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Completed

NCT Number: NCT03477461

Effects of Terlipressin on Management of Potential Organ Donors

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.

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Key information

Conditions

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

3 oliguria or high creatinine.

Exclusion criteria

  • Patients with uremia.
  • Patients with diabetes.
  • There is known to be an allergy to trelin.
  • Previous patients with coronary heart disease.
  • 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.

Treatment and study plan

Terlipressin

Drug

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

Primary outcomes

  1. creatinine

    Time frame: Change from Baseline, 24 hours, 72 hours to Before organ procurement

    Laboratory values

Secondary outcomes

  1. urine volume

    Time frame: Change from Baseline, 24 hours, 72 hours to Before organ procurement

    observed data

  2. glomerular filtration rate

    Time frame: Change from Baseline, 24 hours, 72 hours to Before organ procurement

    Laboratory values

  3. endogenous creatinine clearance rate

    Time frame: Change from Baseline, 24 hours, 72 hours to Before organ procurement

    Laboratory values

  4. Norepinephrine dose

    Time frame: Change from Baseline, 24 hours, 72 hours to Before organ procurement

    monitoring data

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital, Sun Yat-Sen University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Mar 26, 2018
Registry last updated
Mar 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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