Effects of Terlipressin on Management of Potential Organ Donors

Completed

• Conditions: Organ Donors
• Interventions: Drug: terlipressin

• Registration Number: NCT03477461
• Lead Sponsor: First Affiliated Hospital, Sun Yat-Sen University

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.

Study Timeline

• Study Start: 2015-01-01
• Primary Completion: 2018-01-01
• Status Verified: 2018-03
• Study Completion: 2018-03-12
• Study First Submitted: 2018-03-13
• Study First Submitted QC: 2018-03-23
• Last Update Submitted: 2018-03-23
• Study First Posted: 2018-03-26
• Last Update Posted: 2018-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
terlipressin group	terlipressin	patients presented with oliguria or high levels creatinine

Primary Outcome Measures

Name	Time	Method
creatinine	Change from Baseline, 24 hours, 72 hours to Before organ procurement	Laboratory values

Secondary Outcome Measures

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