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Postperfusion SyndromeNCT05658120

Reperfusion Syndrome and Vasoplegic Syndrome in Liver Transplant Surgery

An observational study of Postperfusion Syndrome, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The incidence of postreperfusion syndrome (PRS) and vasoplegic syndrome (VS) is unknown, and occasionally can be confused since these syndromes share some hemodynamic characteristics. In these cases, monitoring with Swan Ganz catheter may be useful to make the differential diagnosis. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Postperfusion Syndrome
What is being tested?
noradrenaline/adrenaline
How many people
246 participants
Where
1 siteSpain
Study dates
13 Dec 2022to 18 Feb 2023
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Consecutive patients ≥ 18 years-old, who underwent liver transplant surgery, monitored with Swan-Ganz catheter, with norepinephrine/adrenaline support during transplant surgery

Who may be able to join

None listed.

Who cannot join

  • Acute liver failure, combined liver/kidney transplantation, re-transplantation, living-donor related transplantation, moderate to severe vascular and valvular heart disease, chronic kidney disease (serum creatinine > 1.5), moderate and sever hepato-pulmonary syndrome, moderate and sever porto-pulmonary syndrome

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • Vall d´Hebron Research Institute VHIR

    Barcelona, 08035

Other trials in Spain

About this study

Official title: Risk Factors and Postoperative Complications of Reperfusion Syndrome and Vasoplegic Syndrome in Patients With Vasoactive Support During Liver Transplant Surgery

The incidence of postreperfusion syndrome (PRS) and vasoplegic syndrome (VS) is unknown, and occasionally can be confused since these syndromes share some hemodynamic characteristics. In these cases, monitoring with Swan Ganz catheter may be useful to make the differential diagnosis. The main outcome was to analyze reperfusion syndrome and vasoplegic syndrome in patients receiving vasoactive support during liver transplant surgery, in terms of incidence, risk factors and postoperative complications.

Read the detailed description

Introduction:

At the time of the liver reperfusion, many inflammatory mediators coming from the liver graft to the systemic circulation produce a sudden load of cold and acidotic blood. At this stage of graft revascularization, it has been seen an increase of pulmonary vascular resistance index (PVRI) and pulmonary arterial pressure (PAP) and a reduction in systemic vascular resistance index (SVR), heart rate (HR), cardiac index (CI) and arterial blood pressure (ABP).

In this context, some patients suffer postreperfusion syndrome (PRS). This syndrome was first defined by Aggarwal et al as a decrease in the MAP greater than 30% of at least one minute duration and during the five minutes following the portal unclamping and was associated with several preoperative risk factors and postoperative complications. The variety of the risk factors presented in previous studies suggest that the PRS occurs in an unpredictable manner. These risk factors were described related to the organ of the donor; related to the recipient of the liver graft, and related to the surgical technique. The incidence varies largely among the considered studies, ranging from 12% to 77% and it can respond not only to preoperative and intraoperative factors associated with anesthetic-surgical practice, but also to the different criteria for definition of PRS as well as to the administration of vasoactive drugs to prevent or treat it.

On the other hand, the incidence of vasoplegic syndrome (VS) is not described and could be confused with PRS We studied the patients who received vasoactive support during liver transplant surgery and presented PRS considering the Aggarwal et al. definition, and VS considering the Ozal et al. criteria.

Methods:

Design: Retrospective observational study. Inclusion criteria: Patients undergoing liver transplantation who received vasoactive support and monitored with Swan Ganz catheter Exclusion criteria: liver transplantation for acute liver failure, combined liver and kidney transplantation, renal dysfunction (glomerular filtration <60), moderate/severe vascular and valvular heart disease, moderate/severe hepatopulmonary syndrome, moderate/severe portopulmonary syndrome, and re-transplantation

  • Study outcomes The primary objective of our study was to determine the incidence and risk factors of PRS and VS in norepinephrine/adrenaline patients according to the Aggarwal and Ozal criteria respectively. The second objective is to determine the postoperative complications.
  • Data collection Preoperative variables related to recipient and donor were analyzed. Intraoperative variables were recorded at each stage of the surgery: pulmonary capillary wedge pressure (PCWP), mean pulmonary arterial pressure (mPAP), MAP, heart rate (HR), cardiac index (CI), systemic vascular resistance index (SVRI), central venous pressure (CVP), bleeding, need for transfusions, doses of vasoconstrictors, global requirements for bicarbonate and calcium chloride, presence of malignant arrhythmias (fibrilation, flutter, ventricular tachycardia) or ischemic electrocardiographic abnormalities. The times of each surgical phase, duration of cold ischemia and the weights of the liver (donor/recipient) were recorded too. Postoperative data collected included: graft rejection, a second surgery after liver transplant, the need for re-transplantation, renal dysfunction (glomerular filtration <60), hospital stay, days of hospitalization and survival.

All items that could be used to identify the patient (clinical record ID number or name) were removed to protect personal data.

-Measurement of hemodynamic data The hemodynamic parameters (MAP, HR, SVR, CVP, CI, PCWP and mPAP) of each stage of the liver transplant surgery (dissection phase, anhepatic phase prior to unclamping of the IVC, at 1 and 5 min after graft reperfusion, and in the neohepatic phase after completion of the vascular anastomosis) were collected.

The PRS criteria were decrease in the mean arterial pressure ≥ 30% mmHg during the first 5 minutes after unclamping of the IPV, decrease in CI and SVR respect to baseline (anhepatic phase), and increase of the PCWP, CVP and mPAP respect to baseline.

Association between PRS and preoperative, intraoperative, and postoperative variables were analyzed and compared between the two groups (for PRS + and PRS - groups).

Being tested
noradrenaline/adrenaline
Keywords
postreperfusion syndrome, vasoplegic syndrome
Medical subject headings
Vasoplegia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • noradrenaline/adrenalineDrug

    Also called Swan-Ganz catheter monitoring

    norepinephrine adrenaline in patients with Swan-Ganz catheter monitoring during liver transplantation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. incidence of PRS and VS

    Incidence of PRS and VS in patients undergoing liver transplantation

    Measured: in the first 5 min after vascular unclamping

Secondary outcomes (1)
  1. postoperative complications

    Determie the postoperative complications in patients with PRS and VS

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Dec 2022
  2. Study start13 Dec 2022
  3. Primary completion13 Dec 2022
  4. Study completion18 Feb 2023

Resources

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
Cohort
Time perspective
Retrospective
Enrolment
246 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05658120
Sponsor's protocol ID
PR(AG)460/2017
Status last verified
Dec 2022
First submitted
12 Dec 2022
Last updated
21 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: there is no plan

Publications

  • Ozal E, Kuralay E, Yildirim V, Kilic S, Bolcal C, Kucukarslan N, Gunay C, Demirkilic U, Tatar H. Preoperative methylene blue administration in patients at high risk for vasoplegic syndrome during cardiac surgery. Ann Thorac Surg. 2005 May;79(5):1615-9. doi: 10.1016/j.athoracsur.2004.10.038.

    PubMed 15854942
  • Aggarwal S, Kang Y, Freeman JA, Fortunato FL, Pinsky MR. Postreperfusion syndrome: cardiovascular collapse following hepatic reperfusion during liver transplantation. Transplant Proc. 1987 Aug;19(4 Suppl 3):54-5. No abstract available.

    PubMed 3303534

Questions about this trial

What is this clinical trial studying?

An observational study of Postperfusion Syndrome, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.

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 0 inclusion and 1 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 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

incidence of PRS and VS (time frame: in the first 5 min after vascular unclamping). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05658120, which also lists 2 linked publications.

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 21 Feb 2023.

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