NCT05658120

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
246

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 12, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

December 13, 2022

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 20, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 18, 2023

Completed
Last Updated

February 21, 2023

Status Verified

December 1, 2022

Enrollment Period

Same day

First QC Date

December 12, 2022

Last Update Submit

February 18, 2023

Conditions

Keywords

postreperfusion syndromevasoplegic syndrome

Outcome Measures

Primary Outcomes (1)

  • incidence of PRS and VS

    Incidence of PRS and VS in patients undergoing liver transplantation

    in the first 5 min after vascular unclamping

Secondary Outcomes (1)

  • postoperative complications

    3 months

Interventions

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

Also known as: Swan-Ganz catheter monitoring

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vall d´Hebron Research Institute VHIR

Barcelona, 08035, Spain

Location

Related Publications (2)

  • 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.

    PMID: 15854942BACKGROUND
  • 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.

MeSH Terms

Conditions

Vasoplegia

Interventions

NorepinephrineEpinephrine

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2022

First Posted

December 20, 2022

Study Start

December 13, 2022

Primary Completion

December 13, 2022

Study Completion

February 18, 2023

Last Updated

February 21, 2023

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

there is no plan

Locations