An interventional study of terlipressin and Placebo (Normal Saline) in Kidney Transplant, Delayed Graft Function and Intraoperative Hypotension, sponsored by Beijing Friendship Hospital. Active, not recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-13.
Sponsored by Beijing Friendship Hospital · Not applicable, Interventional, and Treatment
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.
83 studies on the registry are indexed under Delayed Graft Function; 15 are open to participants now.
This study's planned enrollment of 150 is above the median of 90 across 62 interventional studies indexed under Delayed Graft Function.
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Exclusion Criteria:
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 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.
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.
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
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.
Time frame: 3 months and 1 year after kidney transplantation
Plan to share: Yes — Selected statistics related to outcomes
Supporting information: Study protocol, Statistical analysis plan
Time frame: after published
Access criteria: Investigators who submitting research proposals and signing agreements of data using with corresponding authors
No publications or documents are linked to this record.
Ran from Mar 2025 to primary completion in Jun 2026, 15 months.
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This study is active, not recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Terlipressin