Organ DonorsNCT03477461
Effects of Terlipressin on Management of Potential Organ Donors
An observational study of Organ Donors, run by First Affiliated Hospital, Sun Yat-Sen University.
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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Organ Donors
- What is being tested?
- terlipressin
- Type of treatment
- Injection or infusion
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 12 Mar 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: 18 patients were enrolled. All were potential organ donors.
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Effects of Terlipressin on Management of Potential Organ Donors：a Retrospective Study
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.
Read more
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.
Read the 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.
- Conditions
- Organ Donors
- Being tested
- terlipressin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
terlipressinDrug
a continuous infusion of terlipressin (0.4 mg/kg/h) was initiated
| Study group | Role | What they receive |
|---|---|---|
| terlipressin group | patients presented with oliguria or high levels creatinine Receives: Drug: terlipressin |
What is being measured
The primary outcome is the main question the study is designed to answer.
creatinine
Laboratory values
Measured: Change from Baseline, 24 hours, 72 hours to Before organ procurement
Secondary outcomes (4)
urine volume
observed data
Measured: Change from Baseline, 24 hours, 72 hours to Before organ procurement
glomerular filtration rate
Laboratory values
Measured: Change from Baseline, 24 hours, 72 hours to Before organ procurement
endogenous creatinine clearance rate
Laboratory values
Measured: Change from Baseline, 24 hours, 72 hours to Before organ procurement
Norepinephrine dose
monitoring data
Measured: Change from Baseline, 24 hours, 72 hours to Before organ procurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2018
- Study start1 Jan 2015
- Primary completion1 Jan 2018
- Study completion12 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Organ DonorsStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital, Sun Yat-Sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GengLong Liu, First Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Qiang Tai, Study chair, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03477461
- Sponsor's protocol ID
- Effects of terlipressin
- Status last verified
- Mar 2018
- First submitted
- 13 Mar 2018
- Last updated
- 26 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Terlipressin on Management of Potential Organ Donors：a Retrospective Study
- ClinicalTrials.gov ID
- NCT03477461
- Acronym / sponsor ID
- Effects of terlipressin
- Conditions
- Organ Donors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 12 Mar 2018 (actual)
- First posted
- 26 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| terlipressin group | – | Drug: terlipressinpatients presented with oliguria or high levels creatinine |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 18 patients were enrolled. All were potential organ donors.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| terlipressina continuous infusion of terlipressin (0.4 mg/kg/h) was initiated | Drug | terlipressin group |
Primary outcome
creatinine
Time frame: Change from Baseline, 24 hours, 72 hours to Before organ procurement
Laboratory values
4 secondary outcomes
urine volume
Time frame: Change from Baseline, 24 hours, 72 hours to Before organ procurement
glomerular filtration rate
Time frame: Change from Baseline, 24 hours, 72 hours to Before organ procurement
endogenous creatinine clearance rate
Time frame: Change from Baseline, 24 hours, 72 hours to Before organ procurement
Norepinephrine dose
Time frame: Change from Baseline, 24 hours, 72 hours to Before organ procurement
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qiang Tai study chair
First Affiliated Hospital, Sun Yat-Sen University
Questions about this trial
What is this clinical trial studying?
An observational study of Organ Donors, run by First Affiliated Hospital, Sun Yat-Sen University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
creatinine (time frame: Change from Baseline, 24 hours, 72 hours to Before organ procurement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2018.