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NCT Number: NCT06855758

Effect of Terlipressin for Intraoperative Blood Pressure Management in Kidney Transplantation

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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Key information

Conditions

Kidney Transplant Delayed Graft Function Intraoperative Hypotension Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Friendship Hospital

Beijing, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Delayed graft function (DGF)

    Time frame: 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 outcomes

  1. Post-reperfusion dopamine requirement

    Time frame: From graft reperfusion until the end of surgery

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

  2. Area under the curve for MAP below 100 mmHg after graft reperfusion

    Time frame: 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.

  3. Early postoperative renal function (POD7)

    Time frame: Postoperative day 7

    Renal function assessed by serum creatinine concentration and estimated glomerular filtration rate (eGFR) on postoperative day 7 after kidney transplantation.

  4. Serum creatinine after kidney transplantation at 3 months and 1 year

    Time frame: 3 months and 1 year after kidney transplantation

    Serum creatinine concentration measured at 3 months and 1 year after kidney transplantation.

  5. Estimated glomerular filtration rate (eGFR) after kidney transplantation at 3 months and 1 year

    Time frame: 3 months and 1 year after kidney transplantation

    Estimated glomerular filtration rate (eGFR) calculated at 3 months and 1 year after kidney transplantation.

Sponsors and collaborators

Lead sponsor

Beijing Friendship Hospital

Other

Registry information

Official study title

Effect of Terlipressin for Intraoperative Blood Pressure Management in Kidney Transplantation, A Double-blind Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Mar 4, 2025
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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