Effect of Terlipressin for Intraoperative Blood Pressure Management in Kidney Transplantation

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Kidney Transplant; Intraoperative Hypotension; Delayed Graft Function
• Intervention / Treatment: Drug: Placebo (Normal Saline); Drug: terlipressin

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Beijing Friendship Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients with end-stage renal disease aged 18 years or above

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo (normal saline) + Dopamine; 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.	Drug: 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.
Experimental: Terlipressin + Dopamine; 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.	Drug: terlipressin; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Within 7 days after kidney transplantation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-reperfusion dopamine requirement	Average dopamine infusion rate required to maintain intraoperative hemodynamic targets after graft reperfusion.	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.	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.	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.	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.	3 months and 1 year after kidney transplantation

Collaborators and Investigators

• Sponsor: Beijing Friendship Hospital
• Investigators: Principal Investigator: Fushan Xue, Department of Anesthesiology, Beijing Friendship Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2025
• Primary Completion (Actual): June 15, 2026
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: February 27, 2025
• First Submitted That Met QC Criteria: February 27, 2025
• First Posted (Actual): March 4, 2025

Study Record Updates

• Last Update Posted (Actual): July 13, 2026
• Last Update Submitted That Met QC Criteria: July 9, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Delayed Graft Function; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptide Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Pharmaceutical Preparations; Crystalloid Solutions; Isotonic Solutions; Solutions; Pituitary Hormones, Posterior; Pituitary Hormones; Vasopressins; Lypressin; Terlipressin; Saline Solution
• Other Study ID Numbers: 2025-P2-023-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Selected statistics related to outcomes
• IPD Sharing Time Frame: after published
• IPD Sharing Access Criteria: Investigators who submitting research proposals and signing agreements of data using with corresponding authors
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No