Delayed Graft Function, Intraoperative Hypotension, Kidney Transplant
Conditions
Brief summary
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.
Interventions
DRUGterlipressin
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.
DRUGPlacebo (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.
Sponsors
Beijing Friendship Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Delayed graft function (DGF) | Within 7 days after kidney transplantation | Delayed graft function (DGF) was defined as the need for any dialysis treatment within the first 7 days after kidney transplantation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-reperfusion dopamine requirement | From graft reperfusion until the end of surgery | Average dopamine infusion rate required to maintain intraoperative hemodynamic targets after graft reperfusion. |
| Area under the curve for MAP below 100 mmHg after graft reperfusion | From graft reperfusion until the end of surgery | Area under the curve (AUC) for mean arterial pressure (MAP) values below 100 mmHg during the intraoperative period after graft reperfusion. |
| Early postoperative renal function (POD7) | Postoperative day 7 | Renal function assessed by serum creatinine concentration and estimated glomerular filtration rate (eGFR) on postoperative day 7 after kidney transplantation. |
| Serum creatinine after kidney transplantation at 3 months and 1 year | 3 months and 1 year after kidney transplantation | Serum creatinine concentration measured at 3 months and 1 year after kidney transplantation. |
| Estimated glomerular filtration rate (eGFR) after kidney transplantation at 3 months and 1 year | 3 months and 1 year after kidney transplantation | Estimated glomerular filtration rate (eGFR) calculated at 3 months and 1 year after kidney transplantation. |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORFushan Xue
Department of Anesthesiology, Beijing Friendship Hospital
Outcome results
None listed