal saline) + Dopamine |
Primary outcome
Delayed graft function (DGF)
Time frame: Within 7 days after kidney transplantation
Delayed graft function (DGF) was defined as the need for any dialysis treatment within the first 7 days after kidney transplantation.
5 secondary outcomes
Post-reperfusion dopamine requirement
Time frame: From graft reperfusion until the end of surgery
Area under the curve for MAP below 100 mmHg after graft reperfusion
Time frame: From graft reperfusion until the end of surgery
Early postoperative renal function (POD7)
Time frame: Postoperative day 7
Serum creatinine after kidney transplantation at 3 months and 1 year
Time frame: 3 months and 1 year after kidney transplantation
Estimated glomerular filtration rate (eGFR) after kidney transplantation at 3 months and 1 year
Time frame: 3 months and 1 year after kidney transplantation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: Yes. Selected statistics related to outcomes
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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.
Fushan Xue principal investigator
Department of Anesthesiology, Beijing Friendship Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing terlipressin in people with Kidney Transplant and Delayed Graft Function, run by Beijing Friendship 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 1 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 13 Jul 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Delayed graft function (DGF) (time frame: Within 7 days after kidney transplantation). 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 Jul 2026.