Effect of Terlipressin for Intraoperative Blood Pressure Management in Kidney Transplantation

N/AActive Not RecruitingNCT06855758

Beijing Friendship Hospital150 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

150

Conditions

Kidney Transplant Delayed Graft Function Intraoperative Hypotension

Interventions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: Within 7 days after kidney transplantation

Secondary Outcomes

Post-reperfusion dopamine requirement

Average dopamine infusion rate required to maintain intraoperative hemodynamic targets after graft reperfusion.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.