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NCT06855758·Not applicable·INTERVENTIONAL

Effect of Terlipressin for Intraoperative Blood Pressure Management in Kidney Transplantation

VasopressinTerlipressinOtherActive, not recruiting

Status

Active, not recruiting

Phase

Not applicable

Enrollment

150

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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

Treatment arms and agents.

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.

DRUG

Placebo (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.

Timeline

From registration to results.

  1. First posted

    Mar 4, 2025

  2. Study start

    Mar 6, 2025

  3. Primary completion

    Jun 15, 2026

  4. Study completion

    Jun 2027

  5. Results posted

    Not reported

  6. Registry updated

    Jul 13, 2026

Outcomes

What the study measures.

Primary outcomes

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

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.

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.

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.

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.

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.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
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

Study locations

1 registered sites.

China. Showing up to 24 locations stored in the fast local snapshot.

Beijing Friendship Hospital

Beijing, China

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

Related trials

More studies on Vasopressin.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.

TrialsVasopressin trial dashboard →DatabaseVasopressin database entry →ResearchVasopressin research guide →TrialsTerlipressin trial dashboard →DatabaseTerlipressin database entry →ResearchTerlipressin research guide →