An observational study in Cardiogenic Shock, Euthyroid Sick Syndrome and Critical Illness, sponsored by Gottsegen National Cardiovascular Institute. Recruiting at 1 site in Hungary. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Gottsegen National Cardiovascular Institute · Observational
This prospective, single-center, consecutive observational study evaluates clinical, metabolic, and endocrine factors influencing survival and clinical outcomes in adult patients undergoing temporary mechanical circulatory support at the Cardiovascular Intensive Care Unit of Gottsegen Gyorgy National Cardiovascular Institute.
While traditional cardiovascular risk factors in critically ill patients are well established, non-cardiovascular variables such as endocrine dysfunction, previous functional and nutritional status, metabolic parameters and clinical complications significantly impact short- and long-term outcomes.
The study consecutively enrolls all eligible adult patients admitted to the intensive care unit requiring extracorporeal membrane oxygenation (ECMO) or Impella treatment. The primary objective is to evaluate 28-day and ICU mortality, while secondary objectives include characterizing cardiac and non-cardiac complications, nutritional status changes, and hormonal dysregulations.
Temporary mechanical circulatory support, including Extracorporeal Membrane Oxygenation (ECMO) and Impella, is increasingly used in refractory cardiogenic shock and severe cardiopulmonary failure. Despite major technological advancements and the constant refinements in critical care medicine, mortality in this group remains significant. While traditional hemodynamic and cardiac parameters are known risk factors, non-cardiac parameters such as acute metabolic destabilization, alterations in the hypothalamic-pituitary axis causing endocrine dysregulations (such as euthyroid sick syndrome) and nutritional deficiency play a critical role in the patients outcomes.
The primary objective is to identify independent predictors of mortality and clinical outcomes in patients requiring ECMO or Impella support, with particular focus on dynamic changes in metabolic status and thyroid hormone axes during critical illness. This is a prospective, single-center, consecutive observational cohort study conducted in a high-volume, tertiary cardiac intensive care center. Adult patients treated with ECMO or Impella will be enrolled upon consent. Upon enrollment the following data is to be colleted:
High-density data collection is conducted daily while the patient stays in the Cardiovascular Intensive Care Unit. If patient management is stepped down within the Institute, routine laboratory parameters continue to be tracked until hospital discharge. Hard primary endpoints focus on 30-day all-cause mortality and overall ICU mortality. Secondary endpoints involve cardiac and non-cardiac complication rates, nutritional impairment, and endocrine hormone changes. We use the routine treatment angorithms, the study is non-interventional.
281 studies on the registry are indexed under Shock, Cardiogenic; 128 are open to participants now.
This study's planned enrollment of 160 is below the median of 180 across 146 observational studies indexed under Shock, Cardiogenic.
Browse Shock, Cardiogenic studies →Gottsegen National Cardiovascular Institute is the lead sponsor of 4 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All adult (>18 years) patients admitted to the Cardiovascular Intensive Care Unit of Gottsegen Gyorgy National Cardiovascular Institute receiving temporary mechanical circulatory support via ECMO and/or Impella.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
ICU all-cause mortality
All-cause mortality during the Intensive Care Unit stay
Time frame: From date of enrollment until the date of death from any cause or discharge from the Intensive Care Unit, whichever came first, assessed up to 1 year.
28 day all-cause mortality
All-cause mortality following initiation of ECMO or Impella support
Time frame: From date of enrollment until the date of death from any cause, assessed up to 28 days.
Dynamic thyroid and metabolic alterations
Low-T3 syndrome and / or metabolic dysfunction identified using abnormal lab markers during the temporary mechanical circulatory support
Time frame: From date of enrollment until the date of death from any cause or discharge from hospital, whichever came first, assessed up to 1 year.
Cardiovascular and Non-Cardiovascular complications
Incidence of major bleeding, thrombotic events, acute kidney injury, mechanical device failure, severe infections and etc. during ICU stay
Time frame: From date of enrollment until the date of death from any cause or discharge from hospital, whichever came first, assessed up to 1 year
Nutritional and malnutritional intolarence
Incidence of enteral feeding intolerance, malnutrition signs, and caloric/protein deficit during mechanical support
Time frame: From date of enrollment until the date of death from any cause or discharge from hospital, whichever came first, assessed up to 1 year
All cause in-hospital mortality
All-cause mortality during hospital stay
Time frame: From date of enrollment until the date of death from any cause or discharge from hospital, whichever came first, assessed up to 1 year
Plan to share: Undecided — Anonim data will be shared upon reasonable request.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Gottsegen National Cardiovascular Institute