Clinical trial NCT05706857: Evaluation of the Clinical Impact of Ultra Fast-Track in Patients Undergoing Cardiac Surgery
Official title: Evaluation of the Clinical Impact of Ultra Fast-Track in Patients Undergoing Cardiac Surgery Versus Conventional Extubation (CARDU-FAST)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Disease
Surgery
Anesthesia
Lead sponsor: Hospital San Carlos, Madrid
Sponsor class: OTHER
First posted: 2023-01-31
Enrollment: 612
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Randomized 1:1. Stratified by type of surgery (CABG, Valvular, Aorta)
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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:

1. Pregnancy.
2. Emergent surgery or cardiorespiratory arrest.
3. Patient in preoperative cardiogenic shock, or in need of high-dose vasoactive support.
4. Aortic arch procedures.
5. Procedures in which hypothermia \< 28ºC of temperature is expected during the intervention.
6. Minor cardiac surgery procedures.
7. 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).
8. Implantation of circulatory assistance devices or ECMO (extracorporeal membrane oxygenation).
9. Active endocarditis.

Primary outcomes:
measure: Determine the effect of Ultra Fast-track
timeFrame: 1 year
Secondary outcomes:
measure: Procedural resources conpsumption
timeFrame: 1 year
measure: Differences in the need for high flow nasal oxygen therapy or non-invasive ventilation for >24h.
timeFrame: 1 year
measure: Differences in major bleeding or life-threatening bleeding.
timeFrame: 1 year
measure: Differences in neurological complication
timeFrame: 1 year
measure: Differences in the incidence of acute myocardial infarction.
timeFrame: 1 year
measure: Differences in the incidence of heart reoperation
timeFrame: 1 year
measure: Differences in the incidence of infections rate.
timeFrame: 1 year
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
Study officials:
affiliation: Hospital San Carlos, Madrid
name: Lourdes Montero Cruces
role: PRINCIPAL_INVESTIGATOR
References: