Effect of Terlipressin for Intraoperative Blood Pressure Management in Kidney Transplantation

NCT ID: NCT06855758

Last Updated: 2025-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-06

Study Completion Date

2027-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Kidney Transplant Delayed Graft Function Intraoperative Hypotension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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dopamine

Continuous using of dopamine as blood pressure regulation after anesthesia, with dosage adjusted according to intraoperative needs

Group Type NO_INTERVENTION

No interventions assigned to this group

terlipressin + dopamine

Terlipressin was given before the graft circulation was established while continuous using of dopamine during the whole operation

Group Type EXPERIMENTAL

terlipressin

Intervention Type DRUG

Terlipressin was given prior to the opening of the graft circulation (with the possibility of reperfusion hypotension) when the blood pressure is suboptimal and does not respond well to dobutamine or fluid volume resuscitation. 1 mg terlipressin + 100 ml of sodium chloride injections was given for intravenous infusion.

Interventions

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terlipressin

Terlipressin was given prior to the opening of the graft circulation (with the possibility of reperfusion hypotension) when the blood pressure is suboptimal and does not respond well to dobutamine or fluid volume resuscitation. 1 mg terlipressin + 100 ml of sodium chloride injections was given for intravenous infusion.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Friendship Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fushan Xue

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology, Beijing Friendship Hospital

Locations

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Beijing Friendship Hospital

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Wenhe Yang

Role: CONTACT

86 13810673664

Other Identifiers

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2025-P2-023-01

Identifier Type: -

Identifier Source: org_study_id

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