Effect of Terlipressin for Intraoperative Blood Pressure Management in Kidney Transplantation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeijing Friendship Hospital
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with end-stage renal disease aged 18 years or above
Disqualifiers
simultaneous multiple organ transplantation
known allergy to study medication
known pregnancy status
cancellation of surgery due to grafts or personal reasons
Trial design
Design model
Parallel
Treatments tested in this trial
terlipressin
DrugPatients 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)
DrugParticipants 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.
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: Placebo (normal saline) + DopaminePlacebo comparator 1 intervention
Group B: Terlipressin + DopamineExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 transplantationSecondary outcomes
1
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 surgery2
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 surgery3
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 74
Renal function at 3 months after kidney transplantation
Renal function assessed by serum creatinine concentration and estimated glomerular filtration rate (eGFR) at 3 months after kidney transplantation.
Time frame
3 months after kidney transplantationSponsors and contacts
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Source ClinicalTrials.gov