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Completed

NCT Number: NCT05706857

Evaluation of the Clinical Impact of Ultra Fast-Track in Patients Undergoing Cardiac Surgery

Single center randomized clinical trial. The main aim is to demonstrate the superiority at the clinical level of the ultra fast-track programs versus conventional early postoperative extubation in patients undergoing cardiac surgery.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Clínico San Carlos

Madrid, 28040, Spain

About this study

The study is aimed to compare clinical superiority of ultra fast-track versus conventional early postoperative extubation in patients undergoing cardiac surgery in our center. The estimated sample size is 612 patients. They will be randomized 1:1 to any of the two arms of the study (ultra fast-track vs. fast-track). The randomization will be stratified according the type of surgery performed. The period of recruitment will start in January 2023 and is supposed to finish by September 2024 or earlier. The main outcomes of the study will be measured 1 year after the procedure.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients over 18 years of age.
  • Patients with valvular, coronary or aortic heart disease with an indication for major cardiac surgery.
  • The patient's desire to participate in the clinical trial verified by signing the informed consent.

Exclusion criteria

  • Pregnancy.
  • Emergent surgery or cardiorespiratory arrest.
  • Patient in preoperative cardiogenic shock, or in need of high-dose vasoactive support.
  • Aortic arch procedures.
  • Procedures in which hypothermia < 28ºC of temperature is expected during the intervention.
  • Minor cardiac surgery procedures.
  • Procedures with minimally invasive techniques without extracorporeal circulation (Transcatheter aortic valve implantation, Transcatheter mitral valve implantation, Minimally invasive mitral valve repair (TOP-Mini), Totally thoracoscopic MAZE procedure, Minimally invasive direct coronary artery bypass grafting).
  • Implantation of circulatory assistance devices or ECMO (extracorporeal membrane oxygenation).
  • Active endocarditis.

Treatment and study plan

Ultra Fast-track

Behavioral

Patients are extubated in the operating room

Primary outcomes

  1. Determine the effect of Ultra Fast-track

    Time frame: 1 year

    Determine the effect of Ultra Fast-track on the occurrence of the composite outcome composed of all-cause mortality, respiratory complications (prolonged intubation over 24h, reintubation, or pneumonia) and AKIN-III (acute renal failure) in patients undergoing ultra fast-track and patients with conventional postoperative extubation.

Secondary outcomes

  1. Procedural resources conpsumption

    Time frame: 1 year

    Comparison of operating room occupancy time (minutes), ICU stay and overall postoperative stay (days).

  2. Differences in the need for high flow nasal oxygen therapy or non-invasive ventilation for >24h.

    Time frame: 1 year

    Comparison of the need for high flow nasal oxygen therapy or non-invasive ventilation for >24h after the procedure.

  3. Differences in major bleeding or life-threatening bleeding.

    Time frame: 1 year

    Comparison of the event of major bleeding or life-threatening bleeding (VARC 2 definition).

  4. Differences in neurological complication

    Time frame: 1 year

    Comparison of the incidence of neurological complication after the procedure.

  5. Differences in the incidence of acute myocardial infarction.

    Time frame: 1 year

    Comparison of the incidence of acute myocardial infarction after the procedure.

  6. Differences in the incidence of heart reoperation

    Time frame: 1 year

    Comparison of the reoperation rate after the procedure.

  7. Differences in the incidence of infections rate.

    Time frame: 1 year

    Comparison of the incidence of infection that requires intravenous antibiotic therapy, which causes an increase in hospital stay or engage patient's life.

Sponsors and collaborators

Lead sponsor

Hospital San Carlos, Madrid

Other

Registry information

Official study title

Evaluation of the Clinical Impact of Ultra Fast-Track in Patients Undergoing Cardiac Surgery Versus Conventional Extubation (CARDU-FAST)

Acronym: CARDU-FAST

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 31, 2023
Registry last updated
Mar 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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