Overview
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.
Description
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:
- Medical history (previous endocrine diseases, daily medications), pre-admission functional capacity, frailty, and nutritional history obtained via relative questionnaires.
- Serial blood gas analyses, coagulation profiles, standard metabolic panels, and detailed thyroid axis hormone levels (free T3, free T4, rT3, TSH) are obtained during routine clinical care.
- Daily echocardiography measurements and invasive hemodynamic monitoring.
- Mechanical ventilation modes and respiratory data, temporary mechanical circulatory support machine settings/parameters, continuous renal replacement therapy (CRRT) / hemoperfusion details, administered infusions, drugs and detailed enteral/parenteral nutrition tracking.
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.
Eligibility
Inclusion Criteria:
- Adult patients (age ≥ 18 years)
- Treatment with ECMO and/or Impella support
- Informed consent provided by the patients next of kin/ legal representative
Exclusion Criteria:
- None
