ECMOPred-vvva: Prediction of Conversion From Vv-ECMO to Va-ECMO in COVID-19 Patients

Sponsor
Kepler University Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05910996
Collaborator
(none)
250
5

Study Details

Study Description

Brief Summary

In December 2019, cases of a novel lung disease, later referred to as COVID-19, were first reported in China. The virus SARS-CoV-2 was identified as the causative agent. Due to the sharp increase in the number of cases worldwide, a pandemic outbreak was declared by WHO in March 2020.

The infection presents with a broad clinical spectrum. Frequently, there is respiratory infection with fever (80%), dry cough (56%), fatigue (22%), and muscle pain (7%), but completely asymptomatic infection is also possible. Severe courses may be associated with pneumonia resulting in acute respiratory distress syndrome (ARDS) requiring intensive care.

In the context of intensive care therapy, it is sometimes necessary to use extracorporeal organ replacement procedures due to increasing lung failure. In this context, extracorporeal membrane oxygenation (ECMO) was used during the pandemic. With this procedure it is possible to replace on the one hand the oxygenation and ventilation function of the lung and on the other hand additionally the pumping function of the heart, if configured appropriately. The switch from venovenous (vv) configuration, with which only lung function is replaced, to venoarterial (va) configuration (lung function and heart function are replaced) is made in cases of intensive care necessity, e.g., increasing decompensation of heart failure.

Heart failure manifests itself, among other things, through insufficient pumping function of the heart muscle. This results in an undersupply of peripheral tissues with arterial blood, leading to increased anaerobic glycolysis. Lactate and B-type natriuretic peptide (BNP) are used as surrogate parameters of this undersupply. Increased oxygen depletion from oxygen available in arterial blood is detected by the surrogate parameter central venous oxygen saturation (ScvO2).

In addition to ECMO, drug interventions are also used to improve cardiorespiratory performance at various doses. As described by Suwalski et al, there may be a relationship between this drug therapy and conversion from vv to va ECMO.

Currently, few studies exist on conversion from vv-ECMO to va-ECMO. In this regard, Suwalski et al. describe a population that experienced any ECMO therapy for a maximum period of 16.5 ± 10.0 days, with the group with conversion receiving 17.8 ± 10.5 days of therapy and the group without conversion receiving 16.4 ± 9.4 days. The need for conversion to va-ECMO requires additional expertise that is not readily available despite acute intensive care transport readiness. It is likely that by predicting the need for conversion, early logistical planning for transfer to an appropriate center with experience and equipment can occur, or if transfer is not necessary, staffing and equipment preparation can occur earlier and more safely. As described by Falk et al, planned and prepared conversion can also be expected to have an impact on patient* survival.

The aim of this retrospective, exploratory data analysis is to predict conversion before placement of vv-ECMO within 30 days from ICU care from vv-ECMO to va-ECMO in COVID-19 patients.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Conversion from vv-ECMO to va-ECMO

Study Design

Study Type:
Observational
Anticipated Enrollment :
250 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Prediction of Conversion From Vv-ECMO to Va-ECMO in COVID-19 Patients
Anticipated Study Start Date :
Jul 31, 2023
Anticipated Primary Completion Date :
Aug 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Conversion from vv-ECMO to va-ECMO Positive

Procedure: Conversion from vv-ECMO to va-ECMO
Conversion from vv-ECMO to va-ECMO

Conversion from vv-ECMO to va-ECMO Negative

Outcome Measures

Primary Outcome Measures

  1. Confusion Matrix [2019-12-01 to 2023-07-01]

    Confusion Matrix for Classification of Conversion from vv-ECMO to va-ECMO

Secondary Outcome Measures

  1. Mortality [2019-12-01 to 2023-07-01]

    7, 14, and 30 Day-In Hospital Mortality

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • COVID-19 positive patients aged 18 years or older that were treated in intensive care at the study center between 2019-12-01 and 2023-04-15.
Exclusion Criteria:
  • Patients in which ECMO therapy was started outside of the study center.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Kepler University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kepler University Hospital
ClinicalTrials.gov Identifier:
NCT05910996
Other Study ID Numbers:
  • ECMOPred-vvva
First Posted:
Jun 20, 2023
Last Update Posted:
Jun 28, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jun 28, 2023