Clinical trial NCT03477461: Effects of Terlipressin on Management of Potential Organ Donors
Official title: Effects of Terlipressin on Management of Potential Organ Donors：a Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Organ Donors
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2018-03-26
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 18 patients were enrolled. All were potential 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.

Eligibility criteria: 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.

Primary outcomes:
measure: creatinine
timeFrame: Change from Baseline, 24 hours, 72 hours to Before organ procurement
Secondary outcomes:
measure: urine volume
timeFrame: Change from Baseline, 24 hours, 72 hours to Before organ procurement
measure: glomerular filtration rate
timeFrame: Change from Baseline, 24 hours, 72 hours to Before organ procurement
measure: endogenous creatinine clearance rate
timeFrame: Change from Baseline, 24 hours, 72 hours to Before organ procurement
measure: Norepinephrine dose
timeFrame: Change from Baseline, 24 hours, 72 hours to Before organ procurement
Other outcomes:
Locations:
Study officials:
affiliation: First Affiliated Hospital, Sun Yat-Sen University
name: Qiang Tai
role: STUDY_CHAIR
References: