NCT03477461

Effects of Terlipressin on Management of Potential Organ Donors

Completed Last updated 26 March 2018

What this trial tests

trial testing terlipressin in Organ Donors in 18 participants. Completed in 12 March 2018.

Timeline

1 January 2015

Primary endpoint
1 January 2018

12 March 2018

Quick facts

Lead sponsor	First Affiliated Hospital, Sun Yat-Sen University
Status	Completed
Study type	OBSERVATIONAL
Enrollment	18
Start date	1 January 2015
Primary completion	1 January 2018
Estimated completion	12 March 2018

Drugs / interventions tested

• terlipressin — full drug profile →

Conditions studied

• Organ Donors — all drugs for Organ Donors →

Sponsor

First Affiliated Hospital, Sun Yat-Sen University

Who can join

Adults 18 to 60, any sex, with Organ Donors. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

During brain death, many significant systemic changes take place and among these, the most notable is hemodynamic instability.

In the pathogenesis of brain death, after the hypertensive phase of the "catecholamine storm", arterial tonus and heart inotropism eventually deteriorate, leading to hypotension and hypoperfusion. Therefore, vasopressor agents are necessary in treatment of brain-dead organ donors. The most commonly used and recommended vasoactive drugs for this indication are dopamine, norepinephrine, and vasopressin.The Transplantation Committee of the American College of Cardiology recommends vasopressin as the primary vasoactive drug for treating hemodynamic instability and diabetes insipidus in brain-death heart donors.

Terlipressin (TP) is a new type of synthetic long-acting vasopressin preparations, AVP long-acting derivatives, belongs to a kind of precursor drugs, itself is inactive, the body through the aminopeptidase, slow "release" of a reactive lysine vasopressin. On the one hand，terlipressin can splanchnic vascular smooth muscle contraction, reduces splanchnic blood flow (e.g., reduce blood flow to the mesenteric, spleen, uterus, etc), to ensure the flow of blood to the important viscera;On the other hand, it reduces the concentration of plasma renin, increases the perfusion of renal blood flow, and improves the glomerular filtration rate, thus improving renal function.From the pharmacological perspective, it is better than arginine vasopressin for the stability of hemodynamics and the perfusion of tissue.

Whether or not it has therapeutic effect on the potential brain death donor with unstable hemodynamics is not studied in the literature at home and abroad.This paper discusses the application value of terlipressin in the management of potential brain death, and provides clinical evidence for the maintenance of brain death donor.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Effects of Terlipressin on Management of Hypotensive Brain-Dead Patients Who are Potential Organ Donors: A Retrospective Study.
   Zheng D, Liu G, Chen L, Xie W, et al · · 2021 · cited 1× · PMID 34658857 · DOI 10.3389/fphar.2021.716759