Factors Influencing Outcomes in ECMO and Impella Patients: Metabolic and Thyroid Hormone Dynamics

NCT07885618 | Recruiting

• 1 other identifier: OOI RKEB00041-1/2026
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiogenic Shock; Critical Illness; Euthyroid Sick Syndrome

Keywords

ECMO; Impella; Mechanical Circulatory Support; Critical Care; Nutritional Status; Thyroid Hormones

Outcome Measures

Primary Outcomes (2)

• ICU all-cause mortality

  All-cause mortality during the Intensive Care Unit stay

  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

  From date of enrollment until the date of death from any cause, assessed up to 28 days.

Secondary Outcomes (4)

• Dynamic thyroid and metabolic alterations

  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

  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

  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

  From date of enrollment until the date of death from any cause or discharge from hospital, whichever came first, assessed up to 1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Adult patients (age ≥ 18 years)
• Treatment with ECMO and/or Impella support
• Informed consent provided by the patients next of kin/ legal representative

You may not qualify if:

• None

Sponsors & Collaborators

• Gottsegen National Cardiovascular Institute: lead

Study Sites (1)

Gottsegen Gyorgy National Cardiovascular Center

Budapest, 1096, Hungary

RECRUITING

Related Publications (17)

• Bear DE, Ridley EJ, Daly K, De Waele E, Al Dabbous T, Karpasiti T, Stoppe C, Barrett NA. 2025 ELSO Consensus Statement for the Provision and Management of Nutrition Therapy in Critically Ill Adult Patients Requiring Extracorporeal Membrane Oxygenation. ASAIO J. 2026 Feb 1;72(2):99-110. doi: 10.1097/MAT.0000000000002657. Epub 2026 Jan 22.

  PMID: 41588618 BACKGROUND

• Ramsey S, Shehatta AL, Ramanathan K, Shekar K, Brodie D, Diaz R, Roberts A, Cruz S, Hodgson C, Zakhary B. Extracorporeal Life Support Organization 2024 Guideline for Early Rehabilitation or Mobilization of Adult Patients on Extracorporeal Membrane Oxygenation. ASAIO J. 2025 Mar 1;71(3):187-199. doi: 10.1097/MAT.0000000000002375. Epub 2025 Jan 30.

  PMID: 39883803 BACKGROUND

• Hiser SL, Casey K, Nydahl P, Hodgson CL, Needham DM. Intensive care unit acquired weakness and physical rehabilitation in the ICU. BMJ. 2025 Jan 27;388:e077292. doi: 10.1136/bmj-2023-077292.

  PMID: 39870417 BACKGROUND

• Dresen E, Naidoo O, Hill A, Elke G, Lindner M, Jonckheer J, De Waele E, Meybohm P, Modir R, Patel JJ, Christopher KB, Stoppe C. Medical nutrition therapy in patients receiving ECMO: Evidence-based guidance for clinical practice. JPEN J Parenter Enteral Nutr. 2023 Feb;47(2):220-235. doi: 10.1002/jpen.2467. Epub 2022 Dec 29.

  PMID: 36495215 BACKGROUND

• Bridges BC, Dhar A, Ramanathan K, Steflik HJ, Schmidt M, Shekar K. Extracorporeal Life Support Organization Guidelines for Fluid Overload, Acute Kidney Injury, and Electrolyte Management. ASAIO J. 2022 May 1;68(5):611-618. doi: 10.1097/MAT.0000000000001702. Epub 2022 Mar 25.

  PMID: 35348527 BACKGROUND

• Leeuwen L, van Heijst AFJ, van Rosmalen J, de Rijke YB, Beurskens LWJE, Tibboel D, van den Akker ELT, IJsselstijn H. Changes in thyroid hormone concentrations during neonatal extracorporeal membrane oxygenation. J Perinatol. 2017 Aug;37(8):906-910. doi: 10.1038/jp.2017.56. Epub 2017 Apr 27.

  PMID: 28448064 BACKGROUND

• Holndonner-Kirst E, Nagy A, Czobor NR, Fazekas L, Dohan O, Kertai MD, Lex DJ, Sax B, Hartyanszky I, Merkely B, Gal J, Szekely A. The Impact of l-Thyroxine Treatment of Donors and Recipients on Postoperative Outcomes After Heart Transplantation. J Cardiothorac Vasc Anesth. 2019 Jun;33(6):1629-1635. doi: 10.1053/j.jvca.2018.10.024. Epub 2018 Oct 25.

  PMID: 30467031 BACKGROUND

• Kozdag G, Ural D, Vural A, Agacdiken A, Kahraman G, Sahin T, Ural E, Komsuoglu B. Relation between free triiodothyronine/free thyroxine ratio, echocardiographic parameters and mortality in dilated cardiomyopathy. Eur J Heart Fail. 2005 Jan;7(1):113-8. doi: 10.1016/j.ejheart.2004.04.016.

