Effects of Terlipressin on Management of Potential Organ Donors

Organ Donors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03477461
• Other study ID #: Effects of terlipressin
• Status: Completed
• First received: March 13, 2018
• Last updated: March 23, 2018
• Start date: January 1, 2015
• Est. completion date: March 12, 2018

Study information

• Verified date: March 2018
• Source: First Affiliated Hospital, Sun Yat-Sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: March 12, 2018
• Est. primary completion date: January 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Organ Donors

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital, Sun Yat-Sen University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	creatinine	Laboratory values	Change from Baseline, 24 hours, 72 hours to Before organ procurement
Secondary	urine volume	observed data	Change from Baseline, 24 hours, 72 hours to Before organ procurement
Secondary	glomerular filtration rate	Laboratory values	Change from Baseline, 24 hours, 72 hours to Before organ procurement
Secondary	endogenous creatinine clearance rate	Laboratory values	Change from Baseline, 24 hours, 72 hours to Before organ procurement
Secondary	Norepinephrine dose	monitoring data	Change from Baseline, 24 hours, 72 hours to Before organ procurement