Effects of Terlipressin on Management of Potential Organ Donors

Effects of Terlipressin on Management of Potential Organ Donors：a Retrospective Study

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.

Study Overview

• Status: Completed
• Conditions: Organ Donors
• Intervention / Treatment: Drug: terlipressin

Detailed Description

Thermodilution cardiac output was measured in triplicate. Hemodynamic parameters were calculated according to standard formulas.Oxygen delivery index (IDO2) was calculated as arterial oxygen content multiplied by CI. Systemic vascular resistance index (SVRI) was calculated as the MAP minus right atrial pressure divided by CI and multiplied by 80. Pulmonary vascular resistance index (PVRI) was calculated as the mean pulmonary artery pressure (PAP) minus pulmonary artery occlusion pressure divided by CI. Left and right ventricular stroke work index (L and RVSWI) were calculated .The following laboratory parameters were collected: bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT),prothrombin time, and thrombocytes.

• Study Type: Observational
• Enrollment (Actual): 18

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

18 patients were enrolled. All were potential organ donors.

Description

Inclusion Criteria:

1. Age 10-60 years old, gender is not limited, accord with brain death standard patient.
2. Complete ethical procedures, have entered the donation procedure and successful donation.

3 oliguria or high creatinine.

Exclusion Criteria:

1. Patients with uremia.
2. Patients with diabetes.
3. There is known to be an allergy to trelin.
4. Previous patients with coronary heart disease.
5. Active digestive tract hemorrhage, liver dysfunction (Child C), severe 6.coagulation dysfunction, and cannot be corrected, or other specific contraindication.

7.Active HIV infection or HIV, mental disorder, etc.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
terlipressin group; patients presented with oliguria or high levels creatinine	Drug: terlipressin; a continuous infusion of terlipressin (0.4 mg/kg/h) was initiated

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
creatinine	Laboratory values	Change from Baseline, 24 hours, 72 hours to Before organ procurement

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
urine volume	observed data	Change from Baseline, 24 hours, 72 hours to Before organ procurement
glomerular filtration rate	Laboratory values	Change from Baseline, 24 hours, 72 hours to Before organ procurement
endogenous creatinine clearance rate	Laboratory values	Change from Baseline, 24 hours, 72 hours to Before organ procurement
Norepinephrine dose	monitoring data	Change from Baseline, 24 hours, 72 hours to Before organ procurement

Collaborators and Investigators

• Sponsor: First Affiliated Hospital, Sun Yat-Sen University
• Investigators: Study Chair: Qiang Tai, First Affiliated Hospital, Sun Yat-Sen University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2015
• Primary Completion (ACTUAL): January 1, 2018
• Study Completion (ACTUAL): March 12, 2018

Study Registration Dates

• First Submitted: March 13, 2018
• First Submitted That Met QC Criteria: March 23, 2018
• First Posted (ACTUAL): March 26, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 26, 2018
• Last Update Submitted That Met QC Criteria: March 23, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Antihypertensive Agents; Vasoconstrictor Agents; Terlipressin
• Other Study ID Numbers: Effects of terlipressin

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No