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Effects of Terlipressin on Management of Potential Organ Donors

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03477461
Enrollment
18
Registered
2018-03-26
Start date
2015-01-01
Completion date
2018-03-12
Last updated
2018-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Organ Donors

Brief summary

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.

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.

Interventions

DRUGterlipressin

a continuous infusion of terlipressin (0.4 mg/kg/h) was initiated

Sponsors

First Affiliated Hospital, Sun Yat-Sen University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
creatinineChange from Baseline, 24 hours, 72 hours to Before organ procurementLaboratory values

Secondary

MeasureTime frameDescription
urine volumeChange from Baseline, 24 hours, 72 hours to Before organ procurementobserved data
glomerular filtration rateChange from Baseline, 24 hours, 72 hours to Before organ procurementLaboratory values
endogenous creatinine clearance rateChange from Baseline, 24 hours, 72 hours to Before organ procurementLaboratory values
Norepinephrine doseChange from Baseline, 24 hours, 72 hours to Before organ procurementmonitoring data

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026