Effects of Terlipressin on Management of Potential Organ Donors

NCT03477461 | Completed DMC

• 1 other identifier: Effects of terlipressin
• Study Type: observational
• Target: 18
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Organ Donors

Outcome Measures

Primary Outcomes (1)

• creatinine

  Laboratory values

  Change from Baseline, 24 hours, 72 hours to Before organ procurement

Secondary Outcomes (4)

• urine volume

  Change from Baseline, 24 hours, 72 hours to Before organ procurement

• glomerular filtration rate

  Change from Baseline, 24 hours, 72 hours to Before organ procurement

• endogenous creatinine clearance rate

  Change from Baseline, 24 hours, 72 hours to Before organ procurement

• Norepinephrine dose

  Change from Baseline, 24 hours, 72 hours to Before organ procurement

Study Arms (1)

terlipressin group

patients presented with oliguria or high levels creatinine

Drug: terlipressin

Interventions

terlipressin DRUG

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

terlipressin group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

18 patients were enrolled. All were potential organ donors.

You may qualify if:

• 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.
• oliguria or high creatinine.

You may not qualify if:

• 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.
• Active HIV infection or HIV, mental disorder, etc.

Sponsors & Collaborators

• First Affiliated Hospital, Sun Yat-Sen University: lead

MeSH Terms

Interventions

Terlipressin

Intervention Hierarchy (Ancestors)

Lypressin; Vasopressins; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Qiang Tai

  First Affiliated Hospital, Sun Yat-Sen University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 13, 2018
• First Posted: March 26, 2018
• Study Start: January 1, 2015
• Primary Completion: January 1, 2018
• Study Completion: March 12, 2018
• Last Updated: March 26, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share