  PMID: 15642542 BACKGROUND

• Pingitore A, Iervasi G. Thyroid (dys)function in heart failure: is it a potential target for medical treatment? Vasc Health Risk Manag. 2005;1(2):97-100. doi: 10.2147/vhrm.1.2.97.64076. No abstract available.

  PMID: 17315395 BACKGROUND

• Pingitore A, Landi P, Taddei MC, Ripoli A, L'Abbate A, Iervasi G. Triiodothyronine levels for risk stratification of patients with chronic heart failure. Am J Med. 2005 Feb;118(2):132-6. doi: 10.1016/j.amjmed.2004.07.052.

  PMID: 15694896 BACKGROUND

• Opasich C, Pacini F, Ambrosino N, Riccardi PG, Febo O, Ferrari R, Cobelli F, Tavazzi L. Sick euthyroid syndrome in patients with moderate-to-severe chronic heart failure. Eur Heart J. 1996 Dec;17(12):1860-6. doi: 10.1093/oxfordjournals.eurheartj.a014804.

  PMID: 8960429 BACKGROUND

• Iervasi G, Pingitore A, Landi P, Raciti M, Ripoli A, Scarlattini M, L'Abbate A, Donato L. Low-T3 syndrome: a strong prognostic predictor of death in patients with heart disease. Circulation. 2003 Feb 11;107(5):708-13. doi: 10.1161/01.cir.0000048124.64204.3f.

  PMID: 12578873 BACKGROUND

• Bossone E, Arcopinto M, Iacoviello M, Triggiani V, Cacciatore F, Maiello C, Limongelli G, Masarone D, Perticone F, Sciacqua A, Perrone-Filardi P, Mancini A, Volterrani M, Vriz O, Castello R, Passantino A, Campo M, Modesti PA, De Giorgi A, Monte I, Puzzo A, Ballotta A, Caliendo L, D'Assante R, Marra AM, Salzano A, Suzuki T, Cittadini A; TOSCA Investigators. Multiple hormonal and metabolic deficiency syndrome in chronic heart failure: rationale, design, and demographic characteristics of the T.O.S.CA. Registry. Intern Emerg Med. 2018 Aug;13(5):661-671. doi: 10.1007/s11739-018-1844-8. Epub 2018 Apr 4.

  PMID: 29619769 BACKGROUND

• Mebis L, Debaveye Y, Ellger B, Derde S, Ververs EJ, Langouche L, Darras VM, Fliers E, Visser TJ, Van den Berghe G. Changes in the central component of the hypothalamus-pituitary-thyroid axis in a rabbit model of prolonged critical illness. Crit Care. 2009;13(5):R147. doi: 10.1186/cc8043. Epub 2009 Sep 11.

  PMID: 19747372 BACKGROUND

• Van den Berghe G, de Zegher F, Baxter RC, Veldhuis JD, Wouters P, Schetz M, Verwaest C, Van der Vorst E, Lauwers P, Bouillon R, Bowers CY. Neuroendocrinology of prolonged critical illness: effects of exogenous thyrotropin-releasing hormone and its combination with growth hormone secretagogues. J Clin Endocrinol Metab. 1998 Feb;83(2):309-19. doi: 10.1210/jcem.83.2.4575.

  PMID: 9467533 BACKGROUND

• Klein I, Ojamaa K. Thyroid hormone and the cardiovascular system. N Engl J Med. 2001 Feb 15;344(7):501-9. doi: 10.1056/NEJM200102153440707. No abstract available.

  PMID: 11172193 BACKGROUND

• Richardson ASC, Tonna JE, Nanjayya V, Nixon P, Abrams DC, Raman L, Bernard S, Finney SJ, Grunau B, Youngquist ST, McKellar SH, Shinar Z, Bartos JA, Becker LB, Yannopoulos D, B elohlavek J, Lamhaut L, Pellegrino V. Extracorporeal Cardiopulmonary Resuscitation in Adults. Interim Guideline Consensus Statement From the Extracorporeal Life Support Organization. ASAIO J. 2021 Mar 1;67(3):221-228. doi: 10.1097/MAT.0000000000001344.

  PMID: 33627592 BACKGROUND

MeSH Terms

Conditions

Shock, Cardiogenic; Euthyroid Sick Syndromes; Critical Illness

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock; Thyroid Diseases; Endocrine System Diseases; Disease Attributes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2026
• First Posted: October 21, 2026
• Study Start: August 17, 2026
• Primary Completion (Estimated): June 30, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: October 21, 2026

Record last verified: 2026-10

Locations

HU (1)