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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| terlipressin | Drug | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wenhe Yang | Contact | 86 13810673664 | 13810673664@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Fushan Xue | Department of Anesthesiology, Beijing Friendship Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Friendship Hospital | Recruiting | Beijing | China |
Selected statistics related to outcomes
after published
Investigators who submitting research proposals and signing agreements of data using with corresponding authors
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| ID | Term |
|---|---|
| D051799 | Delayed Graft Function |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077585 | Terlipressin |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D008236 | Lypressin |
| D014667 | Vasopressins |
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
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|
| 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. |
|
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 |
| 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. | 3 months after kidney transplantation |
| D036361 |
| Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |